nctId: NCT06374407 id: GT-001 briefTitle: The MIND-GUT Digital Pilot Intervention Study acronym: MINDGUT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-05 date: 2026-12 date: 2024-04-18 date: 2024-04-18 name: University of Skövde class: OTHER name: State University of New York - Downstate Medical Center name: Albert Einstein College of Medicine name: Göteborg University name: Uppsala University name: Kristianstad University name: University of Pavia name: The Food Scientist AB (Sweden) briefSummary: 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. conditions: Obesity conditions: Depressive Symptoms conditions: Anxiety conditions: Stress conditions: Eating Habit conditions: Dysbiosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We plan to randomly assign participants to either the intervention or control group. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Participants will be blinded to their group assignment and will use a smartphone app for meal planning. However, those in the intervention group may have some awareness of their assignment due to specific food choices. Meanwhile, the control group will have access to a variety of foods and recipes, maintaining blinding between the groups regarding their assigned diets, addressing a common challenge in diet intervention studies. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Dietary intervention based on the MIND diet measure: Program retention measure: Adherence measure: Acceptability measure: Study effectiveness: change in eating attitudes at follow-up measure: Study effectiveness: change in stress levels at follow-up measure: Study effectiveness: change in depression symptoms at follow-up measure: Study effectiveness: change in anxiety symtoms at follow-up measure: Study effectiveness: change in body weight at follow-up measure: Study effectiveness: change in % total fat mass at follow-up measure: Study effectiveness: change in % visceral fat mass at follow-up measure: Study effectiveness: change in waist circumference at follow-up measure: Study effectiveness: change in hip circumference at follow-up measure: Study effectiveness: change in microbiome variety at follow-up sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: University of Skövde city: Skövde zip: 54128 country: Sweden name: Gianluca Tognon, PhD role: CONTACT lat: 58.39118 lon: 13.84506 hasResults: False