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NCT01546727 · ClinicalTrials.gov registry record · Phase 3
Behavioral Treatment for Obese Preschoolers
A Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 3
- Development phase
- 167
- Enrollment target
NCT01546727: Completed Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01546727 is a Phase 3 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 167 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01546727, a Phase 3 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 167 participants
- Enrollment target
Study Summary
This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic and home family behavioral intervention (LAUNCH) against 1) motivational interviewing (attention control; MI) and 2) standard of care (true standard of care control; STC) with 168 children ages 2 to 5 years who meet the criteria for obesity (\>95th percentile for body mass index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH, MI) or standard of care. The primary end-point will be change in BMI z-score at the end of treatment. The investigators will also assess maintenance of treatment gains at 6 and 12 months after treatment, and changes in factors thought to be mechanisms for change in weight (food intake and activity level), changes in the obesiogenic environment (parent weight, food intake and activity, and changes in the home food environment) and factors that could be negatively impacted (parent and child eating and feeding interactions).
Primary Outcome
Body Mass Index z-score
Interventions
- BEHAVIORAL Motivational Interviewing
- BEHAVIORAL Behavioral Family Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
What the finished NCT01546727 record still lists
NCT01546727 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Motivational Interviewing is the first listed.
NCT01546727 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01546727 about?
NCT01546727 is a clinical study titled "Behavioral Treatment for Obese Preschoolers". This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic and home family behavioral intervention (LAUNCH) against 1) motivational interviewing (attention control; MI) and 2) standard of care (true standard of care control; STC) with 168 children ages 2 to 5 years ...
What is the current status of trial NCT01546727?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 167 participants. The study started on 2012-03. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01546727?
The interventions under investigation include: Motivational Interviewing (BEHAVIORAL), Behavioral Family Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01546727?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01546727's enrollment target sits among peer trials
167 1463rd of 2000 higher than 538 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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