Please select the eligibility criteria that correspond to the clinical trial below.
Title: Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers
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.


Options:
A: Primary Outcome Measures

Inclusion:

* Enrolled in a participating Head Start program
* Age 33 months to 5 years (i.e., meets Head Start age eligibility criteria)

Exclusion:

* Those not meeting inclusion criteria

Secondary Outcome Measures

Inclusion:

* Enrolled in a participating Head Start program
* Age 33 months to 5 years

Exclusion:

* Children not enrolled at a participating Head Start program
* Children less than 29 months or older than 59 months by Sept 1
B: Inclusion Criteria:

* Have received an annual physical
* Parent or guardian willing to give informed consent
* Parent or guardian willing to provide demographic and anthropometric data and agree to complete food intake and physical activity information for their child

Exclusion Criteria:

* Requires a specialized diet outside of that served by the Chicago Public Schools
* Has a chronic physical or behavioral disorder that requires participant to be under close medical psychological supervision and routinely absent from the study
C: 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
D: Inclusion Criteria. Centers must have met the following criteria to be included: (1) have \> 30 children ages 2-5 enrolled; (2) Serve low income families who are a part of the USDA food program and SNAP eligible; (3) Reflect the ethnic distribution of the Miami-Dade County Public School System (63 percent Hispanic, 19 percent African American, 18 percent white); and (4) Center directors agree to participate and sign a letter of commitment. Studies were excluded if they did not meet these criteria.

Answer: C