Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285558
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2006-01-31
Brief Title:
Peer-enhanced Intervention to Support Teen Weight Loss
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Peer-Enhanced Intervention to Support Teen Weight Loss
Status:
COMPLETED
Status Verified Date:
2017-10
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:
None
Brief Summary:
The purpose of this study is to determine whether adding a peer-based intervention based on an outward bound model is more effective than a standard behavioral weight intervention for helping adolescents lose weight
Detailed Description:
The prevalence of overweight in children and adolescents has increased significantly during the last two decades While there are empirically supported weight management interventions for school age children treatment findings with overweight adolescents are not as consistent A potential limitation of weight control interventions for adolescents is the minimal attention given to the peer group as an active component of treatment We have promising findings from a pilot study that involves adding an innovative peer-based intervention peer-based skills training PBST to cognitive- behavioral weight management treatment for adolescents The purpose of the proposed study is to expand the pilot by 1 increasing our sample size 2 assessing weight loss over a longer time period and 3 evaluating the role of psychosocial variables as well as physical activity and diet in mediating treatment outcome It is hypothesized that overweight adolescents randomized to cognitive-behavioral treatment with peer enhancement will demonstrate greater weight loss at long term follow-up than adolescents randomized to cognitive-behavioral treatment with exercise
One hundred and fifty adolescents between the ages of 13 and 16 years and 20 and 90 overweight will be randomized to one of two treatment conditions 1 Cognitive-Behavioral Weight Loss Treatment with Peer-Based Skills Training CBTPBST or 2 Cognitive-Behavioral Weight Loss Treatment with Exercise CBTEXER Measures of height weight physical activity diet and psychosocial functioning will be obtained at baseline end of treatment 12 months and 24 months after randomization A between-groups t-test will be conducted to evaluate group differences in change in percent overweight between baseline and 24-month follow-up Hierarchical linear modeling will be used to assess the pattern of weight loss for the two treatment groups across four time points baseline end of treatment 12 month and 24 month follow-up Effects of treatment on psychosocial measures will be analyzed using mixed analysis of variance with treatment condition as the between subjects factor and a within subject factor of time Finally a series of regression analyses will be conducted to evaluate the role of psychosocial variables physical activity and diet as mediators of treatment outcome
One hundred and fifty adolescents between the ages of 13 and 16 years and 20 and 90 overweight will be randomized to one of two treatment conditions 1 Cognitive-Behavioral Weight Loss Treatment with Peer-Based Skills Training CBTPBST or 2 Cognitive-Behavioral Weight Loss Treatment with Exercise CBTEXER Measures of height weight physical activity diet and psychosocial functioning will be obtained at baseline end of treatment 12 months and 24 months after randomization A between-groups t-test will be conducted to evaluate group differences in change in percent overweight between baseline and 24-month follow-up Hierarchical linear modeling will be used to assess the pattern of weight loss for the two treatment groups across four time points baseline end of treatment 12 month and 24 month follow-up Effects of treatment on psychosocial measures will be analyzed using mixed analysis of variance with treatment condition as the between subjects factor and a within subject factor of time Finally a series of regression analyses will be conducted to evaluate the role of psychosocial variables physical activity and diet as mediators of treatment outcome
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 |
|---|---|---|---|
| R01DK062916 | NIH | None | httpsreporternihgovquickSearchR01DK062916 |