Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| USPHS Gr HD-050895-01 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard Care Group | No Intervention | Participants receive standard care by primary care physician. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary - Body Mass index | 2 years |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marion E Hare, MD,MS | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee, Department of Preventive Medicine | Memphis | Tennessee | 38105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22882115 | Background | 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. | |
| 22342450 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D009043 | Motor Activity |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| 21057255 | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |