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.
Age range
30 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Program retention
Timeframe: 12 weeks
Adherence
Timeframe: 12 weeks
Acceptability
Timeframe: 12 weeks
Study effectiveness: change in eating attitudes at follow-up
Timeframe: 12 weeks
Study effectiveness: change in stress levels at follow-up
Timeframe: 12 weeks
Study effectiveness: change in depression symptoms at follow-up
Timeframe: 12 weeks
Study effectiveness: change in anxiety symtoms at follow-up
Timeframe: 12 weeks
Study effectiveness: change in body weight at follow-up
Timeframe: 12 weeks
Study effectiveness: change in % total fat mass at follow-up
Timeframe: 12 weeks
Study effectiveness: change in % visceral fat mass at follow-up
Timeframe: 12 weeks
Study effectiveness: change in waist circumference at follow-up
Timeframe: 12 weeks
Study effectiveness: change in hip circumference at follow-up
Timeframe: 12 weeks
Study effectiveness: change in microbiome variety at follow-up
Timeframe: 12 weeks