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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: Completed Early Phase 1 study, sponsored by University of Florida.

NCT00248677 is a Early Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 93 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 93 participants
Start Date 2005-09
Est. Completion 2008-08
Phase Early Phase 1
University of Florida

1,106 total trials

What the finished NCT00248677 record still lists

NCT00248677 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% higher).

The record links to 0 conditions, and to 2 interventions - of which Behavioral Family-Based Intervention is the first listed.

NCT00248677 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00248677's enrollment target sits among peer trials

93 229th of 2000 higher than 1,772 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00248677, the US trial registry maintained by the National Library of Medicine. NCT00248677 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.