Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT03552367
Status:
UNKNOWN
Last Update Posted:
2018-06-11
First Post:
2018-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Structured Exercise Prescription Program in Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-07-14', 'releaseDate': '2022-03-16'}], 'estimatedResultsFirstSubmitDate': '2022-03-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D063766', 'term': 'Pediatric 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'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized open clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-08', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-06-08', 'lastUpdatePostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VO2 max', 'timeFrame': '6 months', 'description': 'Changes in VO2 max as fitness indicator'}, {'measure': 'OGTT', 'timeFrame': '6 months', 'description': 'Oral glucose tolerance test'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': '6 months', 'description': 'BMI zScore'}, {'measure': 'AST', 'timeFrame': '6 months', 'description': 'AST'}, {'measure': 'ALT', 'timeFrame': '6 months', 'description': 'ALT'}, {'measure': 'GGT', 'timeFrame': '6 months', 'description': 'GGT'}, {'measure': 'Leptin', 'timeFrame': '6 months', 'description': 'Leptin'}, {'measure': 'Adiponectin', 'timeFrame': '6 months', 'description': 'Adiponectin'}, {'measure': 'Lean body mass', 'timeFrame': '6 months', 'description': 'Lean body mass'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Children', 'Non-alcoholic fatty acid liver disease', 'Exercise', 'Metabolic syndrome', 'Cardiovascular risk'], 'conditions': ['Obesity', 'Exercise', 'Cardiovascular Risk Factor', 'Liver Diseases', 'Metabolic Syndrome', 'Childhood Obesity']}, 'referencesModule': {'references': [{'pmid': '18055652', 'type': 'BACKGROUND', 'citation': 'Krebs NF, Himes JH, Jacobson D, Nicklas TA, Guilday P, Styne D. Assessment of child and adolescent overweight and obesity. Pediatrics. 2007 Dec;120 Suppl 4:S193-228. doi: 10.1542/peds.2007-2329D.'}, {'pmid': '16812927', 'type': 'BACKGROUND', 'citation': 'American Dietetic Association (ADA). Position of the American Dietetic Association: individual-, family-, school-, and community-based interventions for pediatric overweight. J Am Diet Assoc. 2006 Jun;106(6):925-45. doi: 10.1016/j.jada.2006.03.001.'}, {'pmid': '27084289', 'type': 'BACKGROUND', 'citation': 'Kelley GA, Kelley KS. Exercise and BMI z-score in overweight and obese children and adolescents: protocol for a systematic review and network meta-analysis of randomised trials. BMJ Open. 2016 Apr 15;6(4):e011258. doi: 10.1136/bmjopen-2016-011258.'}, {'pmid': '27792271', 'type': 'BACKGROUND', 'citation': 'Kelley GA, Kelley KS, Pate RR. Exercise and BMI z-score in Overweight and Obese Children and Adolescents: A Systematic Review and Network Meta-Analysis of Randomized Trials. J Evid Based Med. 2017 May;10(2):108-128. doi: 10.1111/jebm.12228.'}, {'pmid': '22634075', 'type': 'BACKGROUND', 'citation': 'Lison JF, Real-Montes JM, Torro I, Arguisuelas MD, Alvarez-Pitti J, Martinez-Gramage J, Aguilar F, Lurbe E. Exercise intervention in childhood obesity: a randomized controlled trial comparing hospital-versus home-based groups. Acad Pediatr. 2012 Jul-Aug;12(4):319-25. doi: 10.1016/j.acap.2012.03.003. Epub 2012 May 26.'}]}, 'descriptionModule': {'briefSummary': 'This controlled clinical trial aims to compare the effects of a multicomponent program that includes structured personalized exercise prescription in children with obesity with a control group that will be enrolled in a multicomponent program without structured personalized exercise prescription. All children will be followed for a period of 6 months.\n\nThe parameters that will be evaluated between groups are physical fitness, anthropometry, metabolic (glucose oral tolerance curve, lipids, HOMA-IR, ISI-MATSUDA), early cardiovascular damage, inflammatory biomarkers, anxiety and depression scores, and allelic variants related to physical fitness.', 'detailedDescription': 'This controlled clinical trial aims to compare the effects of a multicomponent program that includes structured personalized exercise prescription in children with obesity (study group) with a control group that will be enrolled in a multicomponent program without structured personalized exercise prescription. All children will be followed for a period of 6 months.\n\nThe parameters that will be evaluated between groups are physical fitness (measured by VO2max, ECG at rest, biomechanics and dynamometry), anthropometric measurements (weight height, BMI, plicometry, bioimpedance, metabolic (glucose oral tolerance curve, lipids, HOMA-IR, ISI-MATSUDA), early cardiovascular damage (carotid intima-media thickness, atherogenic dyslipidemia), inflammatory biomarkers (leptin, adiponectin, IL-17, IL-10, INF-gamma, IL-6, IL-12, y TNF-alpha), anxiety and depression scores evaluated with Child Depression Inventory (CID) and -Trait Anxiety Inventory for Children (STAI-CH), and allelic variants related to physical fitness (ACTN, TRH2 y FTO).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Patients with BMI ≥ Pc 95 and \\< 35kg/m2 Both sexes Accepts to participate and signs informed consent\n\nExclusion Criteria:\n\nPresence of endocrine disease including type I and II diabetes mellitus Presence of arterial hypertension Presence of primary dyslipidemia Presence of infections at moment of enrollment Presence of systemic disease Presence of genetic disorder Medical treatment that may interfere with lipid or glucose metabolism Prolonged or acute immobilization Participated in a previous similar intervention'}, 'identificationModule': {'nctId': 'NCT03552367', 'briefTitle': 'Structured Exercise Prescription Program in Obese Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital General de México Dr. Eduardo Liceaga'}, 'officialTitle': 'Efficacy of a Structured Exercise Prescription Program Over Anthropometric, Metabolic and Fitness Parameters in Obese Children and Adolescents Included in a Multicomponent Lifestyle Intervention Program. Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'DI/17/311/03/028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personalized structured exercise', 'description': 'This group will be enrolled in a multicomponent program for obese children (8-12 years old) that includes intervention workshops concerning nutrition, emotional factors, cognitive therapy and personalized structured exercise prescription that will be offered on-site and online and monitored through the use of heart rate monitoring devices. The type of exercise offered to patients in this arm is precisely designed for obese patients according to age and physical fitness parameters.\n\nIntervention: Non-personalized non-structured exercise', 'interventionNames': ['Other: Personalized structured exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-personalized non-structured exercise', 'description': 'This group will be enrolled in a multicomponent program for obese children (8-12 years old) that includes intervention workshops concerning nutrition, emotional factors, cognitive therapy and non-personalized non-structured exercise prescription Intervention: Non-personalized non-structured exercise', 'interventionNames': ['Other: Non personalized non-structured exercise program']}], 'interventions': [{'name': 'Personalized structured exercise program', 'type': 'OTHER', 'otherNames': ['Structured exercise'], 'description': 'The type of exercise offered to patients in this arm is precisely designed for obese patients according to age and physical fitness parameters. Patients are monitored using a heart rate monitor to evaluate treatment adherence and compliance', 'armGroupLabels': ['Personalized structured exercise']}, {'name': 'Non personalized non-structured exercise program', 'type': 'OTHER', 'otherNames': ['Non-structured exercise'], 'description': "The type of exercise is non-structured and patients' heart rate is not monitored. Patients receive exercise recommendations without any personalization according to their fitness parameters", 'armGroupLabels': ['Non-personalized non-structured exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06720', 'city': 'Mexico City', 'state': 'Del. Cuauhtemoc', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Nayely Garibay iIeto, MD MSc', 'role': 'CONTACT', 'email': 'gngaribay@hotmail.com', 'phone': '2789 2000'}], 'facility': 'Hospital General de Mexico Eduardo Liceaga', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Nayely Garibay Nieto, MD MSc', 'role': 'CONTACT', 'email': 'gngaribay@hotmail.com', 'phone': '+5255 2789 2000'}], 'overallOfficials': [{'name': 'Nayely Garibay Nieto, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director Child and Adolescent Obesity Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not until first article is published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General de México Dr. Eduardo Liceaga', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Council of Science and Technology, Mexico', 'class': 'OTHER'}, {'name': 'Fundacion Sertull', 'class': 'UNKNOWN'}, {'name': 'Universidad Nacional Autonoma de Mexico', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Child and Adolescent Obesity Clinic', 'investigatorFullName': 'Nayely Garibay Nieto', 'investigatorAffiliation': 'Hospital General de México Dr. Eduardo Liceaga'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-03-16', 'type': 'RELEASE'}, {'date': '2022-07-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nayely Garibay Nieto, Head of the Child and Adolescent Obesity Clinic, Hospital General de México Dr. Eduardo Liceaga'}}}}