The MIND-GUT Digital Pilot Intervention Study

NCT ID: NCT06374407

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

Objective of the Pilot Study and Study Design:

This 12-week randomized pilot intervention study aims to assess 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 individuals aged 30-50.

Participant Recruitment and Randomization:

Participants aged 30-50, excluding those with specific medical conditions such as psychiatric medication use, food allergies affecting diets, eating disorders, diabetes, polycystic ovary syndrome, sensory deficits, recent antibiotic use, participation in other studies, language limitations, coeliac/inflammatory bowel disease, planned weight management within 3 months, and pregnant/lactating/post-menopausal women, will be recruited for the study. Randomization will be conducted to assign eligible participants to either an intervention or control group using a meal planning smartphone app.

Clinical Assessments:

Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections.

Study Endpoints:

The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity.

Statistical Analyses:

Statistical analyses will evaluate the study feasibility, intervention effects on body weight and mental health changes, and the potential mediating roles of these effects by the gut microbiome.

Implications and Future Plans:

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.

Conditions

Obesity; Depressive Symptoms; Anxiety; Stress; Eating Habit; Dysbiosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control group

The control group comprises participants who do not receive the specific Mind diet intervention but undergo the same procedures as the intervention group, including weighing at the beginning and end of the study, completing identical questionnaires, and providing fecal samples at recruitment and follow-up. They will also use the same meal-planning app as the intervention group.

Group Type: ACTIVE_COMPARATOR

Dietary intervention based on the MIND diet

Intervention Type: 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.

Intervention group

The intervention group consists of participants who receive the Mind diet intervention. Like the control group, they will be weighed at the start and end of the study, answer the same questionnaires, and provide fecal samples at recruitment and follow-up. Additionally, they will use the same meal-planning app as the control group, but their dietary pattern will be based on the Mind diet.

Group Type: EXPERIMENTAL

Dietary intervention based on the MIND diet

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age 30- 50;
• BMI ≥ 30 kg/m2;
• stable physical activity;
• one person per household;
• commitment to full protocol.

Exclusion Criteria

• 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;
• diagnosis of diabetes;
• diagnosis of polycystic ovary syndrome;
• sensory deficits (e.g., COVID-19-induced loss of taste/smell);
• antibiotic use during the latest 3 months;
• participation in another study;
• language understanding limitations (i.e., not able to understand either Swedish or English); - coeliac/inflammatory bowel disease;
• planned weight management program within three months;
• pregnancy;
• lactation;
• menopause.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York - Downstate Medical Center

OTHER

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: collaborator

Kristianstad University

OTHER

Sponsor Role: collaborator

University of Pavia

OTHER

Sponsor Role: collaborator

The Food Scientist AB (Sweden)

UNKNOWN

Sponsor Role: collaborator

University of Skövde

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Tognon

Senior lecturer in public health sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Skövde

Skövde, , Sweden

Countries

Sweden

Facility Contacts

Gianluca Tognon, PhD

Role: primary

Other Identifiers

GT-001

Identifier Type: -

Identifier Source: org_study_id