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NCT00851201 · ClinicalTrials.gov registry record · NA
Family Weight Management Study
A NA study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- NA
- Development phase
- 360
- Enrollment target
NCT00851201 is a NA study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 360 participants.
The verdict
NCT00851201, a NA study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- NA
- Development phase
- 360 participants
- Enrollment target
Study Summary
The purpose of this study is to address the Healthy People 2010 obesity prevention objective. This study will test the effects of a comprehensive family weight management program on the BMI z-score of 7-12 year-old children with a BMI \> 85th percentile who receive primary care in a large municipal Bronx hospital. The intervention framework will draw on social marketing theory and the transtheoretical model of behavioral change to incorporate successful obesity prevention strategies. A two-arm randomized controlled clinical trial (RCT), which will enroll (n =506) 7-12 year old children with a \> 85th BMI percentile, will compare the Experimental Intensive Intervention to a Standard (Control) Intervention. The Standard Intervention will receive: 1) an initial consult, which includes an overview of lifestyle goals, 2)quarterly follow-up, 3) and a monthly newsletter. The Intensive Intervention will add: 1)12 core group modules for parents (to address roles and skills) and for children (to enhance motivation and skills and to provide physical activity), 3) Tailored support using a "toolbox" approach from community health workers as extensions of the Family Weight Management professional education staff, and 4) monthly after-core follow-up groups. The study will determine if children randomized to the Experimental Intensive Intervention will have greater improvement in BMI change (z-scores) than those randomized to the Control Standard Intervention. The study will also evaluate the effects on the Experimental Intervention on lifestyle variables and assess intervention costs. The RE-AIM evaluation will address: Reach: How many of the eligible children/ families were referred and how many of those referred actually enrolled? We will use BMI data in the computerized medical records to evaluate the proportion and the appropriateness of the referrals. Efficacy/Effectiveness: How did the Experimental intervention affect BMI (changes in z-score), and key biomarkers when followe
Interventions
- BEHAVIORAL Intensive lifestyle
- BEHAVIORAL Standard intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2009-08 |
| Est. Completion | 2013-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00851201
The ClinicalTrials.gov registry entry for NCT00851201 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intensive lifestyle is the first listed.
NCT00851201 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00851201 about?
NCT00851201 is a clinical study titled "Family Weight Management Study". The purpose of this study is to address the Healthy People 2010 obesity prevention objective. This study will test the effects of a comprehensive family weight management program on the BMI z-score of 7-12 year-old children with a BMI \> 85th percentile who receive primary care in a large municipal ...
What is the current status of trial NCT00851201?
This trial is currently completed. It is a NA study. The enrollment target is 360 participants. The study started on 2009-08. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00851201?
The interventions under investigation include: Intensive lifestyle (BEHAVIORAL), Standard intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT00851201?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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