Clinical trial NCT01398358: Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers
Official title: Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
prevention
children
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan State University
First posted: 2011-07-20
Enrollment: 697
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Body Mass Index Z-score
timeFrame: 9 months
Secondary outcomes:
measure: Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale
timeFrame: 9 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Julie Lumeng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller AL, Horodynski MA, Herb HE, Peterson KE, Contreras D, Kaciroti N, Staples-Watson J, Lumeng JC. Enhancing self-regulation as a strategy for obesity prevention in Head Start preschoolers: the growing healthy study. BMC Public Health. 2012 Nov 30;12:1040. doi: 10.1186/1471-2458-12-1040.
citation: Jansen EC, Miller AL, Lumeng JC, Kaciroti N, Brophy Herb HE, Horodynski MA, Contreras D, Peterson KE. Externalizing behavior is prospectively associated with intake of added sugar and sodium among low socioeconomic status preschoolers in a sex-specific manner. Int J Behav Nutr Phys Act. 2017 Oct 3;14(1):135. doi: 10.1186/s12966-017-0591-y.