Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT00107692
Status:
UNKNOWN
Last Update Posted:
2006-09-13
First Post:
2005-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can a Physical Activity Skill Development and Parent-Centered Dietary Intervention Help Combat Child Obesity?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D063766', 'term': 'Pediatric 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': 'D015444', 'term': 'Exercise'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 216}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2007-10'}, 'lastUpdateSubmitDate': '2006-09-11', 'studyFirstSubmitDate': '2005-04-06', 'studyFirstSubmitQcDate': '2005-04-06', 'lastUpdatePostDateStruct': {'date': '2006-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-04-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program'}, {'measure': 'a physical activity skill development program'}, {'measure': 'and a parent-centered dietary modification + physical activity skill development program.'}]}, 'conditionsModule': {'keywords': ['Child Obesity', 'Physical activity', 'community intervention study', 'competence', 'diet and nutrition', 'Nutrition'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '21670711', 'type': 'DERIVED', 'citation': 'Burrows T, Janet WM, Collins CE. Long-term changes in food consumption trends in overweight children in the HIKCUPS intervention. J Pediatr Gastroenterol Nutr. 2011 Nov;53(5):543-7. doi: 10.1097/MPG.0b013e3182274829.'}, {'pmid': '21444600', 'type': 'DERIVED', 'citation': 'Collins CE, Okely AD, Morgan PJ, Jones RA, Burrows TL, Cliff DP, Colyvas K, Warren JM, Steele JR, Baur LA. Parent diet modification, child activity, or both in obese children: an RCT. Pediatrics. 2011 Apr;127(4):619-27. doi: 10.1542/peds.2010-1518. Epub 2011 Mar 28.'}, {'pmid': '21226540', 'type': 'DERIVED', 'citation': 'Burrows T, Collins CE, Garg ML. Omega-3 index, obesity and insulin resistance in children. Int J Pediatr Obes. 2011 Jun;6(2-2):e532-9. doi: 10.3109/17477166.2010.549489. Epub 2011 Jan 12.'}, {'pmid': '20473216', 'type': 'DERIVED', 'citation': 'Cliff DP, Okely AD, Morgan PJ, Steele JR, Jones RA, Colyvas K, Baur LA. Movement skills and physical activity in obese children: randomized controlled trial. Med Sci Sports Exerc. 2011 Jan;43(1):90-100. doi: 10.1249/MSS.0b013e3181e741e8.'}, {'pmid': '20447648', 'type': 'DERIVED', 'citation': 'Okely AD, Collins CE, Morgan PJ, Jones RA, Warren JM, Cliff DP, Burrows TL, Colyvas K, Steele JR, Baur LA. Multi-site randomized controlled trial of a child-centered physical activity program, a parent-centered dietary-modification program, or both in overweight children: the HIKCUPS study. J Pediatr. 2010 Sep;157(3):388-94, 394.e1. doi: 10.1016/j.jpeds.2010.03.028. Epub 2010 May 6.'}, {'pmid': '19437180', 'type': 'DERIVED', 'citation': 'Burrows T, Warren JM, Collins CE. The impact of a child obesity treatment intervention on parent child-feeding practices. Int J Pediatr Obes. 2010;5(1):43-50. doi: 10.3109/17477160902957158.'}, {'pmid': '19158237', 'type': 'DERIVED', 'citation': 'Jones RA, Warren JM, Okely AD, Collins CE, Morgan PJ, Cliff DP, Burrows T, Cleary J, Baur LA. Process evaluation of the Hunter Illawarra Kids Challenge Using Parent Support study: a multisite randomized controlled trial for the management of child obesity. Health Promot Pract. 2010 Nov;11(6):917-27. doi: 10.1177/1524839908328994. Epub 2009 Jan 21.'}, {'pmid': '18997681', 'type': 'DERIVED', 'citation': "Burrows TL, Warren JM, Colyvas K, Garg ML, Collins CE. Validation of overweight children's fruit and vegetable intake using plasma carotenoids. Obesity (Silver Spring). 2009 Jan;17(1):162-8. doi: 10.1038/oby.2008.495. Epub 2008 Nov 6."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study, and its original contribution to research, is to determine the impact of a physical activity skill development and parent centered family weight management program on the weight, cardiovascular health, physical activity, dietary intake and sedentary behaviors of overweight and obese children.', 'detailedDescription': 'AIMS\n\nThe aim of this randomized controlled trial (RCT) is to evaluate and compare in overweight children the effectiveness of the following interventions:\n\n1\\. a parent-centered dietary modification program; 2. a physical activity skill development program; and 3. a parent-centered dietary modification + physical activity skill development program.\n\nBACKGROUND\n\nWe have successfully piloted two community-based conventional weight management programs, SHARK (a physical activity-based program) and PRAISE (a dietary modification program), suitable for use with overweight, pre-adolescent children, and propose that the combination of these two programs into a multi-component intervention has the potential to effectively treat child obesity. We hypothesize that at 6-, 12-, and 24-month follow-ups, compared to overweight children allocated to the physical activity only and dietary modification only groups, overweight children in the physical activity + dietary modification group will display a greater reduction in their adiposity and display improved metabolic profiles. Secondary analyses will determine if the combined intervention improves physical activity, sedentariness, energy intake, movement skills, self-esteem, and an activity of daily living.\n\nRESEARCH PLAN\n\nStudy design: An assessor-blinded randomized controlled trial.\n\nParticipants and their recruitment: 216 overweight children in Wollongong and Newcastle aged 6-9 years will be recruited. Each site will recruit 108 participants, 36 in each treatment arm. Recruitment will occur through the Media Units at both universities, through local GPs (general practitioners) and pediatricians.\n\nInclusion criteria: BMI (Body Mass Index) above international cut-off points for age and gender, one parent able to attend all required sessions, pre-pubertal, and no sibling enrolled.\n\nExclusion criteria: Extreme obesity (BMI SD \\[mean\\] score \\> 3.5), known syndromal causes of obesity, long term oral steroids, medications associated with weight gain, chronic illness, dietary restriction.\n\nAllocation to groups: Computer-based random number-producing algorithm schedule.\n\nInterventions: SHARK Physical activity skill development program. The "SHARK" program focuses on increasing the children\'s actual competence (or fundamental movement skills), perceived competence, and social support for physical activity. PRAISE parent-centered family weight management program. The PRAISE Program is a non-diet approach to healthy eating that aims to decrease overly restrictive eating and encourage eating in response to "true hunger".\n\nAssessment of outcome variables: assessed at baseline, 6-, 12-, and 24-month follow-ups.\n\nAdiposity: BMI SD score, height, weight, and waist circumference. Metabolic profile measures: blood pressure; cholesterol, triglycerides; glucose and insulin.\n\nPhysical activity energy expenditure and sedentary activities: total kilocalories expended and time spent in sedentary activities.\n\nDietary energy intake: 4-day weighed food record (2 week days and the week-end), parent selection of lower fat items in the household grocery shopping and behavior changes related to a healthy lifestyle.\n\nActual and perceived competence: Test of Gross Motor Development and the Self-Perception Profile for Children.\n\nActivity of daily living: Sit-to-stand transfer.\n\nStatistical analyses: intention-to-treat analysis using the 12-month follow-up as the initial endpoint and 24-month follow-up as final data point.\n\nQuality-assurance. Site bias, standardized and clearly defined protocols and retention strategies have been fully addressed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '66 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight and obese children with the Wollongong and Newcastle regions, aged between 5.5 and 9\n* BMI within specified range\n* Otherwise healthy children\n* Not on any medications that may influence obesity\n* One parent able to attend all required sessions\n* Pre-pubertal\n* No sibling enrolled\n\nExclusion Criteria:\n\n* Children with BMI outside the specified range\n* Children on medication that may influence obesity\n* Children that have conditions that may influence obesity'}, 'identificationModule': {'nctId': 'NCT00107692', 'briefTitle': 'Can a Physical Activity Skill Development and Parent-Centered Dietary Intervention Help Combat Child Obesity?', 'organization': {'class': 'OTHER', 'fullName': 'University of Wollongong'}, 'officialTitle': 'Effect of a Weight Management Program for Overweight and Obese Children: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NHMRC Project Grant 354101'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Physical activity and diet', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2308', 'city': 'Newcastle', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'University of Newcastle', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}, {'zip': '2522', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Child Obesity Research Centre, University of Wollongong', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}], 'overallOfficials': [{'name': 'Tony D Okely, PhD, BEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wollongong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wollongong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Newcastle University', 'class': 'OTHER'}, {'name': 'University of Sydney', 'class': 'OTHER'}, {'name': 'Illawarra Area Health Services', 'class': 'OTHER'}]}}}