[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554514":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intermittent dietary restriction group (ILCD or ICR)","EXPERIMENTAL","Intermittent dietary restriction group will receive ILCD or ICR intervention. ILCD will be conducted as a carbohydrate intake restriction of ≤ 50 g\u002Fday for two consecutive or discontinuous days per week, and ICR will be conducted as a calorie intake restriction of 500-600 kcal\u002Fday for two consecutive or discontinuous days per week.",[13,14],"Behavioral: Intermittent dietary restriction","Behavioral: General health education",{"label":16,"type":17,"description":18,"interventionNames":19},"Health education group","ACTIVE_COMPARATOR","Health education group will receive health education based on Chinese guidelines for school-aged children.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Intermittent dietary restriction","Intermittent dietary restriction will include the ILCD and ICR, which will be self-administered interventions in daily lives. The ILCD intervention will ask participants to restrict carbohydrate intake to ≤ 50 g\u002Fd on two consecutive or discontinuous days per week. The ICR intervention will ask participants to restrict caloric intake to 600 kcal\u002Fd for boys and 500 kcal\u002Fd for girls on two consecutive or discontinuous days per week.\n\nAt baseline, participants will receive face-to-face oral dietary instructions (e.g., principle of dietary restriction, sample menus, food list with macronutrients). Participants will receive the intervention booklets containing dietary advice and sample menus for diet according to the requirements of the dietary intervention.\n\nParticipants will be required to record dietary and physical activity data on a regular basis. The total intervention duration will be 12 months, including a 3-month intervention phase and a 9-month self-maintenance phase.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"General health education","General health education based on dietary and physical activity guidelines for Chinese children and adolescents, will regularly send offline and online promotional materials to participants.",[16,9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Yalan Dou","CONTACT","+86 021 64932921","yldou16@fudan.edu.cn",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Weili Yan","+86 021 64931215","yanwl@fudan.edu.cn",[42],{"facility":5,"status":43,"city":44,"state":26,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Shanghai","China","CN",{"type":48,"coordinates":49},"Point",[50,51],121.45806,31.22222,{"lat":51,"lon":50},[54],{"name":33,"role":34,"phone":26,"phoneExt":26,"email":36},{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100554514","effects-of-intermittent-dietary-restriction-on-cardiometabolic-risk-in-school-aged-children-100554514",false,"NCT06500078","Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children","Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 7-18 years at baseline.\n* At least one of the following cardio-metabolic abnormalities:\n\n  1. Prediabetes (Impaired fasting glucose: 5.6 ≤ fasting blood glucose level ≤ 6.9 mmol\u002FL; or Impaired glucose tolerance: 7.8 ≤ blood glucose level after 2 hours postprandial ≤ 11.0 mmol\u002FL).\n  2. Lipid abnormalities (High-density lipoprotein cholesterol ≤ 1.04 mmol\u002FL; or Low-density lipoprotein cholesterol ≥ 3.37 mmol\u002FL; or Triglycerides ≥ 1.70 mmol\u002FL, or Total cholesterol ≥ 5.18 mmol\u002FL).\n  3. Elevated blood pressure (Systolic\u002Fdiastolic blood pressure consistently higher than the 90th percentile for gender, age, and height; or systolic\u002Fdiastolic blood pressure ≥ 120\u002F80 mmHg).\n\nExclusion Criteria:\n\n* Previously diagnosed with heart failure, severe malnutrition, immune deficiency, liver or kidney disease, cancer, or other diseases deemed unsuitable for participation.\n* Had a history of bariatric surgery.\n* Used weight loss pills or supplements in the last three months.\n* Other situations unsuitable for participation.","ALL","7 Years","18 Years",{"count":68,"type":69},324,"ESTIMATED","INTERVENTIONAL",[72],"NA","This randomized trial aims to evaluate the health-promoting effects of intermittent dietary restrictions, including intermittent low-carbohydrate diet (ILCD) and calorie restriction (ICR), in school-aged children with cardiometabolic risk (CMR) compared with general health education based on dietary and physical activity guidelines for Chinese children.",[75],"Cardiovascular Syndrome, Metabolic",[77,78,79,80],"Intermittent carbohydrate restriction","Intermittent calorie restriction","Cardiometabolic risk","Children","2026-07-02",{"date":83,"type":84},"2026-07-06","ACTUAL",{"date":86,"type":84},"2024-07-13",{"date":88,"type":69},"2027-12-31",{"name":5,"class":6},1]