Health TrialsbyHealthPanel

The MIND-GUT Digital Pilot Intervention Study

ConditionsObesityDepressive SymptomsAnxietyStressEating HabitDysbiosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-50
SponsorUniversity of Skövde

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age 30- 50;

BMI ≥ 30 kg/m2;

stable physical activity;

one person per household;

Disqualifiers

use of psychiatric medications (e.g., serotonin reuptake inhibitors);

use of weight loss medications (GLP-1 receptor agonists);

food allergies affecting adherence to the MIND diet;

diagnosis of eating disorders;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dietary intervention based on the MIND diet

    Behavioral

    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.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Program retention

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.

Time frame
12 weeks
2

Adherence

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.

Time frame
12 weeks
3

Acceptability

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.

Time frame
12 weeks
4

Study effectiveness: change in eating attitudes at follow-up

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.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Skövde

Lead sponsor

State University of New York - Downstate Medical Center

Collaborator

Albert Einstein College of Medicine

Collaborator

Göteborg University

Collaborator

Uppsala University

Collaborator

Kristianstad University

Collaborator

University of Pavia

Collaborator

The Food Scientist AB (Sweden)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: