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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Michigan State University
Information provided by (Responsible Party):
Julie Lumeng, University of Michigan
ClinicalTrials.gov Identifier:
NCT01398358
First received: July 19, 2011
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Parents of Preschoolers Series
Behavioral: Incredible Years Series

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Body mass index [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dietary quality assessed by three 24-hour dietary recalls [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Child's Amount of Television Viewing [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Ability to Delay Gratification [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Emotional Eating [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Food-related tantrums [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Head Start Exposure
Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
Experimental: Parents of Preschoolers Series (POPS)
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.
Behavioral: Parents of Preschoolers Series

The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.

The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal setting. "Family Links" and "Parent Pages" are sent home to reinforce content from school to home.

Experimental: POPS + Incredible Years Series (IYS)
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.
Behavioral: Parents of Preschoolers Series

The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.

The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal setting. "Family Links" and "Parent Pages" are sent home to reinforce content from school to home.

Behavioral: Incredible Years Series

The Parent component (BASIC) is a group-based program (12-14 weeks, 2 hours/week) focused on enhancing parenting skills such as using effective praise, incentives, and limit-setting, and handling misbehavior. Parents complete homework activities that will be reviewed in group sessions and receive follow-up reinforcement phone calls.

For the Child component ("Dinosaur School"), 60, 15-20 minute lessons are delivered during "Circle Time" in Head Start classrooms followed by small group activities. The curriculum focuses on teaching self-regulation skills, problem-solving strategies, and prosocial behaviors.

Teachers are trained in classroom management strategies.


  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398358

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-5406
Sponsors and Collaborators
University of Michigan
Michigan State University
  More Information

Publications:
Responsible Party: Julie Lumeng, Associate Professor of Pediatrics, University of Michigan
ClinicalTrials.gov Identifier: NCT01398358     History of Changes
Other Study ID Numbers: 2010-04785
Study First Received: July 19, 2011
Last Updated: September 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
obesity
prevention
children

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014