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Team PLAY (Positive Lifestyles for Active Youngsters)
This study is currently recruiting participants.
Verified by University of Tennessee, October 2008
Sponsors and Collaborators: University of Tennessee
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: University of Tennessee
ClinicalTrials.gov Identifier: NCT00528164
  Purpose

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
Obesity
Behavioral: Team PLAY
Phase II
Phase III

MedlinePlus related topics: Obesity Obesity in Children
U.S. FDA Resources
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

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Primary - Body Mass index [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: September 2006
Estimated Study Completion Date: March 2012
Arms Assigned Interventions
1: Experimental
6-month family-centered intervention to increase physical activity and healthy eating patterns, primarily directed at parents.
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.
2: No Intervention
Participants receive standard care by primary care physician.

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 (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.

  Eligibility

Ages Eligible for Study:   4 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528164

Contacts
Contact: Marion E Hare, MD, MS 901-448-3752 mhare@utmem.edu
Contact: Sarah Hencyk, MS,RD, LDN 901-448-6876 shencyk@utmem.edu

Locations
United States, Tennessee
University of Tennessee, Department of Preventive Medicine Recruiting
Memphis, Tennessee, United States, 38105
Principal Investigator: Marion E Hare, MD, MS            
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Marion E Hare, MD,MS University of Tennessee
  More Information

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

Keywords provided by University of Tennessee:
children
overweight
obesity
family
intervention
control
randomized
physical activity
diet
nutrition
behavior
body mass index

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on January 15, 2009