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NCT01398358 · ClinicalTrials.gov registry record · NA
Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 697
- Enrollment target
NCT01398358: Completed NA study, sponsored by University of Michigan.
NCT01398358 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 697 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01398358, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 697 participants
- Enrollment target
Study Summary
The goal of this integrated project targeting the Childhood Obesity Prevention Challenge Area is to reduce the prevalence of obesity among children attending Head Start in Michigan. The proposed intervention program is based on Social Cognitive theory and the premise that enhancing children's capacity for emotional and behavioral self-regulation is a key component of effective obesity prevention. A randomized controlled trial design is proposed to evaluate, among 600 Head Start children and their parents, the effectiveness of 2 approaches to obesity prevention: (1) the Parents of Preschoolers Prevention Series (POPS), a curriculum delivered to preschoolers and their parents focused on obesity-related health behaviors; and (2) POPS in combination with the Incredible Years Series (IYS), an evidence-based program designed to improve preschoolers' emotional and behavioral self-regulation. The research objective is to test the hypotheses that: (1) POPS, compared to Usual Head Start exposure, will lead to greater improvements in obesity-related health behaviors and adiposity indices; and (2) POPS + IYS will lead to the greatest improvements in obesity-related health behaviors and adiposity indices, and this effect will be mediated by improved self-regulation. The extension objective is to evaluate the feasibility, fidelity, and educational effectiveness of the POPS and POPS + IYS interventions, as delivered by paraprofessionals and educators within Extension and Head Start. The education objective is to provide Extension and Head Start staff non-formal training and educational curricula which can be widely disseminated. The long-term goal of this project is disseminate a novel and effective approach to obesity prevention in preschoolers.
Primary Outcome
Child BMI z-score was calculated from measure height and weight at enrollment and at the end of the study period
Interventions
- BEHAVIORAL Parents of Preschoolers Series
- BEHAVIORAL Incredible Years Series
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 697 participants |
| Start Date | 2011-03 |
| Est. Completion | 2015-05 |
| Phase | NA |
What the finished NCT01398358 record still lists
NCT01398358 is an interventional study that assigns participants to a tested intervention. The registered 697 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Parents of Preschoolers Series is the first listed.
NCT01398358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01398358 about?
NCT01398358 is a clinical study titled "Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers". The goal of this integrated project targeting the Childhood Obesity Prevention Challenge Area is to reduce the prevalence of obesity among children attending Head Start in Michigan. The proposed intervention program is based on Social Cognitive theory and the premise that enhancing children's capaci...
What is the current status of trial NCT01398358?
This trial is currently completed. It is a NA study. The enrollment target is 697 participants. The study started on 2011-03. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01398358?
The interventions under investigation include: Parents of Preschoolers Series (BEHAVIORAL), Incredible Years Series (BEHAVIORAL).
Who is sponsoring clinical trial NCT01398358?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01398358's enrollment target sits among peer trials
697 151st of 2000 higher than 1,850 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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