protocolSection identificationModule nctId: NCT06374407, orgStudyIdInfo id: GT-001, briefTitle: The MIND-GUT Digital Pilot Intervention Study, acronym: MINDGUT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Skövde, class: OTHER, collaborators name: State University of New York - Downstate Medical Center, collaborators name: Albert Einstein College of Medicine, collaborators name: Göteborg University, collaborators name: Uppsala University, collaborators name: Kristianstad University, collaborators name: University of Pavia, collaborators name: The Food Scientist AB (Sweden), descriptionModule 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., conditionsModule conditions: Obesity, conditions: Depressive Symptoms, conditions: Anxiety, conditions: Stress, conditions: Eating Habit, conditions: Dysbiosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: We plan to randomly assign participants to either the intervention or control group., primaryPurpose: TREATMENT, maskingInfo 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, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Dietary intervention based on the MIND diet, outcomesModule primaryOutcomes measure: Program retention, primaryOutcomes measure: Adherence, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Study effectiveness: change in eating attitudes at follow-up, primaryOutcomes measure: Study effectiveness: change in stress levels at follow-up, primaryOutcomes measure: Study effectiveness: change in depression symptoms at follow-up, primaryOutcomes measure: Study effectiveness: change in anxiety symtoms at follow-up, primaryOutcomes measure: Study effectiveness: change in body weight at follow-up, primaryOutcomes measure: Study effectiveness: change in % total fat mass at follow-up, primaryOutcomes measure: Study effectiveness: change in % visceral fat mass at follow-up, primaryOutcomes measure: Study effectiveness: change in waist circumference at follow-up, primaryOutcomes measure: Study effectiveness: change in hip circumference at follow-up, primaryOutcomes measure: Study effectiveness: change in microbiome variety at follow-up, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Skövde, city: Skövde, zip: 54128, country: Sweden, contacts name: Gianluca Tognon, PhD, role: CONTACT, geoPoint lat: 58.39118, lon: 13.84506, hasResults: False