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NCT Number: NCT06374407

The MIND-GUT Digital Pilot Intervention Study

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.

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Key information

Conditions

Obesity Anxiety Anxiety Disorders Behavior Behavior, Animal Behavioral Symptoms Body Weight Depression Depressive Symptoms Dysbiosis Eating Habit Feeding Behavior Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms Stress

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Skövde

Skövde, 54128, Sweden

Location contact

Gianluca Tognon, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Program retention

    Time frame: 12 weeks

    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.

  2. Adherence

    Time frame: 12 weeks

    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.

  3. Acceptability

    Time frame: 12 weeks

    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.

  4. Study effectiveness: change in eating attitudes at follow-up

    Time frame: 12 weeks

    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.

  5. Study effectiveness: change in stress levels at follow-up

    Time frame: 12 weeks

    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.

  6. Study effectiveness: change in depression symptoms at follow-up

    Time frame: 12 weeks

    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.

  7. Study effectiveness: change in anxiety symtoms at follow-up

    Time frame: 12 weeks

    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.

  8. Study effectiveness: change in body weight at follow-up

    Time frame: 12 weeks

    Comparison of body weight at baseline vs. follow-up

  9. Study effectiveness: change in % total fat mass at follow-up

    Time frame: 12 weeks

    Comparison of body % total fat mass at baseline vs. follow-up

  10. Study effectiveness: change in % visceral fat mass at follow-up

    Time frame: 12 weeks

    Comparison of body % visceral fat at baseline vs. follow-up

  11. Study effectiveness: change in waist circumference at follow-up

    Time frame: 12 weeks

    Comparison of waist circumference at baseline vs. follow-up

  12. Study effectiveness: change in hip circumference at follow-up

    Time frame: 12 weeks

    Comparison of hip circumference at baseline vs. follow-up

  13. Study effectiveness: change in microbiome variety at follow-up

    Time frame: 12 weeks

    Comparison of number and types of species at baseline vs. follow-up.

Sponsors and collaborators

Lead sponsor

University of Skövde

Other

Collaborators

  • Albert Einstein College of Medicine
  • Göteborg University
  • Kristianstad University
  • State University of New York - Downstate Medical Center
  • The Food Scientist AB (Sweden)
  • University of Pavia
  • Uppsala University

Registry information

Official study title

Exploring the Interplay Between Diet, Obesity, Mental Health, and the Gut Microbiome. The MIND-GUT Digital Pilot Intervention Study.

Acronym: MINDGUT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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