Team PLAY (Positive Lifestyles for Active Youngsters)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00528164
First received: September 11, 2007
Last updated: February 15, 2013
Last verified: February 2013

September 11, 2007
February 15, 2013
September 2006
June 2012   (final data collection date for primary outcome measure)
Primary - Body Mass index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Primary - Body Mass index [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00528164 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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. [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Team PLAY (Positive Lifestyles for Active Youngsters)
Treating Childhood Obesity With Family Lifestyle Change

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obesity
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.
  • Experimental: Team PLAY Group
    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.
    Intervention: Behavioral: Team PLAY
  • No Intervention: Standard Care Group
    Participants receive standard care by primary care physician.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
4 Years to 7 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00528164
1RO1HDO50895-01, USPHS Gr HD-050895-01
Yes
University of Tennessee
University of Tennessee
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Marion E Hare, MD,MS University of Tennessee
University of Tennessee
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP