Team PLAY (Positive Lifestyles for Active Youngsters)

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (180 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 (60 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.

Official Title
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Treating Childhood Obesity With Family Lifestyle Change

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Team PLAY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 4 to 7 years of age, male or female, of any race who have a BMI > 85% for age. All participants and parents must be able to speak and understand English. Exclusion Criteria: History of diabetes mellitus History of significant renal, hepatic, cardiovascular,or gastrointestinal disease Receiving drugs known to alter glucose homeostasis Physical disabilities that limit physical activity (i.e. orthopedic, congenital) Diagnosis of hypertension by a medical provider that requires limited physical activity Psychological disabilities that might limit participation; Lack of access to a telephone Lack of access to transportation for the intervention Current participation in another clinical trial (current participation in an observational study is not an exclusion.) Other medical or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol. Unable to speak and understand English

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Team PLAY Group<br>6-month family-centered intervention to increase physical activity and healthy eating patterns, primarily directed at parents. 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. | Behavioral: Team PLAY<br>* 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.<br>|
| No Intervention: Standard Care Group<br>Participants receive standard care by primary care physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary - Body Mass index |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition (DXA), physical activity (accelerometry), dietary changes (Block Food Frequency), Flexibility and Cohesion Evaluation Scales, MacArthur Behavior and Health Questionnaire and Body Esteem Scale. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, children, overweight, family, intervention, control, randomized, physical activity, diet, nutrition, behavior, body mass index