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NCT00248677 · ClinicalTrials.gov registry record · Early Phase 1
Sensible Treatment of Obesity in Rural Youth . . .
A Early Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 93
- Enrollment target
NCT00248677 is a Early Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 93 participants.
The verdict
NCT00248677, a Early Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 93 participants
- Enrollment target
Study Summary
Project STORY (Sensible Treatment of Obesity in Rural Youth) will entail a three-arm randomized controlled trial to test the effectiveness of interventions designed to promote successful weight management in an important population, overweight children and their parents in medically underserved, rural settings. The current feasibility study will provide pilot data to develop and support a full-scale trial that will be implemented across multiple rural counties. In this pilot program, participants will be randomly assigned to one of two, 4-month long intervention programs that will be delivered in rural communities through Cooperative Extension Offices, or to a Wait List Control (WLC) group. The Behavioral Family-Based Intervention (BFI) will involve simultaneous, but separate treatment groups for both the child and their parent(s). The Behavioral Parent-Based Intervention (BPI) will involve groups for only the parent(s). Both programs will take a behavioral lifestyle approach to gradually modify dietary and physical activity patterns. The aims of the trial and its principal hypotheses are listed below. AIMS: * Evaluate the effects on child's standardized body mass index (BMI-z) of BPI and BFI delivered via group contacts to overweight children and/or their overweight parents in rural counties. * Examine changes in children's dietary intake, physical activity, self-esteem, and body image. * Compare the cost-effectiveness of the BPI and BFI. * Evaluate the effects of the BPI and BFI on parent BMI.
Interventions
- BEHAVIORAL Behavioral Family-Based Intervention
- BEHAVIORAL Behavioral Parent-Based Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-08 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00248677
The ClinicalTrials.gov registry entry for NCT00248677 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Behavioral Family-Based Intervention is the first listed.
NCT00248677 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00248677 about?
NCT00248677 is a clinical study titled "Sensible Treatment of Obesity in Rural Youth . . .". Project STORY (Sensible Treatment of Obesity in Rural Youth) will entail a three-arm randomized controlled trial to test the effectiveness of interventions designed to promote successful weight management in an important population, overweight children and their parents in medically underserved, rur...
What is the current status of trial NCT00248677?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 93 participants. The study started on 2005-09. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00248677?
The interventions under investigation include: Behavioral Family-Based Intervention (BEHAVIORAL), Behavioral Parent-Based Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT00248677?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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