Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00528164
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2007-09-11
Brief Title:
Team PLAY Positive Lifestyles for Active Youngsters
Sponsor:
University of Tennessee
Organization:
University of Tennessee
Study Overview
Official Title:
Treating Childhood Obesity With Family Lifestyle Change
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Team PLAY
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
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 overweightobese 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 behavioralpsycho-social measures provided by study personnel Outcome measurements will be done at baseline 6 12 18 and 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| USPHS Gr HD-050895-01 | None | None | None |