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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 is a Phase 3 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 167 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01546727
The ClinicalTrials.gov registry entry for NCT01546727 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 167 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Motivational Interviewing is the first listed.
NCT01546727 reports 0 study locations.
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.
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