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Clinical Trials/NCT01398358
NCT01398358
Completed
N/A

Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers

University of Michigan1 site in 1 country697 target enrollmentMarch 2011
ConditionsObesity

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Michigan
Enrollment
697
Locations
1
Primary Endpoint
Change in Body Mass Index Z-score
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
May 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julie Lumeng

Associate Professor of Pediatrics

University of Michigan

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

Outcomes

Primary Outcomes

Change in Body Mass Index Z-score

Time Frame: 9 months

Child BMI z-score was calculated from measure height and weight at enrollment and at the end of the study period

Secondary Outcomes

  • Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale(9 months)

Study Sites (1)

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