protocolSection identificationModule nctId: NCT06261229, orgStudyIdInfo id: MURA2022/230, briefTitle: The Effectiveness of Intermittent Fasting and Behavioral Economics Intervention on Weight Control in Obese Patients, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-04-18, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, collaborators name: Health Systems Research Institute, descriptionModule briefSummary: This study is a parallel randomized controlled trial (RCT). To determine the effect of intermittent fasting, intermittent fasting with behavioral economics, and intensive lifestyle modification on nutritional status; the differences between HOMA-IR, body weight change, and body composition in obese people.Each participant will be randomized to receive the intervention (intermittent fasting, intermittent fasting with behavioral economics, or intensive lifestyle modification.The study protocol will be explained to the eligible participant and informed written consent will be obtained.The total sample size will be 123 participants. Blood and urine samples will be collected at baseline and each follow-up visit including 1-month, 2-months, 6-month, and 12-months, respectively for further study to find out the mechanisms of weight loss, weight regain, and the improvement in the metabolic disease., conditionsModule conditions: Intermittent Fasting, conditions: Weight Loss, conditions: Behavioral Economic, conditions: Obese, conditions: HOMA-IR, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 123, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent fasting, interventions name: Intermittent fasting + Behavioral economic, interventions name: Intensive Lifestyle Modification, outcomesModule primaryOutcomes measure: HOMR-IR (index), primaryOutcomes measure: Body mass index (kg/m^2), secondaryOutcomes measure: FBS (mg/dl), secondaryOutcomes measure: HbA1C (%), secondaryOutcomes measure: Albumin (g/L), secondaryOutcomes measure: Creatinine (mg/dL), secondaryOutcomes measure: Alanine transaminase (ALT) U/L, secondaryOutcomes measure: Aspartate transaminase (AST) U/L, secondaryOutcomes measure: Uric acid (mg/dL), secondaryOutcomes measure: Total cholesterol (mg/dL), secondaryOutcomes measure: HDL-C (mg/dL), secondaryOutcomes measure: LDL-C (mg/dL), secondaryOutcomes measure: Triglycerides (mg/dL), secondaryOutcomes measure: Blood Urea Nitrogen (BUN) (mg/dL), secondaryOutcomes measure: Urine albumin-creatinine ratio (UACR) (mg/g), secondaryOutcomes measure: Energy from food (kilocalories), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mahidol University, city: Ratchathewi, state: Bangkok, zip: 10400, country: Thailand, geoPoint lat: 13.759, lon: 100.53358, hasResults: False