Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00241891
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-10-17
Brief Title:
Behavior Change Family Counseling to Reduce Rate of Weight Gain in At-Risk Children
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Primary Care Obesity Prevention One or Multiple Targets
Status:
COMPLETED
Status Verified Date:
2015-04
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:
This study will train primary care providers to counsel families on behavior change that is aimed at reducing the rate of weight gain in at-risk children
Detailed Description:
BACKGROUND
In addition to family school and community primary care is a promising setting for childhood obesity prevention However most pediatric primary care providers are not trained to deliver behavior modification interventions and according to preliminary data are less likely to address obesity prevention when they perceive insufficient time during well-care visits
DESIGN NARRATIVE
This is a controlled study of obesity prevention with group randomization of two standardized 12-month intervention strategies at the practice level The intervention strategies are based on the behavioral economics theory and will be delivered by primary care providers after training in behavior modification The first strategy will target change in multiple behaviors while the second strategy will target only one behavior beverage consumption These two interventions will be compared to an active control intervention that is unrelated to weight bullying prevention Six to seven primary care practices will be randomized to each arm with 21 patients per practice for a total of 17 practices and 350 patients The primary aim is to demonstrate that either obesity prevention intervention will result in less body mass index BMI increase adjusted using z-score in children age 8 to 12 years who are at risk for overweight BMI 50th-95th percentile as compared to a control intervention The study also hypothesizes that the multiple-behavior intervention the single-behavior intervention or both will result in less adjusted BMI increase than the control intervention at 24 months post-randomization with no a priori assumption in differences between the two obesity prevention strategies Blood pressure insulin resistance dyslipidemia and oral health status will be secondary outcomes Intermediate behavioral outcomes and process data will be collected
In addition to family school and community primary care is a promising setting for childhood obesity prevention However most pediatric primary care providers are not trained to deliver behavior modification interventions and according to preliminary data are less likely to address obesity prevention when they perceive insufficient time during well-care visits
DESIGN NARRATIVE
This is a controlled study of obesity prevention with group randomization of two standardized 12-month intervention strategies at the practice level The intervention strategies are based on the behavioral economics theory and will be delivered by primary care providers after training in behavior modification The first strategy will target change in multiple behaviors while the second strategy will target only one behavior beverage consumption These two interventions will be compared to an active control intervention that is unrelated to weight bullying prevention Six to seven primary care practices will be randomized to each arm with 21 patients per practice for a total of 17 practices and 350 patients The primary aim is to demonstrate that either obesity prevention intervention will result in less body mass index BMI increase adjusted using z-score in children age 8 to 12 years who are at risk for overweight BMI 50th-95th percentile as compared to a control intervention The study also hypothesizes that the multiple-behavior intervention the single-behavior intervention or both will result in less adjusted BMI increase than the control intervention at 24 months post-randomization with no a priori assumption in differences between the two obesity prevention strategies Blood pressure insulin resistance dyslipidemia and oral health status will be secondary outcomes Intermediate behavioral outcomes and process data will be collected
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 |
|---|---|---|---|
| R01HL084056 | NIH | None | httpsreporternihgovquickSearchR01HL084056 |