protocolSection identificationModule nctId: NCT06302803, orgStudyIdInfo id: NFEC-2024-033, briefTitle: Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial), acronym: INTEREST-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent fasting plus time-restricted eating, interventions name: Calorie restriction, outcomesModule primaryOutcomes measure: Change in body weight over 12 months, secondaryOutcomes measure: Change in body mass index （BMI）, secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in body fat composition meassured by DEXA, secondaryOutcomes measure: Change in liver fat, secondaryOutcomes measure: Change in systolic blood pressure, secondaryOutcomes measure: Change in diastolic blood pressure, secondaryOutcomes measure: Change in concentration of serum triglyceride, secondaryOutcomes measure: Change in concentration of serum total cholesterol, secondaryOutcomes measure: Change in concentration of serum LDL-c, secondaryOutcomes measure: Change in concentration of HbA1c, secondaryOutcomes measure: Change in insulin sensitivity, secondaryOutcomes measure: Change in β cell function, secondaryOutcomes measure: Change in arterial stiffness measured by pulse wave velocity, secondaryOutcomes measure: Change in depression score measured by the Patient Health Questionnaire-9, secondaryOutcomes measure: Change in quality of sleep score measured by the Pittsburgh sleep quality index, secondaryOutcomes measure: Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang Hospital of Southern Medical University, city: Guangzhou, state: Guangdong, zip: 510515, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False