Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT00461994
Status:
COMPLETED
Last Update Posted:
2007-04-18
First Post:
2007-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Exercise and Diet in Weight Loss in Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-04-17', 'studyFirstSubmitDate': '2007-04-17', 'studyFirstSubmitQcDate': '2007-04-17', 'lastUpdatePostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI'}, {'measure': 'BMI-SDS'}, {'measure': 'BODY FAT PERCENTAGE'}, {'measure': 'WAIST AND HIP CIRCUMFERENCES'}], 'secondaryOutcomes': [{'measure': 'BLOOD METABOLIC PROFILE'}, {'measure': 'BLOOD INFLAMATORY MARKERS'}, {'measure': 'GHRELIN AND LEPTIN LEVELS'}, {'measure': 'RESTING ENERGY EXPENDITURE'}, {'measure': 'PSYCHOLOGICAL PARAMETERS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OBESITY', 'CHILDREN', 'METABOLIC PARAMETERS', 'DIET', 'EXERCISE'], 'conditions': ['Pediatric Obesity']}, 'descriptionModule': {'briefSummary': 'A 3-arms randomized prospective intervention study to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI\\> 95th percentile for age and gender. Children were randomly allocated into three groups. The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.\n\nThe total duration of the intervention is 12 weeks followed by a period of 9 months of follow-up. The effects of the different intervention on weight loss and weight maintenance,body composition, on hormonal components that regulate the caloric balance, on metabolic profile and cardiovascular risk factors and on psychological parameters were also determined.', 'detailedDescription': 'A 3-arms randomized prospective intervention study including 161 patients in order to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI\\> 95th percentile for age and gender. The study recruited patients from 2 endocrine clinics.\n\nObjectives:\n\n1. The main aim was to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese children.\n2. Secondary goals were:\n\n 1. To determine the effects of exercise and/or diet on body composition.\n 2. To determine the effects of exercise and/or diet on leptin and ghrelin that play a role in the regulation of energy balance.\n 3. To determine the effects of exercise and/or diet on metabolic profile, cardiovascular risk factors, and inflammatory markers as fasting glucose,insulin and lipid profile,homocysteine ,adiponectin levels,CRP,and IL-6.\n 4. To determine the role of exercise and/or diet on psychological parameters of obese children.\n\nStudy Population\n\nInclusion Criteria\n\n1. Obese preadolescent children 6-11 year-old with BMI\\> 95th percentile for age and gender.\n2. A signed informed consent will be taken from patients and their parents.\n3. Agreement to a follow-up of one year.\n\nExclusion Criteria\n\n1. Cardiac problems (arrhythmia, Congestive heart disease)\n2. Uncontrolled hypertension\n3. Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)\n4. Renal failure\n5. Genetic syndromes associated with obesity\n6. Presence of untreated hypothyroidism\n7. Participation in a clinical study during the last month methods Children fulfilling the inclusion and exclusion criteria were randomly allocated into one of three groups.\n\nThe first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.\n\nOn the first visit of the study, at the end of the intervention (12 weeks) and at the end of the follow-up period (1 year) the following had been checked:\n\nWeight, Height, Body impedance, Waist and hip circumferences, Skin-folds, Blood pressure, Basal Metabolic Rate (evaluated by a metabolic monitor), and blood samples for: Blood count, Liver function, Renal function, Fasting Lipid, glucose and insulin,CRP, IL-6, TSH, free T4, Homocysteine, Adiponectin, Leptin and Ghrelin. Also at these point of time every patient underwent a psychosocial evaluation with life style questioners.\n\nSafety:There were no complications with these modes of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Obese preadolescent children 6-11 year-old with BMI\\> 95th percentile for age and gender.\n2. A signed informed consent will be taken from patients and their parents.\n3. Agreement to a follow-up of one year.\n\nExclusion Criteria:\n\n1. Cardiac problems (arrhythmia, Congestive heart disease)\n2. Uncontrolled hypertension\n3. Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)\n4. Renal failure\n5. Genetic syndromes associated with obesity\n6. Presence of untreated hypothyroidism\n7. Participation in a clinical study during the last month'}, 'identificationModule': {'nctId': 'NCT00461994', 'briefTitle': 'The Role of Exercise and Diet in Weight Loss in Obese Children', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'The Role of Exercise and/or Diet in Weight Loss, and Weight Maintenance in Obese Preadolescent Children', 'orgStudyIdInfo': {'id': 'rmc003189CTil'}}, 'armsInterventionsModule': {'interventions': [{'name': 'diet', 'type': 'BEHAVIORAL'}, {'name': 'exercise', 'type': 'BEHAVIORAL'}, {'name': 'diet and exercise', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '49202', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': "Schneider Children's Medical Center", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Moshe Phillip, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schneider Children Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'D-Cure, Israel', 'class': 'INDUSTRY'}, {'name': 'Soroka University Medical Center', 'class': 'OTHER'}]}}}