Abstract
Background: A diet low in fermentable oligo-saccharides, di-saccharides, mono-saccharides and polyols (low FODMAP diet) is complex and clinical effectiveness is achieved with dietitian-led education, although dietitian availability in clinical practice varies. This study aimed to assess the feasibility of undertaking a trial to investigate the clinical and cost-effectiveness of different education delivery methods of the low FODMAP diet in patients with disorders of gut–brain interaction (DGBI). Methods: In this feasibility randomized controlled trial, patients with DGBI requiring the low FODMAP diet were randomized to receive one of the following education delivery methods: booklet, app, or dietitian. Recruitment and retention rates, acceptability, symptoms, stool output, quality of life, and dietary intake were assessed. Key Results: Fifty-one patients were randomized with a recruitment rate of 2.4 patients/month and retention of 48 of 51 (94%). Nobody in the booklet group strongly agreed that this education delivery method enabled them to self-manage symptoms without further support, compared to 7 of 14 (50%) in the dietitian group (p = 0.013). More patients reported adequate relief of symptoms in the dietitian group (12, 80%) compared with the booklet group (7, 39%; p = 0.026), but not when compared to the app group (10, 63%, p > 0.05). There was a greater decrease in the IBS-SSS score in the dietitian group (mean −153, SD 90) compared with the booklet group (mean −90, SD 56; p = 0.043), but not when compared with the app group (mean −120, SD 62; p = 0.595). Conclusions & Inferences: Booklets were the least acceptable education delivery methods. Dietitian-led consultations led to high levels of clinical effectiveness, followed by the app, while the dietitian was superior to booklets alone. However, an adequately powered clinical trial is needed to confirm clinical effectiveness of these education delivery methods.
| Original language | English |
|---|---|
| Article number | e14640 |
| Journal | Neurogastroenterology and Motility |
| Volume | 35 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - Oct 2023 |
Keywords
- dietitians
- education
- FODMAP diet
- irritable bowel syndrome
- mobile apps
- smartphone apps
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In: Neurogastroenterology and Motility, Vol. 35, No. 10, e14640, 10.2023.
Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Optimizing educational methods for the low FODMAP diet in disorders of gut–brain interaction
T2 - A feasibility randomized controlled trial
AU - Dimidi, Eirini
AU - McArthur, Alastair James
AU - White, Rachel
AU - Whelan, Kevin
AU - Lomer, Miranda C.E.
N1 - Funding Information: This research was supported from income generation from education course for dietitians and patient resources on a diet low in fermentable oligo-saccharides, di-saccharides, mono-saccharides and polyols (low FODMAP diet). In summary, this study showed that booklets alone were the least acceptable education delivery method of the low FODMAP diet. This highlights that written information may not be an appropriate FODMAP education delivery method and healthcare professionals should not use these in isolation. Receiving education from a dietitian resulted in high levels of clinical effectiveness followed by an app alone, while booklets were inferior to dietitian-led education, though caution is needed when interpreting these findings. Given the lack of access to dietetic services in certain areas and the limited clinical capacity of dietetic services when these are available, there is still a need to identify effective alternative education delivery methods, such as apps, webinars and group education, to ensure equal access to high quality and effective dietary treatment among patients with IBS. To identify such education delivery methods, adequately powered trials are needed in the future to assess the clinical and cost-effectiveness of novel education delivery methods compared to dietitian-led consultations. Finally, this study demonstrated challenges in recruitment of IBS patients from primary care and strategies to maintain retention, which need to be considered in future larger trials. This was the first study to assess the feasibility and effectiveness of using dietitian-independent education delivery methods of the low FODMAP diet in an RCT using an active comparator that reflects best clinical practice. Validated questionnaires were used to assess clinical outcomes, and prospective 7-day diaries were used to assess dietary intakes. As this was a feasibility study, no sample size calculation was performed and, therefore, the study was not adequately powered to compare effectiveness among the different education delivery methods. Thus, caution is needed in interpreting the results and further adequately powered trials are warranted, which this feasibility study now justifies. Another limitation is the lack of blinding, which could have resulted in subject and expectation bias, especially if the group preferences reported by patients at follow-up already existed at baseline.33 In addition, fewer booklet group patients (64%) reported English as their first language, compared to over 90% for the app and dietitian groups. Given that the effectiveness of the booklets would rely on patients' understanding of the written content, it may be possible that patients in this group whose first language was not English may have found the content of the booklets more difficult to interpret. However, all patients reported being able to read and understand English before participating in the trial. In addition, there was a vast difference in the contact time between patients and researchers among the study groups, which may have impacted the findings. However, this time variance was part of the pragmatic study design to mimic real-world practice when patients are provided with booklets alone versus apps alone versus dietetic consultations. For the dietary analysis, there is lack of information on the FODMAP content for some food products and, therefore, the FODMAP content of similar foods was used to calculate FODMAP intake when needed. However, a standardized approach was followed for data entry using pre-specified assumption criteria to eliminate inter-group differences. In addition, underreporting of food intake, as demonstrated by the reported daily energy intake, would have resulted in underreporting of all nutrients and FODMAP intakes reported in the current study. Finally, 84% of patients were females and 77% had a university degree which may limit the generalizability of the results. This is the first study to assess the effectiveness of booklets alone and an app alone in delivering education on the low FODMAP diet, both of which have become common, albeit not recommended, methods for patients learning about the diet. Although the study was not powered to detect differences in clinical outcomes, the findings suggest that dietitian-led consultations were more clinically effective than the app alone followed by the booklet alone, although only the dietitian appears to be statistically superior to booklets even in this feasibility study. Notably, 80% of patients in the dietitian group reported adequate symptom relief compared to 63% in the app group and only 39% in the booklet group. Interestingly, previous studies show that 30%–38% of patients following a placebo diet, which does not decrease FODMAP intake, still report adequate symptom relief28,52; this suggests that the level of effectiveness reported in the booklet group is comparable to that of a placebo response. Previous dietitian-led low FODMAP diet studies report adequate symptom relief in 57%–68% of patients27,28,52,53 which is comparable to both the app and dietitian groups in the current study. Similar findings were demonstrated for change in IBS-SSS score, with the greatest reduction for dietitian, followed by app, then booklet, with the reduction in the dietitian group being statistically significantly greater than that of the booklet group. Thus, although the app was perceived as less acceptable compared to dietitian-led consultations, it shows promise that it may be more effective than booklets alone, warranting further research. Patients describe the provision of booklets as simplistic and prescriptive, and often resort to using additional digital resources, such as apps, to help them follow the diet.17 Indeed, apps that include barcode scanners and food product search functions, to allow the identification of food products suitable for the diet, as well as additional support in the form of education, may be more effective that simplistic non-interactive written information. It is worth noting that the study booklets provided very detailed information over 90 pages, which is considerably longer than the one to two page written information usually provided by physicians. Therefore, it is likely that the acceptability and clinical effectiveness of written information given by physicians are even lower compared to that demonstrated in this study, given the considerably lower amount of information/education that would be included. Over 90% of patients in the app and dietitian groups achieved a minimally clinically important difference in their symptoms, which is considerable higher than that reported in previous studies.11 However, previous studies focused on IBS only, whereas the current study also included patients with functional bloating and functional diarrhea. It is thus possible that the low FODMAP diet is particularly effective in patients with functional bloating and functional diarrhea, leading to higher rate response rates, though this remains to be confirmed via future RCTs. Another possible explanation for the high response rate is the fact that, as this is a feasibility study, it was not adequately powered, and thus the effect size observed may not be a true representation of the actual effect size in the wider population. Despite guidelines suggesting that education on the low FODMAP diet should only be provided by a dietitian, only one-third of patients with functional bowel symptoms have seen a dietitian.7 Although this highlights the need for improved dietetic referral pathways for specialist advice, it also emphasizes the need to identify suitable dietitian-independent education methods that are cost-effective, easily accessible, safe, and effective. Indeed, several education methods have been trialed in IBS. Improved knowledge and confidence in managing IBS was reported in a recent study of 443 patients who watched a dietitian-led webinar on the dietary management of IBS.54 The webinar was produced by dietitians and saved £3500/year in healthcare costs, however its clinical effectiveness has not been confirmed yet.54 Dietitian-led group education has also been shown to be clinically36,55 and cost-effective.36 The current study suggests that digital technology in an app developed by dietitians may also be acceptable and clinically effective, as well as safe, since no detrimental impact was shown on nutrient intake and quality of life. Therefore, apps developed by dietitians may offer a good alternative to patients without access to a dietitian. Despite the differences observed in clinical outcomes among the study groups, no differences were found in energy, nutrient and FODMAP intake. Notably, FODMAP intake varied from 4 to 6 g/d which is lower than previous studies reporting 10–18 g/d in patients advised to follow a low FODMAP diet.28,50 This could be attributed to underreporting as demonstrated by low energy intakes 1552–1713 kcal/d across study groups. The observed improvement in clinical outcomes following dietitian-led consultations is not attributed to lower FODMAP intakes, but could rather be attributed to the additional interaction, discussions, guidance and support patients receive during dietitian-led consultations. Indeed, the vast majority of patients with IBS report their ideal expectations from healthcare professionals are listening, providing support and hope, and demonstrating empathy, with studies showing that a positive patient experience with their healthcare professional is associated with better clinical effectiveness.56,57 This study confirmed that booklets alone were not perceived acceptable for education on the low FODMAP diet, and most patients reported they would have preferred to receive a different education delivery method, contrary to only a minority of the app and the dietitian groups. The booklets lacked the ability to allow patients to understand and implement the low FODMAP diet and to self-manage their symptoms. Further, most patients believed that booklet education did not fit within the goals and culture of the NHS and would not recommend it to their friends and family. A previous study in IBS also demonstrated that patients receiving written information were less satisfied with their knowledge of IBS compared to those receiving structured group education.21 Furthermore, even when patients have correct knowledge of IBS, they doubt they have enough knowledge.51 Therefore, although booklets contain extensive information on IBS and the low FODMAP diet, patients may find information received via dietitian counseling more tailored, easier to process and understand, and perceive dietitian education delivery as more acceptable than booklets. Indeed, a previous study showed that 80 patients with functional gut symptoms who saw a dietitian were more likely to understand the dietary instructions provided and felt they had sufficient knowledge to follow the low FODMAP diet, compared to those who did not see a dietitian.7 Interestingly, in the current study, similar numbers of patients in the app and dietitian education delivery groups strongly agreed to being able to self-manage symptoms, and this was significantly higher than the booklet group. However, fewer patients strongly agreed to being able to understand and implement the low FODMAP diet in the app group compared with the dietitian group. Having the opportunity to ask a dietitian questions, address specific concerns and barriers, and receiving personalized advice may lead to greater reassurance, knowledge, and confidence in implementing the diet compared to the booklets and the app. More patients in the app group disagreed with information on food labels being adequate for confidently choosing suitable low FODMAP foods, compared to the booklet group (but not when compared to the dietitian group). This was an unexpected finding given that the app focuses on scanning product labels and their ingredients to identify their suitability for the low FODMAP diet, ultimately providing a “verdict” to patients on whether a food product is suitable for the diet. However, perhaps this meant that in the app group, patients did not necessarily need to learn to read the food labels thoroughly themselves, since they relied on the app to provide the “verdict” on whether a food was suitable or not altogether. Therefore, patients using the app alone may not have learnt which ingredients are low or high in FODMAPs nor practiced reading food labels enough to identify and understand the suitability of food products on their own. This may have resulted in the “verdicts” provided by the app for food product suitability appearing nonsensical and confusing to patients (e.g., some tomato ketchup brands were suitable while other were not). This highlights the importance of education on the basic principles of the low FODMAP diet prior to using an app to identify suitable food products, so that the results provided in the app are unambiguous to patients. Patient recruitment from primary care was slow. Previous studies, including those with DGBI patients have also reported similar trial recruitment challenges,40–42 with limited responses from GPs and primary care practices approached by researchers, in combination with low numbers of patient referrals from interested primary care practices. Contributing factors include lack of time, insufficient interest in the research topic, lack of financial incentives, and forgetfulness,43,44 the latter highlighting the needs for continuous engagement with GPs. Recruitment rates increase where strategies involve GPs with a specialist interest in the topic, specifically in trial protocol development, as well as providing financial incentives.43,45–48 In addition, support from organizations that promote GP engagement in research is helpful.49 A GP advisor, providing regular project updates and project reminder letters to GPs, receiving support from organizations that support research in primary care, as well as conducting personal practice visits, may help increase GP engagement, address any problems or concerns that may arise in recruiting patients in primary care and, ultimately, increase recruitment.45,49 Interestingly, the retention rate in this study was 94%, which is higher than that reported in previous RCTs that included dietitian-led FODMAP education in IBS in the UK.28,50 This highlights that the study design, including the education delivery methods and assessments used in the current trial did not prevent patients from completing the study, irrespective of which group they were allocated to. This feasibility RCT of dietary education delivery in DGBI showed that dietitian counseling may be more clinically effective in improving functional gut symptoms when compared with booklet education, but not when compared with app education. Education using booklets appears inferior to patients, compared with dietitian counseling and the app. This study also showed slow recruitment from primary care and easing recruitment criteria to include secondary care dietitian referrals and patients with functional bloating/functional diarrhea improved recruitment to an acceptable level. Thus, it is important to overcome these barriers in recruitment to undertake a future trial. The retention rate was higher than expected. Patient recruitment from primary care was slow. Previous studies, including those with DGBI patients have also reported similar trial recruitment challenges,40–42 with limited responses from GPs and primary care practices approached by researchers, in combination with low numbers of patient referrals from interested primary care practices. Contributing factors include lack of time, insufficient interest in the research topic, lack of financial incentives, and forgetfulness,43,44 the latter highlighting the needs for continuous engagement with GPs. Recruitment rates increase where strategies involve GPs with a specialist interest in the topic, specifically in trial protocol development, as well as providing financial incentives.43,45–48 In addition, support from organizations that promote GP engagement in research is helpful.49 A GP advisor, providing regular project updates and project reminder letters to GPs, receiving support from organizations that support research in primary care, as well as conducting personal practice visits, may help increase GP engagement, address any problems or concerns that may arise in recruiting patients in primary care and, ultimately, increase recruitment.45,49 Interestingly, the retention rate in this study was 94%, which is higher than that reported in previous RCTs that included dietitian-led FODMAP education in IBS in the UK.28,50 This highlights that the study design, including the education delivery methods and assessments used in the current trial did not prevent patients from completing the study, irrespective of which group they were allocated to. This study confirmed that booklets alone were not perceived acceptable for education on the low FODMAP diet, and most patients reported they would have preferred to receive a different education delivery method, contrary to only a minority of the app and the dietitian groups. The booklets lacked the ability to allow patients to understand and implement the low FODMAP diet and to self-manage their symptoms. Further, most patients believed that booklet education did not fit within the goals and culture of the NHS and would not recommend it to their friends and family. A previous study in IBS also demonstrated that patients receiving written information were less satisfied with their knowledge of IBS compared to those receiving structured group education.21 Furthermore, even when patients have correct knowledge of IBS, they doubt they have enough knowledge.51 Therefore, although booklets contain extensive information on IBS and the low FODMAP diet, patients may find information received via dietitian counseling more tailored, easier to process and understand, and perceive dietitian education delivery as more acceptable than booklets. Indeed, a previous study showed that 80 patients with functional gut symptoms who saw a dietitian were more likely to understand the dietary instructions provided and felt they had sufficient knowledge to follow the low FODMAP diet, compared to those who did not see a dietitian.7 Interestingly, in the current study, similar numbers of patients in the app and dietitian education delivery groups strongly agreed to being able to self-manage symptoms, and this was significantly higher than the booklet group. However, fewer patients strongly agreed to being able to understand and implement the low FODMAP diet in the app group compared with the dietitian group. Having the opportunity to ask a dietitian questions, address specific concerns and barriers, and receiving personalized advice may lead to greater reassurance, knowledge, and confidence in implementing the diet compared to the booklets and the app. More patients in the app group disagreed with information on food labels being adequate for confidently choosing suitable low FODMAP foods, compared to the booklet group (but not when compared to the dietitian group). This was an unexpected finding given that the app focuses on scanning product labels and their ingredients to identify their suitability for the low FODMAP diet, ultimately providing a “verdict” to patients on whether a food product is suitable for the diet. However, perhaps this meant that in the app group, patients did not necessarily need to learn to read the food labels thoroughly themselves, since they relied on the app to provide the “verdict” on whether a food was suitable or not altogether. Therefore, patients using the app alone may not have learnt which ingredients are low or high in FODMAPs nor practiced reading food labels enough to identify and understand the suitability of food products on their own. This may have resulted in the “verdicts” provided by the app for food product suitability appearing nonsensical and confusing to patients (e.g., some tomato ketchup brands were suitable while other were not). This highlights the importance of education on the basic principles of the low FODMAP diet prior to using an app to identify suitable food products, so that the results provided in the app are unambiguous to patients. This is the first study to assess the effectiveness of booklets alone and an app alone in delivering education on the low FODMAP diet, both of which have become common, albeit not recommended, methods for patients learning about the diet. Although the study was not powered to detect differences in clinical outcomes, the findings suggest that dietitian-led consultations were more clinically effective than the app alone followed by the booklet alone, although only the dietitian appears to be statistically superior to booklets even in this feasibility study. Notably, 80% of patients in the dietitian group reported adequate symptom relief compared to 63% in the app group and only 39% in the booklet group. Interestingly, previous studies show that 30%–38% of patients following a placebo diet, which does not decrease FODMAP intake, still report adequate symptom relief28,52; this suggests that the level of effectiveness reported in the booklet group is comparable to that of a placebo response. Previous dietitian-led low FODMAP diet studies report adequate symptom relief in 57%–68% of patients27,28,52,53 which is comparable to both the app and dietitian groups in the current study. Similar findings were demonstrated for change in IBS-SSS score, with the greatest reduction for dietitian, followed by app, then booklet, with the reduction in the dietitian group being statistically significantly greater than that of the booklet group. Thus, although the app was perceived as less acceptable compared to dietitian-led consultations, it shows promise that it may be more effective than booklets alone, warranting further research. Patients describe the provision of booklets as simplistic and prescriptive, and often resort to using additional digital resources, such as apps, to help them follow the diet.17 Indeed, apps that include barcode scanners and food product search functions, to allow the identification of food products suitable for the diet, as well as additional support in the form of education, may be more effective that simplistic non-interactive written information. It is worth noting that the study booklets provided very detailed information over 90 pages, which is considerably longer than the one to two page written information usually provided by physicians. Therefore, it is likely that the acceptability and clinical effectiveness of written information given by physicians are even lower compared to that demonstrated in this study, given the considerably lower amount of information/education that would be included. Over 90% of patients in the app and dietitian groups achieved a minimally clinically important difference in their symptoms, which is considerable higher than that reported in previous studies.11 However, previous studies focused on IBS only, whereas the current study also included patients with functional bloating and functional diarrhea. It is thus possible that the low FODMAP diet is particularly effective in patients with functional bloating and functional diarrhea, leading to higher rate response rates, though this remains to be confirmed via future RCTs. Another possible explanation for the high response rate is the fact that, as this is a feasibility study, it was not adequately powered, and thus the effect size observed may not be a true representation of the actual effect size in the wider population. Despite guidelines suggesting that education on the low FODMAP diet should only be provided by a dietitian, only one-third of patients with functional bowel symptoms have seen a dietitian.7 Although this highlights the need for improved dietetic referral pathways for specialist advice, it also emphasizes the need to identify suitable dietitian-independent education methods that are cost-effective, easily accessible, safe, and effective. Indeed, several education methods have been trialed in IBS. Improved knowledge and confidence in managing IBS was reported in a recent study of 443 patients who watched a dietitian-led webinar on the dietary management of IBS.54 The webinar was produced by dietitians and saved £3500/year in healthcare costs, however its clinical effectiveness has not been confirmed yet.54 Dietitian-led group education has also been shown to be clinically36,55 and cost-effective.36 The current study suggests that digital technology in an app developed by dietitians may also be acceptable and clinically effective, as well as safe, since no detrimental impact was shown on nutrient intake and quality of life. Therefore, apps developed by dietitians may offer a good alternative to patients without access to a dietitian. Despite the differences observed in clinical outcomes among the study groups, no differences were found in energy, nutrient and FODMAP intake. Notably, FODMAP intake varied from 4 to 6 g/d which is lower than previous studies reporting 10–18 g/d in patients advised to follow a low FODMAP diet.28,50 This could be attributed to underreporting as demonstrated by low energy intakes 1552–1713 kcal/d across study groups. The observed improvement in clinical outcomes following dietitian-led consultations is not attributed to lower FODMAP intakes, but could rather be attributed to the additional interaction, discussions, guidance and support patients receive during dietitian-led consultations. Indeed, the vast majority of patients with IBS report their ideal expectations from healthcare professionals are listening, providing support and hope, and demonstrating empathy, with studies showing that a positive patient experience with their healthcare professional is associated with better clinical effectiveness.56,57 This was the first study to assess the feasibility and effectiveness of using dietitian-independent education delivery methods of the low FODMAP diet in an RCT using an active comparator that reflects best clinical practice. Validated questionnaires were used to assess clinical outcomes, and prospective 7-day diaries were used to assess dietary intakes. As this was a feasibility study, no sample size calculation was performed and, therefore, the study was not adequately powered to compare effectiveness among the different education delivery methods. Thus, caution is needed in interpreting the results and further adequately powered trials are warranted, which this feasibility study now justifies. Another limitation is the lack of blinding, which could have resulted in subject and expectation bias, especially if the group preferences reported by patients at follow-up already existed at baseline.33 In addition, fewer booklet group patients (64%) reported English as their first language, compared to over 90% for the app and dietitian groups. Given that the effectiveness of the booklets would rely on patients' understanding of the written content, it may be possible that patients in this group whose first language was not English may have found the content of the booklets more difficult to interpret. However, all patients reported being able to read and understand English before participating in the trial. In addition, there was a vast difference in the contact time between patients and researchers among the study groups, which may have impacted the findings. However, this time variance was part of the pragmatic study design to mimic real-world practice when patients are provided with booklets alone versus apps alone versus dietetic consultations. For the dietary analysis, there is lack of information on the FODMAP content for some food products and, therefore, the FODMAP content of similar foods was used to calculate FODMAP intake when needed. However, a standardized approach was followed for data entry using pre-specified assumption criteria to eliminate inter-group differences. In addition, underreporting of food intake, as demonstrated by the reported daily energy intake, would have resulted in underreporting of all nutrients and FODMAP intakes reported in the current study. Finally, 84% of patients were females and 77% had a university degree which may limit the generalizability of the results. More patients reported adequate symptom relief in the dietitian group (12, 80%) compared to the booklet group (7, 39%; p = 0.026) at follow-up (Table 4). There was a significant difference in change in IBS-SSS across the three groups (p = 0.048); a post hoc analysis showed a greater reduction in patients receiving dietary advice from a dietitian (mean −153, SD 90) compared to the booklet (mean −90, SD 56; p = 0.043). There was a significant difference in the “Affecting life” IBS-SSS sub-score (p = 0.047), with IBS affecting patients' life to a greater degree in the booklet group compared to the dietitian group (mean 44, SEM 4 vs. mean 27, SEM 5; p = 0.044) (Table 4). Incomplete evacuation was also significantly different among the three groups (p = 0.031), with this symptom being greater in the booklet group compared to the dietitian group (mean 1.7, SEM 0.1 vs. mean 1.2, SEM 0.1; p = 0.028). However, no difference was reported for adequate symptom relief, change in IBS-SSS score, degree by which IBS affected patients' life, and symptoms of incomplete evacuation between the app group and the booklet group, and between the app group and the dietitian group (Table 4). Note: Adequate relief of symptoms and achieving minimally clinically important difference were assessed using Chi-square tests; dichotomous data within a row that do not share the same superscript letter are significantly different. Changes in IBS-SSS and IBS-QoL scores were assessed using one-way ANOVA. All other variables were assessed using ANCOVA with baseline values as covariates. Post hoc correction not performed as ANOVA/ANCOVA not significant. Data available for 16/19 patients only in the booklet group as two did not return the 7-day stool, symptom, and food diary and one dropped out. No difference was found between the three groups for severity of individual gut symptoms, IBS-QoL, stool frequency, and stool consistency (Table 4). No differences were found between groups for intakes of energy, nutrients, or FODMAPs at follow-up (Table 5). Note: Data are presented as estimated marginal mean (SEM) and groups were compared using ANCOVA with baseline values as a covariate. Abbreviation: AOAC, Association of Official Analytical Chemists. Data available for 16 out of 19 patients only in the booklet group as two did not return the 7-day stool, symptom, and food diary and one dropped out. Recruitment rate was 2.4 patients/month. In Phase 1 (directly through GPs), it was 1.7 patients/month (12 patients randomized within 7 months), in Phase 2 (through GPs, and a telephone triage clinic at Guy's and St Thomas' NHS Foundation Trust) it was 1.5 patients/month (9 patients randomized within 6 months), and in Phase 3 it was 3.8 patients/month (30 patients randomized within 8 months). In Phase 3 (inclusion of patients with IBS, functional diarrhea, or functional bloating), 53% (16/30) were recruited from primary care and 47% (14/30) from secondary care. Of those recruited in Phase 3, 37% (11/30) had IBS, 57% (17/30) had functional bloating, and 7% (2/30) had functional diarrhea. The mean retention rate was 48 out of 51 (94%) with one drop-out per group (retention per group: 18 out of19 (95%) booklet, 16 out of 17 (94%) app, 14 out of 15 (93%) dietitian). The reasons for discontinuation were: 2 were lost to follow-up (1 booklet, 1 app) and 1 commenced antibiotics (dietitian). In terms of the “adequate relief” global symptom question, most patients agreed or strongly agreed they understood this question (38 out of 48, 79%) and found it easy to answer (39 out of 48, 81%), with no difference among the three groups (p = 0.848 and p = 0.306, respectively). Significantly more patients reported a preference to have received a different education delivery method in the booklet group (15 out of 18, 83%) compared with those in the app (7 out of 16, 44%), and dietitian groups (2 out of 14, 14%; p < 0.001), while no significant difference was found between the app and the dietitian groups. Significantly more patients strongly agreed that they were “able to implement the low FODMAP diet” in the dietitian group (9 out of 14, 64%) compared with the booklet (1 out of 18, 6%), and app groups (2 out of 15, 13%; p = 0.003) (Table 2). No patients in the booklet group strongly agreed that “the education delivery method received enabled me to self-manage without further support,” compared to 7 out of 14 (50%) in the dietitian group (p = 0.007). Similarly, significantly more patients strongly agreed they “would recommend this service to a family member or friend” in the dietitian group (11 out of 14, 85%) compared to the booklet group (5 out of 18, 28%), but not compared to the app group (app, 7 out of 16, 44%; p = 0.021) (Table 2). Significantly fewer patients strongly agreed it was appropriate for GPs to recommend the corresponding education delivery method in the booklet group (6 out of 18, 33%) compared with the dietitian (12 out of 14, 86%), but not compared with the app (10 out of 16, 63%; p = 0.047). There was a significant difference in the Education Method Usability Scale among the three groups (p = 0.004). Particularly, a significantly lower usability score was reported in the booklet group (mean 73, SD 16) compared with the dietitian (mean 90, SD 9; p = 0.008), as well as between the app (mean 73, SD 18) and the dietitian groups (p = 0.010), while no difference was found between the booklet and app groups (p = 1.000). Note: All values are n (%), unless stated. Data within each column within each outcome that do not share the same subscript letter are significantly different. Data available for 15 out of 17 patients in the mobile app group since one did not answer this question and one dropped out. Fisher's exact test p values, those in bold are statistically significant. A significantly higher proportion of patients disagreed that “food labelling is adequate to confidently choose suitable foods” in the app group (9 out of 16, 56%) compared with those in the booklet group (3 out of 18, 17%; p = 0.015), but not compared to the dietitian group (dietitian: 3 out of 15, 21%) (Table 3). Significantly more patients had a very good “current knowledge and understanding” of the low FODMAP diet in the dietitian group (4 out of 14, 29%) compared with the booklet group (0 out of 18, 0%; p = 0.043), but not with the app group (2 out of 16, 13%). Overall, 44 (92%) of all patients reported to have followed the diet for at least 75% of the time (booklet: 15 out of 18, 83%; app, 15 out of 16, 94%, dietitian: 14 out of 14, 100%), with no significant differences between groups (p = 0.817). Note: Data are n (%). Fisher's exact test p values. Data within each column within each outcome that do not share the same subscript letter are significantly different. Seventy-eight patients were screened for the study, of which 51 were randomized to one of the education delivery methods for the low FODMAP diet (Figure 1). Of the 51 patients, 24 (47%) had diarrhea-predominant IBS, 8 (16%) had mixed-type IBS, 17 (33%) had functional bloating, and 2 (4%) had functional diarrhea. Demographic and baseline characteristics of study participants are summarized in Table 1. Note: Data are mean (SD), unless stated. One-way ANOVA test. Fisher's exact test. Recruitment rate was 2.4 patients/month. In Phase 1 (directly through GPs), it was 1.7 patients/month (12 patients randomized within 7 months), in Phase 2 (through GPs, and a telephone triage clinic at Guy's and St Thomas' NHS Foundation Trust) it was 1.5 patients/month (9 patients randomized within 6 months), and in Phase 3 it was 3.8 patients/month (30 patients randomized within 8 months). In Phase 3 (inclusion of patients with IBS, functional diarrhea, or functional bloating), 53% (16/30) were recruited from primary care and 47% (14/30) from secondary care. Of those recruited in Phase 3, 37% (11/30) had IBS, 57% (17/30) had functional bloating, and 7% (2/30) had functional diarrhea. The mean retention rate was 48 out of 51 (94%) with one drop-out per group (retention per group: 18 out of19 (95%) booklet, 16 out of 17 (94%) app, 14 out of 15 (93%) dietitian). The reasons for discontinuation were: 2 were lost to follow-up (1 booklet, 1 app) and 1 commenced antibiotics (dietitian). In terms of the “adequate relief” global symptom question, most patients agreed or strongly agreed they understood this question (38 out of 48, 79%) and found it easy to answer (39 out of 48, 81%), with no difference among the three groups (p = 0.848 and p = 0.306, respectively). Significantly more patients reported a preference to have received a different education delivery method in the booklet group (15 out of 18, 83%) compared with those in the app (7 out of 16, 44%), and dietitian groups (2 out of 14, 14%; p < 0.001), while no significant difference was found between the app and the dietitian groups. Significantly more patients strongly agreed that they were “able to implement the low FODMAP diet” in the dietitian group (9 out of 14, 64%) compared with the booklet (1 out of 18, 6%), and app groups (2 out of 15, 13%; p = 0.003) (Table 2). No patients in the booklet group strongly agreed that “the education delivery method received enabled me to self-manage without further support,” compared to 7 out of 14 (50%) in the dietitian group (p = 0.007). Similarly, significantly more patients strongly agreed they “would recommend this service to a family member or friend” in the dietitian group (11 out of 14, 85%) compared to the booklet group (5 out of 18, 28%), but not compared to the app group (app, 7 out of 16, 44%; p = 0.021) (Table 2). Significantly fewer patients strongly agreed it was appropriate for GPs to recommend the corresponding education delivery method in the booklet group (6 out of 18, 33%) compared with the dietitian (12 out of 14, 86%), but not compared with the app (10 out of 16, 63%; p = 0.047). There was a significant difference in the Education Method Usability Scale among the three groups (p = 0.004). Particularly, a significantly lower usability score was reported in the booklet group (mean 73, SD 16) compared with the dietitian (mean 90, SD 9; p = 0.008), as well as between the app (mean 73, SD 18) and the dietitian groups (p = 0.010), while no difference was found between the booklet and app groups (p = 1.000). Note: All values are n (%), unless stated. Data within each column within each outcome that do not share the same subscript letter are significantly different. Data available for 15 out of 17 patients in the mobile app group since one did not answer this question and one dropped out. Fisher's exact test p values, those in bold are statistically significant. A significantly higher proportion of patients disagreed that “food labelling is adequate to confidently choose suitable foods” in the app group (9 out of 16, 56%) compared with those in the booklet group (3 out of 18, 17%; p = 0.015), but not compared to the dietitian group (dietitian: 3 out of 15, 21%) (Table 3). Significantly more patients had a very good “current knowledge and understanding” of the low FODMAP diet in the dietitian group (4 out of 14, 29%) compared with the booklet group (0 out of 18, 0%; p = 0.043), but not with the app group (2 out of 16, 13%). Overall, 44 (92%) of all patients reported to have followed the diet for at least 75% of the time (booklet: 15 out of 18, 83%; app, 15 out of 16, 94%, dietitian: 14 out of 14, 100%), with no significant differences between groups (p = 0.817). Note: Data are n (%). Fisher's exact test p values. Data within each column within each outcome that do not share the same subscript letter are significantly different. More patients reported adequate symptom relief in the dietitian group (12, 80%) compared to the booklet group (7, 39%; p = 0.026) at follow-up (Table 4). There was a significant difference in change in IBS-SSS across the three groups (p = 0.048); a post hoc analysis showed a greater reduction in patients receiving dietary advice from a dietitian (mean −153, SD 90) compared to the booklet (mean −90, SD 56; p = 0.043). There was a significant difference in the “Affecting life” IBS-SSS sub-score (p = 0.047), with IBS affecting patients' life to a greater degree in the booklet group compared to the dietitian group (mean 44, SEM 4 vs. mean 27, SEM 5; p = 0.044) (Table 4). Incomplete evacuation was also significantly different among the three groups (p = 0.031), with this symptom being greater in the booklet group compared to the dietitian group (mean 1.7, SEM 0.1 vs. mean 1.2, SEM 0.1; p = 0.028). However, no difference was reported for adequate symptom relief, change in IBS-SSS score, degree by which IBS affected patients' life, and symptoms of incomplete evacuation between the app group and the booklet group, and between the app group and the dietitian group (Table 4). Note: Adequate relief of symptoms and achieving minimally clinically important difference were assessed using Chi-square tests; dichotomous data within a row that do not share the same superscript letter are significantly different. Changes in IBS-SSS and IBS-QoL scores were assessed using one-way ANOVA. All other variables were assessed using ANCOVA with baseline values as covariates. Post hoc correction not performed as ANOVA/ANCOVA not significant. Data available for 16/19 patients only in the booklet group as two did not return the 7-day stool, symptom, and food diary and one dropped out. No difference was found between the three groups for severity of individual gut symptoms, IBS-QoL, stool frequency, and stool consistency (Table 4). No differences were found between groups for intakes of energy, nutrients, or FODMAPs at follow-up (Table 5). Note: Data are presented as estimated marginal mean (SEM) and groups were compared using ANCOVA with baseline values as a covariate. Abbreviation: AOAC, Association of Official Analytical Chemists. Data available for 16 out of 19 patients only in the booklet group as two did not return the 7-day stool, symptom, and food diary and one dropped out. Clinical and dietary outcomes were measured at baseline and follow-up. The “adequate relief” global symptom question (“Did you have adequate relief of your functional bowel symptoms over the last 7 days”) was completed.33 The Gastrointestinal Symptom Rating Scale (GSRS) was completed daily over 7 days to assess the severity (0 = absent, 1 = mild, 2 = moderate, 3 = severe) of cardinal symptoms, such as abdominal pain, bloating, and flatulence.34 Stool frequency and consistency were recorded using the Bristol Stool Form Scale through a 7-day stool output diary.35 Stool consistency was reclassified into normal (Bristol Stool Form types 3, 4, or 5), loose (Bristol Stool Form types 6 or 7), or hard (Bristol Stool Form types 1 or 2) as previously reported.36 Global and individual symptoms were also measured via the IBS Symptom Scoring System (IBS-SSS).37 The number (percentage) of people achieving a minimal clinically important difference a 50-point reduction in IBS-SSS score was calculated to allow meaningful interpretation of score change over time.37 The disease-specific IBS-QoL questionnaire was used to assess quality of life.38 Dietary and FODMAP intake was measured using a paper-based 7-day unweighed food and drink diary at baseline and follow-up. The food and drink diaries were checked for completeness by a dietitian at each study visit and additional information was requested by participants when needed. Nutrient intake was assessed using Nutritics Professional Nutrition Analysis software (Nutritics v3.74, Dublin, Ireland), and FODMAP intake was assessed using a bespoke database (Monash University, Melbourne, Australia). Patients were counseled regarding the low FODMAP diet in a one-to-one consultation with the dietitian who provided tailored and detailed information on the low FODMAP diet to match patients' individual needs, in line with usual clinical practice (60 min). During this consultation, patients were also provided with booklets (as used in the booklet group) and/or the app (as used in the app group) to facilitate the consultation in order to mirror a “real-life” dietetic consultation where additional materials are frequently offered to patients based upon the evaluation of the dietitian and patients' needs and will. Patients were asked to download the FoodMaestro FODMAP app (FoodMaestro Ltd, UK) onto their smartphone. The app provided information on the low FODMAP diet and contained an algorithm to detect the presence of FODMAPs in ingredient labels on food products and included the following features: comprehensive search function for food products available in the UK that were suitable and unsuitable for a low FODMAP diet; scanning of food product barcodes to check suitability for a low FODMAP diet; consumption moderation warnings for specific foods; and education texts, symptom tracker, and videos on the low FODMAP diet. During the baseline visit, the researcher briefly explained the main features of the app and how to use it (5 min). Patients were asked to familiarize themselves with how to use the app in their own time and follow the low FODMAP diet for 4 weeks. No dietetic advice was offered from the dietitian at this baseline visit or during the intervention period. Patients were given two comprehensive booklets regarding the low FODMAP diet produced by dietitians and which are commonly used in clinical practice across the UK. The first booklet (“Reducing fermentable carbohydrates the low FODMAP way”) comprised 36 pages and describes the mechanisms by which FODMAPs induce gut symptoms and provides lists of foods that are suitable and unsuitable during the low FODMAP diet. The second booklet (“Suitable products for the low FODMAP diet”) comprises 56 pages and contains a comprehensive list of food products found in UK supermarkets that are suitable for the low FODMAP diet, some low FODMAP recipes and low FODMAP tips to facilitate appropriate food choice. During the baseline visit, the researcher briefly explained the content to be found in each booklet (2 min). Patients were asked to read the booklets thoroughly in their own time and follow the low FODMAP diet for 4 weeks. No dietetic advice was offered from the dietitian at the baseline visit or during the intervention period. Participants were not advised to avoid downloading any FODMAP-related apps, in an effort to adopt a pragmatic study design that reflects real-world practice and patient experience following the provision of this education delivery method. Participants were not advised to avoid seeking further information from any other sources, but neither were they encouraged to. Briefly, FODMAP restriction requires the avoidance of foods high in fructans (e.g., wheat, rye) galacto-oligosaccharides (e.g., pulses), polyols (e.g., apple, sweeteners), lactose (e.g., milk), and excess fructose (e.g., honey). The low FODMAP diet involves using alternative low FODMAP grains, fruit, vegetables, dairy, and nondairy alternatives.26 Previous research indicates that 4 weeks of FODMAP restriction is long enough for the low FODMAP diet to significantly improve functional gut symptoms.27,28 All patients were provided with information on how to follow the low FODMAP diet for 4 weeks using different education delivery methods (booklet alone; app alone; dietitian). Patients were given two comprehensive booklets regarding the low FODMAP diet produced by dietitians and which are commonly used in clinical practice across the UK. The first booklet (“Reducing fermentable carbohydrates the low FODMAP way”) comprised 36 pages and describes the mechanisms by which FODMAPs induce gut symptoms and provides lists of foods that are suitable and unsuitable during the low FODMAP diet. The second booklet (“Suitable products for the low FODMAP diet”) comprises 56 pages and contains a comprehensive list of food products found in UK supermarkets that are suitable for the low FODMAP diet, some low FODMAP recipes and low FODMAP tips to facilitate appropriate food choice. During the baseline visit, the researcher briefly explained the content to be found in each booklet (2 min). Patients were asked to read the booklets thoroughly in their own time and follow the low FODMAP diet for 4 weeks. No dietetic advice was offered from the dietitian at the baseline visit or during the intervention period. Participants were not advised to avoid downloading any FODMAP-related apps, in an effort to adopt a pragmatic study design that reflects real-world practice and patient experience following the provision of this education delivery method. Participants were not advised to avoid seeking further information from any other sources, but neither were they encouraged to. Patients were asked to download the FoodMaestro FODMAP app (FoodMaestro Ltd, UK) onto their smartphone. The app provided information on the low FODMAP diet and contained an algorithm to detect the presence of FODMAPs in ingredient labels on food products and included the following features: comprehensive search function for food products available in the UK that were suitable and unsuitable for a low FODMAP diet; scanning of food product barcodes to check suitability for a low FODMAP diet; consumption moderation warnings for specific foods; and education texts, symptom tracker, and videos on the low FODMAP diet. During the baseline visit, the researcher briefly explained the main features of the app and how to use it (5 min). Patients were asked to familiarize themselves with how to use the app in their own time and follow the low FODMAP diet for 4 weeks. No dietetic advice was offered from the dietitian at this baseline visit or during the intervention period. Patients were counseled regarding the low FODMAP diet in a one-to-one consultation with the dietitian who provided tailored and detailed information on the low FODMAP diet to match patients' individual needs, in line with usual clinical practice (60 min). During this consultation, patients were also provided with booklets (as used in the booklet group) and/or the app (as used in the app group) to facilitate the consultation in order to mirror a “real-life” dietetic consultation where additional materials are frequently offered to patients based upon the evaluation of the dietitian and patients' needs and will. Initially, IBS patients were recruited from GP practices in Lambeth and Southwark Primary Care Trusts identified at GP clinic appointments, patient database searches at five GP practices and letters sent to notify patients about this study (London, UK, Phase 1). Following slow recruitment in the first 7 months (all GP practices identified participants at clinic appointments; two GP practices sent a total of 460 letters to potentially suitable participants), only 12 patients had been randomized. The protocol was amended to include GP referrals to the dietitian at a local secondary care site (Guy's and St Thomas' NHS Foundation Trust, Phase 2). IBS patients identified during a 15-min telephone triage clinic who were eligible and expressed interest in participating in the study were booked for their first study visit instead of routine dietitian-led education. Finally, to enhance recruitment, the inclusion criteria were broadened to also include patients diagnosed with functional diarrhea or functional bloating based on the Rome IV criteria1 (Phase 3). Inclusion criteria: aged 18+ years; Rome IV criteria for diarrhea-predominant or mixed-type IBS, functional bloating or functional diarrhea1; inadequate relief of functional bowel symptoms; body mass index of >18.5 kg/m2; ability to understand and read English; access to Internet; owning a smartphone with Android or IOS software and ability to download apps. Patients were eligible irrespective of previous knowledge or understanding of the low FODMAP diet in order to represent usual clinical dietetic practice. Exclusion criteria: major medical condition; gastrointestinal disease; history of previous gastrointestinal surgery (except for cholecystectomy and hemorrhoidectomy); Rome IV criteria for constipation-predominant IBS due to limited evidence on the effectiveness of the low FODMAP diet in IBS-C and constipation symptoms1,11; antibiotics in the last 4 weeks; additional specific dietary needs/restrictions (e.g., ketogenic diet), and/or multiple food allergies; pregnancy/lactation. As this was a feasibility study, a formal sample size calculation was not appropriate. For feasibility studies, sample sizes between 2424 and 5025 are recommended. Therefore, for this study, a total sample size of 45 was chosen (15 patients per group). A 12% attrition rate was estimated and the final sample size was 51 patients. An open-label, 3-arm, parallel group, feasibility RCT compared different education delivery methods (written information alone (booklet) vs. app alone (app) vs. one-to-one dietitian-led consultations (dietitian)) of the low FODMAP diet for 4 weeks in patients with DGBI referred from primary and secondary care. The trial was approved by the London-Chelsea Research Ethics Committee (16/LO/1753). It registered at ClinicalTrials.gov (registration number NCT03694223). Initially, IBS patients were recruited from GP practices in Lambeth and Southwark Primary Care Trusts identified at GP clinic appointments, patient database searches at five GP practices and letters sent to notify patients about this study (London, UK, Phase 1). Following slow recruitment in the first 7 months (all GP practices identified participants at clinic appointments; two GP practices sent a total of 460 letters to potentially suitable participants), only 12 patients had been randomized. The protocol was amended to include GP referrals to the dietitian at a local secondary care site (Guy's and St Thomas' NHS Foundation Trust, Phase 2). IBS patients identified during a 15-min telephone triage clinic who were eligible and expressed interest in participating in the study were booked for their first study visit instead of routine dietitian-led education. Finally, to enhance recruitment, the inclusion criteria were broadened to also include patients diagnosed with functional diarrhea or functional bloating based on the Rome IV criteria1 (Phase 3). Inclusion criteria: aged 18+ years; Rome IV criteria for diarrhea-predominant or mixed-type IBS, functional bloating or functional diarrhea1; inadequate relief of functional bowel symptoms; body mass index of >18.5 kg/m2; ability to understand and read English; access to Internet; owning a smartphone with Android or IOS software and ability to download apps. Patients were eligible irrespective of previous knowledge or understanding of the low FODMAP diet in order to represent usual clinical dietetic practice. Exclusion criteria: major medical condition; gastrointestinal disease; history of previous gastrointestinal surgery (except for cholecystectomy and hemorrhoidectomy); Rome IV criteria for constipation-predominant IBS due to limited evidence on the effectiveness of the low FODMAP diet in IBS-C and constipation symptoms1,11; antibiotics in the last 4 weeks; additional specific dietary needs/restrictions (e.g., ketogenic diet), and/or multiple food allergies; pregnancy/lactation. As this was a feasibility study, a formal sample size calculation was not appropriate. For feasibility studies, sample sizes between 2424 and 5025 are recommended. Therefore, for this study, a total sample size of 45 was chosen (15 patients per group). A 12% attrition rate was estimated and the final sample size was 51 patients. Participants attended three study visits with a research dietitian (ED) at King's College London. At the screening visit (Visit 1), eligibility was confirmed, informed consent recorded, and participants completed questionnaires for demographic information, and frequency of internet and smartphone/tablet use. Participants were provided with questionnaires to complete baseline clinical and dietary information. At the baseline visit (Visit 2, Week 0), continued eligibility was confirmed, baseline measures were performed (feasibility, clinical, and acceptability), all of which took approximately 30 min, following which randomization was undertaken. Participants received the intervention to which they were assigned. At the follow-up visit (Visit 3, Week 4), repeat measures of feasibility, clinical, and acceptability outcomes were performed. Briefly, FODMAP restriction requires the avoidance of foods high in fructans (e.g., wheat, rye) galacto-oligosaccharides (e.g., pulses), polyols (e.g., apple, sweeteners), lactose (e.g., milk), and excess fructose (e.g., honey). The low FODMAP diet involves using alternative low FODMAP grains, fruit, vegetables, dairy, and nondairy alternatives.26 Previous research indicates that 4 weeks of FODMAP restriction is long enough for the low FODMAP diet to significantly improve functional gut symptoms.27,28 All patients were provided with information on how to follow the low FODMAP diet for 4 weeks using different education delivery methods (booklet alone; app alone; dietitian). Patients were given two comprehensive booklets regarding the low FODMAP diet produced by dietitians and which are commonly used in clinical practice across the UK. The first booklet (“Reducing fermentable carbohydrates the low FODMAP way”) comprised 36 pages and describes the mechanisms by which FODMAPs induce gut symptoms and provides lists of foods that are suitable and unsuitable during the low FODMAP diet. The second booklet (“Suitable products for the low FODMAP diet”) comprises 56 pages and contains a comprehensive list of food products found in UK supermarkets that are suitable for the low FODMAP diet, some low FODMAP recipes and low FODMAP tips to facilitate appropriate food choice. During the baseline visit, the researcher briefly explained the content to be found in each booklet (2 min). Patients were asked to read the booklets thoroughly in their own time and follow the low FODMAP diet for 4 weeks. No dietetic advice was offered from the dietitian at the baseline visit or during the intervention period. Participants were not advised to avoid downloading any FODMAP-related apps, in an effort to adopt a pragmatic study design that reflects real-world practice and patient experience following the provision of this education delivery method. Participants were not advised to avoid seeking further information from any other sources, but neither were they encouraged to. Patients were asked to download the FoodMaestro FODMAP app (FoodMaestro Ltd, UK) onto their smartphone. The app provided information on the low FODMAP diet and contained an algorithm to detect the presence of FODMAPs in ingredient labels on food products and included the following features: comprehensive search function for food products available in the UK that were suitable and unsuitable for a low FODMAP diet; scanning of food product barcodes to check suitability for a low FODMAP diet; consumption moderation warnings for specific foods; and education texts, symptom tracker, and videos on the low FODMAP diet. During the baseline visit, the researcher briefly explained the main features of the app and how to use it (5 min). Patients were asked to familiarize themselves with how to use the app in their own time and follow the low FODMAP diet for 4 weeks. No dietetic advice was offered from the dietitian at this baseline visit or during the intervention period. Patients were counseled regarding the low FODMAP diet in a one-to-one consultation with the dietitian who provided tailored and detailed information on the low FODMAP diet to match patients' individual needs, in line with usual clinical practice (60 min). During this consultation, patients were also provided with booklets (as used in the booklet group) and/or the app (as used in the app group) to facilitate the consultation in order to mirror a “real-life” dietetic consultation where additional materials are frequently offered to patients based upon the evaluation of the dietitian and patients' needs and will. A computerized random allocation sequence was prepared by a researcher not involved in the study. Patients were randomized in a 1:1:1 ratio to one of the three education delivery methods: booklet alone, app alone, or dietitian. Randomization was stratified by sex. The education delivery method allocation was concealed in an opaque envelope that was only opened after all baseline data had been collected. The trial feasibility outcomes were recruitment and retention rate for each (booklet, app, and dietitian). Recruitment rate was calculated as the total number of patients randomized divided by the study duration to provide a monthly recruitment rate. Retention rate was calculated as the number of patients who completed the study divided by the total number of patients randomized to the whole study, and compared between study groups. Intervention feasibility outcomes related to the education delivery methods and were evaluated at follow-up. Appropriateness, understanding, and satisfaction regarding the assigned education delivery method and perceived fit within the National Health Service (NHS) were assessed by patients via a questionnaire that was developed by the researchers using 5-point Likert scales (1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree). Preference for a specific education delivery method was reported by patients using a dichotomous response (yes/no). Self-management questions were used to rate whether the education delivery method enabled patients “to self-manage their symptoms without further support”, and whether they “would recommend their treatment to a family member or friend who suffers from a functional bowel disorder” via 5-point Likert scales (as above). Patients' understanding of the wording of the “adequate relief” global symptom question (see Clinical and dietary outcomes section) was also rated using a 5-point Likert scale (see above). Acceptability of dietary restriction was assessed at follow-up using a 14-item questionnaire adapted from the nutrition-related quality of life questionnaire.29 Questions considered the impact and challenges of diet on eating environment, travel, meal enjoyment, cost, shopping, and cooking. Data were scored using a 5-point Likert scale (as above). Usability of each education delivery method was measured using the Educational Method Usability Scale, adapted from the System Usability Scale which was developed and validated for evaluating technological systems, including apps.30,31 It consists of 10 questions that use a 5-point Likert scale (as above). The total score ranges from 0 (very difficult to use) to 100 (very easy to use), with scores higher than 68 indicating standard usability levels.32 Clinical and dietary outcomes were measured at baseline and follow-up. The “adequate relief” global symptom question (“Did you have adequate relief of your functional bowel symptoms over the last 7 days”) was completed.33 The Gastrointestinal Symptom Rating Scale (GSRS) was completed daily over 7 days to assess the severity (0 = absent, 1 = mild, 2 = moderate, 3 = severe) of cardinal symptoms, such as abdominal pain, bloating, and flatulence.34 Stool frequency and consistency were recorded using the Bristol Stool Form Scale through a 7-day stool output diary.35 Stool consistency was reclassified into normal (Bristol Stool Form types 3, 4, or 5), loose (Bristol Stool Form types 6 or 7), or hard (Bristol Stool Form types 1 or 2) as previously reported.36 Global and individual symptoms were also measured via the IBS Symptom Scoring System (IBS-SSS).37 The number (percentage) of people achieving a minimal clinically important difference a 50-point reduction in IBS-SSS score was calculated to allow meaningful interpretation of score change over time.37 The disease-specific IBS-QoL questionnaire was used to assess quality of life.38 Dietary and FODMAP intake was measured using a paper-based 7-day unweighed food and drink diary at baseline and follow-up. The food and drink diaries were checked for completeness by a dietitian at each study visit and additional information was requested by participants when needed. Nutrient intake was assessed using Nutritics Professional Nutrition Analysis software (Nutritics v3.74, Dublin, Ireland), and FODMAP intake was assessed using a bespoke database (Monash University, Melbourne, Australia). Baseline characteristics of study participants are presented as mean (SD) for continuous variables, and n (%) for categorical variables. Clinical and dietary outcomes were tested for equality of variances using Levene's test. Continuous data were compared using analysis of covariance (ANCOVA) with baseline measures as a covariate, and data were presented as estimated marginal mean and standard error of the mean.39 When ANCOVA was not applicable (e.g., changes in scores from baseline), one-way ANOVA was used and mean (SD) reported. Post hoc analysis was performed using Bonferroni correction, when applicable. Categorical outcomes were analyzed using chi-squared or Fisher's exact tests and n (%) reported. Missing data were assumed to be missing at random and no imputation was performed. All analyses were performed in the intention-to-treat (ITT) population. p values of <0.05 were considered statistically significant. Disorders of gut–brain interaction (DGBI), also known as functional bowel disorders, are characterized by predominant symptoms or signs of abdominal pain, bloating, distention, and/or bowel habit abdormalities.1 They include, irritable bowel syndrome (IBS), functional bloating, and functional diarrhea with a worldwide prevalence of 4.1%, 3.5%, and 4.7%,2 respectively, and have been shown to impair patients' health-related quality of life.3 DGBI should be managed mainly in primary care,4 yet they are a leading cause of secondary care referral with increased healthcare costs.5,6 Therefore, DGBI represent a considerable clinical and financial burden for patients and healthcare systems, highlighting the need for new clinical and cost-effective management strategies. Dietary modification is an early cornerstone treatment for DGBI and preferred by most patients.7,8 A systematic review and meta-analysis demonstrated that restriction of a group of fermentable carbohydrates (FODMAPs) improves global IBS symptoms (RR 1.54, 95% CI 1.2–2.0), and is recommended in guidelines.4,9–12 The majority of evidence on the effectiveness of the low FODMAP diet focus indeed on IBS, while few studies also exist on functional dyspepsia.9,13 However, due to the overlapping pathophysiology, mechanisms and symptoms across various DGBI, the low FODMAP diet is recommended also in several other DGBIs in clinical practice (e.g., functional bloating).13 Dietary guidelines recommend that low FODMAP education should only be provided by a healthcare professional with expertise in dietary management (i.e., dietitian) due to the complexity of the diet.4,8,12,14 However, the unprecedented demand for dietitians to advise on the low FODMAP diet has created challenges to delivering on this recommendation.15 First, not all healthcare centers have access to a dietitian. Second, clinical capacity of dietetic services is limited and waiting times can extend to years for new referrals.16 Given this delay, general practitioners (GPs) and clinicians often suggest patients look online or give written dietary information on the low FODMAP diet.17 However, these dietary education delivery methods have never been studied before in terms of their effectiveness in managing DGBI. Furthermore, a qualitative study showed that patients receiving advice on the low FODMAP diet from GPs or gastroenterologists reported poor experiences and difficulty in applying advice in “real life”.17 Written information is commonly used to educate patients on dietary strategies, including the low FODMAP diet; however, if used alone there are concerns such resources may not be clinically effective, lack individualization, and may negatively impact nutrient intake and food-related quality of life.17–19 However, a primary care study of generic IBS management which assessed written information only, a self-help group along with written information or no intervention (control) showed that patients who received written information alone had 60% less GP consultations, reduced symptom severity, and cost £73/patient less compared to controls,20 thus suggesting that written information alone may be a clinically effective method to deliver dietary information. However, another IBS study showed that written information alone was less effective than structured education in improving symptoms and quality of life.21 To date, no study has assessed the clinical effectiveness of written information alone for the delivery of the low FODMAP diet in patients with DGBI. Mobile applications (apps) are also commonly used for dietary education by health care professionals.22 In fact, the need for personalized technologies, including apps, for the management and monitoring of chronic gastrointestinal disorders has been previously highlighted23; however, research on their clinical and cost-effectiveness in the low FODMAP diet remains limited. This study aims to establish the feasibility of undertaking a trial to investigate the clinical and cost-effectiveness of different education delivery methods of the low FODMAP diet in patients with DGBI. Key points A diet low in fermentable oligo-saccharides, di-saccharides, mono-saccharides and polyols (low FODMAP diet) is complex and clinical effectiveness is achieved with dietitian-led education, although dietitian availability in clinical practice varies. Alternative dietitian-independent education delivery methods, such as written information or mobile apps, are needed and were tested in a feasibility randomized controlled trial (RCT). This feasibility RCT showed greater clinical effectiveness in the dietitian-led education group compared with the booklet group, but not compared with the app group, in patients with irritable bowel syndrome (IBS). Booklets were rated the least acceptable education delivery method. Thus, written information alone should not be used in isolation as an education delivery method of the low FODMAP diet. Adequately powered trials are needed to establish appropriate delivery methods of the low FODMAP diet to ensure equal access to effective dietary treatment among patients with IBS. A diet low in fermentable oligo-saccharides, di-saccharides, mono-saccharides and polyols (low FODMAP diet) is complex and clinical effectiveness is achieved with dietitian-led education, although dietitian availability in clinical practice varies. Alternative dietitian-independent education delivery methods, such as written information or mobile apps, are needed and were tested in a feasibility randomized controlled trial (RCT). This feasibility RCT showed greater clinical effectiveness in the dietitian-led education group compared with the booklet group, but not compared with the app group, in patients with irritable bowel syndrome (IBS). Booklets were rated the least acceptable education delivery method. Thus, written information alone should not be used in isolation as an education delivery method of the low FODMAP diet. Adequately powered trials are needed to establish appropriate delivery methods of the low FODMAP diet to ensure equal access to effective dietary treatment among patients with IBS. In this feasibility randomized controlled trial, patients with DGBI requiring the low FODMAP diet were randomized to receive one of the following education delivery methods: booklet, app, or dietitian. Recruitment and retention rates, acceptability, symptoms, stool output, quality of life, and dietary intake were assessed. A diet low in fermentable oligo-saccharides, di-saccharides, mono-saccharides and polyols (low FODMAP diet) is complex and clinical effectiveness is achieved with dietitian-led education, although dietitian availability in clinical practice varies. This study aimed to assess the feasibility of undertaking a trial to investigate the clinical and cost-effectiveness of different education delivery methods of the low FODMAP diet in patients with disorders of gut–brain interaction (DGBI). Funding Information: Eirini Dimidi has received an education grant from Alpro, research funding from the British Dietetic Association, Almond Board of California, the International Nut and Dried Fruit Council and Nestec Ltd and has served as a consultant for Puratos. Miranda C. E. Lomer was the coinventor of the mobile application used in this study was co‐applicant of a research grant from Clasado Biosciences Ltd. Kevin Whelan has received research funding from Almond Board of California, Clasado Biosciences, Danone, and the International Dried Fruit and Nut Council. Kevin Whelan was the coinventor of the mobile application used in this study and the coinventor of a biomarker of IBS and dietary response. Alastair James McArthur and Rachel White report no conflicts of interest. Publisher Copyright: © 2023 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd.
PY - 2023/10
Y1 - 2023/10
N2 - Background: A diet low in fermentable oligo-saccharides, di-saccharides, mono-saccharides and polyols (low FODMAP diet) is complex and clinical effectiveness is achieved with dietitian-led education, although dietitian availability in clinical practice varies. This study aimed to assess the feasibility of undertaking a trial to investigate the clinical and cost-effectiveness of different education delivery methods of the low FODMAP diet in patients with disorders of gut–brain interaction (DGBI). Methods: In this feasibility randomized controlled trial, patients with DGBI requiring the low FODMAP diet were randomized to receive one of the following education delivery methods: booklet, app, or dietitian. Recruitment and retention rates, acceptability, symptoms, stool output, quality of life, and dietary intake were assessed. Key Results: Fifty-one patients were randomized with a recruitment rate of 2.4 patients/month and retention of 48 of 51 (94%). Nobody in the booklet group strongly agreed that this education delivery method enabled them to self-manage symptoms without further support, compared to 7 of 14 (50%) in the dietitian group (p = 0.013). More patients reported adequate relief of symptoms in the dietitian group (12, 80%) compared with the booklet group (7, 39%; p = 0.026), but not when compared to the app group (10, 63%, p > 0.05). There was a greater decrease in the IBS-SSS score in the dietitian group (mean −153, SD 90) compared with the booklet group (mean −90, SD 56; p = 0.043), but not when compared with the app group (mean −120, SD 62; p = 0.595). Conclusions & Inferences: Booklets were the least acceptable education delivery methods. Dietitian-led consultations led to high levels of clinical effectiveness, followed by the app, while the dietitian was superior to booklets alone. However, an adequately powered clinical trial is needed to confirm clinical effectiveness of these education delivery methods.
AB - Background: A diet low in fermentable oligo-saccharides, di-saccharides, mono-saccharides and polyols (low FODMAP diet) is complex and clinical effectiveness is achieved with dietitian-led education, although dietitian availability in clinical practice varies. This study aimed to assess the feasibility of undertaking a trial to investigate the clinical and cost-effectiveness of different education delivery methods of the low FODMAP diet in patients with disorders of gut–brain interaction (DGBI). Methods: In this feasibility randomized controlled trial, patients with DGBI requiring the low FODMAP diet were randomized to receive one of the following education delivery methods: booklet, app, or dietitian. Recruitment and retention rates, acceptability, symptoms, stool output, quality of life, and dietary intake were assessed. Key Results: Fifty-one patients were randomized with a recruitment rate of 2.4 patients/month and retention of 48 of 51 (94%). Nobody in the booklet group strongly agreed that this education delivery method enabled them to self-manage symptoms without further support, compared to 7 of 14 (50%) in the dietitian group (p = 0.013). More patients reported adequate relief of symptoms in the dietitian group (12, 80%) compared with the booklet group (7, 39%; p = 0.026), but not when compared to the app group (10, 63%, p > 0.05). There was a greater decrease in the IBS-SSS score in the dietitian group (mean −153, SD 90) compared with the booklet group (mean −90, SD 56; p = 0.043), but not when compared with the app group (mean −120, SD 62; p = 0.595). Conclusions & Inferences: Booklets were the least acceptable education delivery methods. Dietitian-led consultations led to high levels of clinical effectiveness, followed by the app, while the dietitian was superior to booklets alone. However, an adequately powered clinical trial is needed to confirm clinical effectiveness of these education delivery methods.
KW - dietitians
KW - education
KW - FODMAP diet
KW - irritable bowel syndrome
KW - mobile apps
KW - smartphone apps
UR - http://www.scopus.com/inward/record.url?scp=85165460400&partnerID=8YFLogxK
U2 - 10.1111/nmo.14640
DO - 10.1111/nmo.14640
M3 - Article
C2 - 37480191
AN - SCOPUS:85165460400
SN - 1350-1925
VL - 35
JO - Neurogastroenterology and Motility
JF - Neurogastroenterology and Motility
IS - 10
M1 - e14640
ER -