Team PLAY (Positive Lifestyles for Active Youngsters)

NCT00528164 | Completed Phase 2 DMC

• 2 other identifiers: 1RO1HDO50895-01USPHS Gr HD-050895-01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

children; overweight; obesity; family; intervention; control; randomized; physical activity; diet; nutrition; behavior; body mass index

Outcome Measures

Primary Outcomes (1)

• Primary - Body Mass index

  2 years

Secondary Outcomes (1)

• 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

Study Arms (2)

Team PLAY Group

EXPERIMENTAL

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

Standard Care Group

NO INTERVENTION

Participants receive standard care by primary care physician.

Interventions

Team PLAY BEHAVIORAL

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.

Team PLAY Group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Tennessee: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Tennessee, Department of Preventive Medicine

Memphis, Tennessee, 38105, United States

Location

Related Publications (3)

• Williams NA, Fournier J, Coday M, Richey PA, Tylavsky FA, Hare ME. Body esteem, peer difficulties and perceptions of physical health in overweight and obese urban children aged 5 to 7 years. Child Care Health Dev. 2013 Nov;39(6):825-34. doi: 10.1111/j.1365-2214.2012.01401.x. Epub 2012 Aug 8.

  PMID: 22882115 BACKGROUND

• Hare ME, Coday M, Williams NA, Richey PA, Tylavsky FA, Bush AJ. Methods and baseline characteristics of a randomized trial treating early childhood obesity: the Positive Lifestyles for Active Youngsters (Team PLAY) trial. Contemp Clin Trials. 2012 May;33(3):534-49. doi: 10.1016/j.cct.2012.02.003. Epub 2012 Feb 10.

  PMID: 22342450 BACKGROUND

• Williams NA, Coday M, Somes G, Tylavsky FA, Richey PA, Hare M. Risk factors for poor attendance in a family-based pediatric obesity intervention program for young children. J Dev Behav Pediatr. 2010 Nov-Dec;31(9):705-12. doi: 10.1097/DBP.0b013e3181f17b1c.

  PMID: 21057255 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity; Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marion E Hare, MD,MS

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 12, 2007
• Study Start: September 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 18, 2013

Record last verified: 2013-02

Locations

US (1)