The primary objective of this study is to compare the effectiveness of two app-based interventions on diet quality and perceived stress compared to standard care.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
- Life style intervention
N.a.
Outcome measures
Primary outcome
<p>The main study parameters are diet quality and perceived stress levels. </p>
Secondary outcome
<p>The secondary objectives investigate the effect on IBS-related symptoms and the usability of the app-based interventions. </p>
Background summary
Irritable bowel syndrome (IBS) is a prevalent disorder of the gut-brain interaction affecting 4–6% of the global population. Studies show that 85% of IBS patients indicate certain foods that exacerbate gastrointestinal complaints, and 90% of IBS patients avoid these foods, such as gas-forming vegetables, dairy products, fat-rich items, sparkling soda, apples, and bread. Without professional guidance from a dietician and proper substitutions, this can lead to lower diet quality with possible long-term health consequences. To the best of our knowledge, there is a lack of (digital) support to improve diet quality for this target group and tailored to their perspectives and needs. Therefore, earlier research of the overall project mapped the perspectives and preferences of IBS patients regarding (digital) dietary interventions and guidance and found that they prefer personalized dietary advice and guidance in adjusting their diet (i.e., healthy alternatives for personal trigger foods). This study aims to examine the effect of the developed personalized dietary support app on dietary quality and a personalized stress management app on stress levels, with a secondary aim of assessing its effects on IBS-related symptoms and assessing the usability of these mobile app interventions.
Study objective
The primary objective of this study is to compare the effectiveness of two app-based interventions on diet quality and perceived stress compared to standard care.
Study design
The DIGEST study is a pilot study with a randomized controlled design consisting of three study arms of each 20 participants with a total duration of eight weeks. 60 participants with IBS (based on Rome IV criteria), aged 18 and 65 years, who already identified their trigger foods, will be recruited online through patient organizations for IBS, Wageningen University & Research, and Maastricht University Medical Center+.
Intervention
One group receives an intervention with a mobile application, which focus on personal dietary support and an informational brochure with general stress management support. The second group receives an intervention with a mobile application which focuses on personal stress management support and an informational brochure with general dietary support. The third group receives standard care, which includes an informational brochure with general dietary support and general stress management support.
Study burden and risks
Participation in this study has practically no adverse effects. The only requirement is that participants make use of the intervention offered. As most participants are expected to enroll due to their need for support with their diet or stress management, the time commitment will be proportionate to the potential benefits they will experience. Participants will also be free to withdraw from the study at any time, for any reason, with no consequences. It is possible that the participant does not receive the desired intervention. That is why, after the study, participants are offered to receive the intervention of their choice.
M. van Alst
Stippeneng 4
Wageningen 6708 WE
Netherlands
+31642817084
michelle.vanalst@wur.nl
M. van Alst
Stippeneng 4
Wageningen 6708 WE
Netherlands
+31642817084
michelle.vanalst@wur.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a potential subject must meet all of the following criteria:
- IBS diagnosis using Rome IV-criteria;
- Between 18 and 65 years old;
- Must have already identified which foods trigger their symptoms after completing an elimination diet;
- In possession of a smartphone that can access the internet (Wi-Fi or internet plan);
- In possession of an e-mail address.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Other gastrointestinal disorders and/or proven food allergies;
- No literacy in Dutch (not able to speak and read Dutch);
- Visually impaired;
- Being pregnant or in the lactation period;
- Participation in another human trial;
- Currently employed at the Division of Human Nutrition and Health;
- Legally incompetent;
- Not willing to sign the informed consent.
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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Research portal | NL-009307 |