Clinical trial
The MIND-GUT Digital Pilot Intervention Study
Opening soon · Not applicable · 1 countries · Registry ID NCT06374407
What this study is about
This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations.
Basic eligibility
Full registry criteria
Treatments and study arms
Dietary intervention based on the MIND diet
A 12-week pilot randomized controlled trial (RCT) involving N=126 obese participants (1:1 gender ratio) to assess protocol feasibility, including recruitment, retention, compliance, physical examinations, and gut sample collection. Sample size, calculated by a statistician, expects a 5% body weight change at follow-up (std. dev. 10%). We chose a 12-week duration for this pilot study to allow sufficient time to observe significant changes in both body weight and mental health.
Primary outcomes
Evaluation of participants' continued engagement in the program over time i.e., % of individuals completing the second and third 24h diet recall and % of participants returning to the second visit at the end of the intervention.
Measurement of participants' compliance with the assigned diet and program through 24h recall interviews, assessed comparing reported intake frequencies of each food group with the recommended intake frequencies according to the principles of the MIND diet.
Assessment of participants' experience of the program through qualitative interviews, focusing in particular on: Perception of and experience with the intervention, intervention components (dietary plans, use of the app, etc.), factors influencing participants' engagement, perceived impact on behavior and well-being, interaction with the staff, suggestions for improvement.
Comparison of a score calculated after administration of the EAT-26 questionnaire at baseline vs. follow-up. The EAT-26 comprises three subscales, namely, Dieting, Bulimia and Food Preoccupation, and Oral Control. Higher scores correspond to a worse outcome.
Comparison of PSS-4 questionnaire at baseline vs. follow-up. The PSS total score is calculated by reverse-coding the positive items and summing the scores for all items. The total scores range from 0 to 56, from 0 to 40, and from 0 to 16 for the PSS-14, PSS-10, and PSS-4, respectively. A higher score indicates more perceived stress.
Comparison of PHQ-9 questionnaire at baseline vs. follow-up. The PHQ-9 is a tool to assist clinicians in identifying and diagnosing major depression. It has a maximum score of 27. Higher scores correspond to worst outcomes in terms of depression symtoms.
Comparison of GAD-7 questionnaire at baseline vs. follow-up. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting worst outcomes in terms of anxiety severity.
Comparison of body weight at baseline vs. follow-up
Study locations
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