N/A
N=697
Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01398358 ↗Enrolled (actual)
697
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Change in Body Mass Index Z-score — -0.01; 0.00; -0.04 Z-Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Parents of Preschoolers Series (Behavioral); Incredible Years Series (Behavioral)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Mass Index Z-score |
-0.01; 0.00; -0.04 | — |
| SECONDARY Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale |
0.93; 1.28; 3.92 | — |
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.
Eligibility Criteria
Inclusion Criteria
- child is enrolled in Head Start
Exclusion Criteria
- Significant developmental disabilities that would preclude participation
- Child is a foster child
- Parent is non-English speaking
Data sourced from ClinicalTrials.gov (NCT01398358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.