Site Specific Approaches to Prevention or Management of Pediatric Obesity: Child Health Initiative for Lifelong Eating and Exercise--CHILE

The purpose of this study is to design, implement, and evaluate a culturally appropriate, multi-level trans-community obesity prevention for Head Start staff, children, and their families in rural American Indian and Hispanic communities in New Mexico. The intervention, Child Health Initiative for Lifelong Eating and Exercise (CHILE) includes policy changes to address environmental determinants of healthful eating and physical activity behaviors, as well as individual and interpersonal level strategies to influence behavioral determinants. CHILE will promote increased moderate to vigorous physical activity; increased consumption of fruits, vegetables, and whole grains; decreased consumption of sweetened beverages and high-fat foods; and decreased television viewing and other screen time.

This study will employ a nested design in which 16 Head Start programs are randomly assigned to the intervention (n=8) or the control condition (n=8). Two cohorts of 3-year-old children within each Head Start center will be followed for two years post randomization. Participants will be assessed using a measurement interview protocol a total of four times: pre-intervention, twice during intervention, and two years post intervention. One of the midpoint time points will collect height and weight measurements only. This longitudinal component of the design will allow for an in-depth understanding of the processes at work in the intervention and an exploration of the hypothesized mediating effects, as well as potential moderators, such as individual characteristics of participants that may influence intervention exposure or efficacy. In order to more efficiently address these goals, the study has been divided into three phases.

Phase I will take place over the first 16 months of the study. During this time the focus will be on the identification and recruitment of Head Start centers, formative assessment with all Head Start centers, randomization of Head Start centers to the intervention or control condition, obtaining institutional review board approvals, intervention planning with intervention Head Start centers and their communities, and preparation and pilot testing of the measurement protocols.

Sixteen rural Head Start centers in predominately American Indian (6 centers) and Hispanic (10 centers) communities in NM are being recruited with the assistance of our community partners and through site visits, phone calls, and letters. In order to participate in this study, the Head Start Director will sign a memorandum of agreement (MOA), with the understanding that they may be randomized into an intervention or control condition. The MOA outlines the responsibilities of the research team and the participating sites and a list of benefits of participation. Eligibility criteria for Head Start centers will be: a) students are predominantly American Indian or Hispanic; b) a minimum of 20 3-year olds are enrolled each year; and c) the center retains at least 80% of its students for two years. Head Start children and their families will be recruited for CHILE upon their enrollment in the participating Head Start centers. For Head Start children to be eligible for the study, they must be enrolled in one of the participating Head Start centers, be 3 years old at baseline, and have an active consent form completed by their parent or legal guardian. The primary caregiver for each participating Head Start student will also participate in the study. In addition, Head Start teachers, aides, and food service workers/cooks affiliated with the 16 Head Start centers will be involved in the study, through participation in intervention training and implementation, periodic interviews and/or focus groups, and completion of written logs. In intervention Head Start communities, grocery store managers and owners, as well as the Head Start teachers, aides, and food service workers/cooks, will be involved in the intervention.

Formative assessment will take place during the first six months of the study to ensure that the intervention will meet the needs, context, and the daily realities of working in Head Start centers and communities in rural New Mexico. Similar to the principles set by the UNM PRC in other community-based participatory research efforts, and consistent with the aims of this study, the formative assessment will examine Head Start barriers and resources, and identify with Head Start staff the opportunities for integrating physical activity and nutrition into the curricula, food service, and general Head Start environment. The information gathered during this period will be used to adapt and/or design developmentally-appropriate, organizationally-feasible physical activity and nutrition interventions for the schools. Priority will be given to intervention components that have proven to be feasible in other studies. After developing and signing an MOA with each intervention and control Head Start center that outlines research study aims and roles and responsibilities, study staff will use a modified version of the Environmental Checklist developed for Pathways to identify potential environmental foci for change.