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Sponsors and Collaborators: |
University of Tennessee Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | University of Tennessee |
ClinicalTrials.gov Identifier: | NCT00528164 |
The purpose of this study is to determine whether an intense family-centered program to help children, 4 to 7 years old, control their weight is more effective than the advise and referrals their health provider gives in the primary care office.
Condition | Intervention | Phase |
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Obesity |
Behavioral: Team PLAY |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Treating Childhood Obesity With Family Lifestyle Change |
Estimated Enrollment: | 240 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | March 2012 |
Arms | Assigned Interventions |
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1: Experimental
6-month family-centered intervention to increase physical activity and healthy eating patterns, primarily directed at parents.
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Behavioral: Team PLAY
Parents will receive intense counseling regarding developmentally appropriate physical activity, strategies for reducing sedentary behaviors, nutritional counseling, and behavioral counseling, including a self-management program to use with their children at home. The group will meet once a week for the initial 8 weeks, bi-weekly for 8 weeks, and monthly for 2 months.
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2: No Intervention
Participants receive standard care by primary care physician.
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This randomized controlled trial is designed to determine whether an intense 6 month family-centered intervention to increase physical activity and health eating patterns, primarily directed at parents, followed by a 6 month maintenance period, will be significantly more successful in controlling weight in overweight/obese children, ages 4-7 years, than usual standard care, at 2 years after enrollment. The intervention group (120 children with a BMI > 85% percentile) will receive standard of care, as well as, additional parental counseling. Parents will receive intense counseling regarding developmentally appropriate physical activity, strategies for reducing sedentary behaviors, nutritional counseling, and behavioral counseling including a self-management program to use with their children at home. The group will meet once a week for the initial 8 weeks, biweekly for 8 weeks, and monthly for 2 months. Following this period (the next 6 months), a case manager will call the family on a monthly basis and the family will be sent educational and support information by mail. The control group (120 children with a BMI > 85% percentile) will receive standard care provided by their primary care provider and be offered a six week optional parenting class. All children will have a medical history, physical examination, and anthropometric measures, nutritional assessment, measurement of physical activity, and behavioral/psycho-social measures provided by study personnel. Outcome measurements will be done at baseline, 6, 12, 18, and 24 months.
Ages Eligible for Study: | 4 Years to 7 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marion E Hare, MD, MS | 901-448-3752 | mhare@utmem.edu |
Contact: Sarah Hencyk, MS,RD, LDN | 901-448-6876 | shencyk@utmem.edu |
United States, Tennessee | |
University of Tennessee, Department of Preventive Medicine | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Principal Investigator: Marion E Hare, MD, MS |
Principal Investigator: | Marion E Hare, MD,MS | University of Tennessee |
Responsible Party: | University of Tennessee ( Marion E. hare, MD/MS ) |
Study ID Numbers: | 1RO1HDO50895-01, USPHS Gr HD-050895-01 |
Study First Received: | September 11, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00528164 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
children overweight obesity family intervention control |
randomized physical activity diet nutrition behavior body mass index |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |