Clinical Trials Directory

Trials / Completed

CompletedNCT00528164

Team PLAY (Positive Lifestyles for Active Youngsters)

Treating Childhood Obesity With Family Lifestyle Change

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
270 (actual)
Sponsor
University of Tennessee · Academic / Other
Sex
All
Age
4 Years – 7 Years
Healthy volunteers
Accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTeam PLAYParents 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.

Timeline

Start date
2006-09-01
Primary completion
2012-06-01
Completion
2012-06-01
First posted
2007-09-12
Last updated
2013-02-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00528164. Inclusion in this directory is not an endorsement.