Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-24 @ 6:55 PM
Study NCT ID:
NCT02482220
Status:
UNKNOWN
Last Update Posted:
2016-05-11
First Post:
2015-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity Program and Energy Intake Control in Obese Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2015-06-19', 'studyFirstSubmitQcDate': '2015-06-25', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in Energy intake in kcal is being assessed', 'timeFrame': 'energy intake will be assessed during 24h during the week before the intervention (T0) and the week after (T1)', 'description': 'daily energy intake will be assessed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pediatric Obesity']}, 'descriptionModule': {'briefSummary': 'Acute exercise of high intensity has been shown to induced nutritional adaptations in obese adolescents. Indeed, several studies have shown that about 30 minutes of intensive exercise (above 70% of the adolescents maximal aerobic capacities) can favor reduced-energy consumption at the following meal with no modification of their appetite feelings. Although it is suggested that chronic physical activity programs can induce energy intake modifications, this has never been clearly studied. The aim of this work is to compare different physical activity programs (low vs. high intensity programs) in terms of energy intake, appetite feelings and appetite-regulating hormones, in obese adolescents.', 'detailedDescription': "After an first medical visit to ensure that the adolescents have the ability to complete the whole study, the participants will have to complete several clinical examinations:\n\n* anthropometric measurements\n* Body composition assessed by DXA\n* Maximal aerobic test\n* Blood samples (appetite-regulating hormones)\n* daily energy intake assessment during a 24h intake exploration.\n\nThe adolescents recruited will then be randomly assigned to one of the two intervention groups:\n\n\\- High Intensity program or moderate intensity program. Those two physical activity programs will last 4-months and will be composed of 3 to 4 exercise sessions per week. The High intensity program will consists in High intensity interval exercises starting at 70% of the adolescents' capacities at the beginning to end around 95%. The moderate intensity program will propose continuous exercises set between 50-65% VO2max.\n\nNo energy intake intervention will be performed.\n\nBy the end of the 4-months intervention, all the clinical examinations performed before the intervention will be repeated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12 to 15 years old adolescents\n* Obese according to international values for BMI\n* Being registered to the national social security insurance\n* no eating disorders\n* no medications\n* metabolic disorders\n\nExclusion Criteria:\n\n* metabolic disorders\n* food disorders\n* physical disability'}, 'identificationModule': {'nctId': 'NCT02482220', 'briefTitle': 'Physical Activity Program and Energy Intake Control in Obese Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Université Blaise Pascal, Clermont-Ferrand'}, 'officialTitle': 'Physical Activity and Energy Intake Control in Obese Adolescents: Effect of Exercise Programs of Various Intensities', 'orgStudyIdInfo': {'id': 'AU 1178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity', 'description': 'in this group, the participants will follow a high intensity physical activity program (High Intensity Interval exercise from 75 to 95% VO2max)', 'interventionNames': ['Behavioral: Physical activity intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate intensity', 'description': 'in this group, the participants will follow a moderate intensity physical activity program (Intensity from 50 to 65% VO2max)', 'interventionNames': ['Behavioral: Physical activity intervention']}], 'interventions': [{'name': 'Physical activity intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['High intensity', 'Moderate intensity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'state': 'Auvergne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David Thivel, PhD', 'role': 'CONTACT', 'email': 'thiveldavid@hotmail.com', 'phone': '0473407679'}, {'name': 'Lore Metz, PhD', 'role': 'CONTACT', 'email': 'lore.Metz@univ-bpclermont.fr', 'phone': '0473407679'}], 'facility': 'AME2P Laboratory', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'David Thivel, PhD', 'role': 'CONTACT', 'email': 'thiveldavid@hotmail.com', 'phone': '0473407679'}, {'name': 'Lore Metz, PhD', 'role': 'CONTACT', 'email': 'Lore.Metz@univ-bpclermont.fr', 'phone': '0473407679'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Blaise Pascal, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, As/Pr, Research scientist', 'investigatorFullName': 'THIVEL David', 'investigatorAffiliation': 'Université Blaise Pascal, Clermont-Ferrand'}}}}