Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT06254508
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Online Exercise Program and Dietary Advice (FITT-online) for Children and Adolescents With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2024-01-26', 'studyFirstSubmitQcDate': '2024-02-03', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI', 'timeFrame': '16, 32, 52, 104 weeks', 'description': 'Reduction in body mass index (the body mass \\[kg\\] divided by the square of the body height \\[m\\])'}], 'secondaryOutcomes': [{'measure': 'Dietary habits', 'timeFrame': '16, 32, 52, 104 weeks', 'description': 'Change in dietary habits assessed by food frequency questionaire (2015 CHNS)'}, {'measure': 'AE', 'timeFrame': '16, 32, 52, 104 weeks', 'description': 'Adverse events during active intervention by questionaire and healthcare records according to local regulations (PMID: 34327433)'}, {'measure': 'Uric acid', 'timeFrame': '16, 32 weeks', 'description': 'Reduction in serum uric acid levels'}, {'measure': 'Tch', 'timeFrame': '16, 32 weeks', 'description': 'Reduction in serum total cholesterol'}, {'measure': 'LDL-c', 'timeFrame': '16, 32 weeks', 'description': 'Reduction in serum low density lipoprotein cholesterol'}, {'measure': 'HbA1c', 'timeFrame': '16, 32 weeks', 'description': 'Reduction in glycated hemoglobin'}, {'measure': 'HOMA-IR', 'timeFrame': '16, 32 weeks', 'description': 'Reduction in this surrogate marker of beta-cell function and insulin resistance (IR) from basal (fasting) glucose and concentrations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This controlled clinical trial aims to compare the effects of an online program that includes exercise guided by the FITT-VP principle and dietary advice, conducted by fitness coaches, in children and adolescents with obesity with a control group that will be enrolled in conventional in-clinic nutrition and exercise advice. All participants will be monitored for 8 months during the active intervention, and followed by 16 months of observation.\n\nThe study will evaluate the following parameters between groups: BMI, anthropometry, blood biochemistry panel (ALT/AST, lipids, uric acid, HOMA-IR, HbA1c), food frequency questionaire, household survey, satisfaction survey, and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Simple obesity: Body mass index (BMI) between +2SD and +3SD of the reference range: based on the "Standard Deviation Curve of BMI for Children 0-18 Years of Age in China", which was developed by the Physical Development Survey of Children in Nine Provinces/Cities in 2005;\n2. Not participating in other weight management programs currently or in the 3 months prior to the study;\n3. Accepts to participate and signs informed consent.\n\nExclusion Criteria:\n\n1. Currently taking or planning to take medications or interventions that affect body weight during the study period (32 weeks)\n2. Obesity caused by other medical conditions. For example, hypothalamic-pituitary disease, hypothyroidism, growth hormone deficiency, Cushing\'s syndrome, obesity-related syndromes.\n3. Comorbidity with other chronic diseases. E.g. psychiatric diseases, respiratory diseases, gastrointestinal diseases, rheumatic diseases, hepatic and renal insufficiency, chronic infectious diseases;\n4. Presence of abnormal laboratory values at the time of screening indicating a clinically significant underlying disease or condition that may prevent the subject from participating in the study; or presence of abnormalities in the following laboratory tests: alanine aminotransferase (ALT) greater than 5 times the upper limit of normal, serum creatinine (Scr) greater than 1.5 times the upper limit of normal.\n5. Contraindications to physical exercise or exercise-related risks. For example, history of asthma, history of hypoglycemia/diabetes, history of heart disease, history of cardiovascular disease, fracture/surgery/planned surgery within the last 1 year, psychomotor retardation, motor system defects/disabilities, previous history of exercise intolerance;'}, 'identificationModule': {'nctId': 'NCT06254508', 'acronym': 'FITT-online', 'briefTitle': 'Online Exercise Program and Dietary Advice (FITT-online) for Children and Adolescents With Obesity', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'The Effectiveness of an Online FITT-VP Principle Based Exercise Program and Dietary Guidance in the Management of Childhood and Adolescent Obesity.', 'orgStudyIdInfo': {'id': 'FITT-online-[2023]-251'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FITT to CON', 'description': 'Online program that includes exercise guided by the FITT-VP principle and dietary advice for 16 weeks, followed by conventional in-clinic nutrition and exercise advice and self-control for 16 weeks.', 'interventionNames': ['Behavioral: Online program that includes exercise guided by the FITT-VP principle and dietary advice', 'Behavioral: Conventional in-clinic nutrition and exercise advice and self-control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CON to FITT', 'description': 'Conventional in-clinic nutrition and exercise advice and self-control for 16 weeks, followed by online program that includes exercise guided by the FITT-VP principle and dietary advice for 16 weeks.', 'interventionNames': ['Behavioral: Online program that includes exercise guided by the FITT-VP principle and dietary advice', 'Behavioral: Conventional in-clinic nutrition and exercise advice and self-control']}], 'interventions': [{'name': 'Online program that includes exercise guided by the FITT-VP principle and dietary advice', 'type': 'BEHAVIORAL', 'description': "1. Week 1: Children received 2 sessions of exercise initiation and 1 session of small group exercise training (45 minutes) with 4\\~6 peers.\n2. Weeks 2 to 16: 3 small group exercise sessions per week (45 minutes, 4-6 peers) of moderate-to-vigorous physical activity (MVPA). Effective exercise time was assessed by the time subjects reached the heart rate corresponding to the exercise intensity (64-95% of maximal heart rate), as measured by the instantaneous heart rate recorded during each exercise session. The type of exercise was a combination of aerobic, resistance, and flexibility exercises (time ratio 2.5:1:1).\n3. Dietary guidance was provided concurrently during the 16-week intervention period: by establishing a WeChat group for caregivers and uploading daily pictures of the day's food to the group, the group's health coaches provided daily targeted dietary guidance.", 'armGroupLabels': ['CON to FITT', 'FITT to CON']}, {'name': 'Conventional in-clinic nutrition and exercise advice and self-control', 'type': 'BEHAVIORAL', 'description': 'Physicians provide instructions on exercise and nutrition (total daily calorie intake) for the patients to conduct self-control for 16 weeks.', 'armGroupLabels': ['CON to FITT', 'FITT to CON']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Feihong Luo', 'role': 'CONTACT', 'email': 'luofh@fudan.edu.cn', 'phone': '+862164931226'}, {'name': 'Chengjsun Sun', 'role': 'CONTACT', 'email': '0356117@fudan.edu.cn', 'phone': '+862164932107'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Simlab Health Technology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Department of Endocrinology and Inherited Metabolic Diseases', 'investigatorFullName': 'Feihong Luo', 'investigatorAffiliation': "Children's Hospital of Fudan University"}}}}