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.

Observations of Head Start students during recess, before school, at lunch, and at other
"open" times will be conducted by members of the research team at Head Start centers to gain
information about their level and intensity of physical activity during the school day, as
well as to identify locations used for physical activity.

Finally, during the formative assessment phase, height and weight data will be collected for
current Head Start students (not study participants), so that Head Start centers can be
grouped by median BMI percentile values for randomization.

Following the formative assessment, Head Start centers will be randomly assigned to the
intervention or control condition. To ensure that the baseline average BMI percentile will
be similar in control and intervention groups, Head Start centers will be assigned by a
stratified randomization process. We expect 10 predominantly Hispanic Head Starts and 6
predominantly American Indian Head Starts. Pre-intervention baseline measurements made at
each Head Start center will be used to stratify Head Start centers in each ethnic
subpopulation into lower and upper BMI percentile strata. Random allocation will be used to
assign intervention status in strata defined by BMI and ethnicity.

Once the intervention Head Start centers have been determined, intervention planning will be
conducted with these centers. The interventionists will coordinate efforts to integrate Head
Start staff, community leaders, health providers, and grocery store managers and owners in
the strategic planning process for the intervention. The purpose of this phase is to
establish a collaborative relationship with study participants and to ensure that the
intervention materials and curriculum reflect the cultural context of each community. While
the study team has collectively conducted research in many of the proposed communities, it
is essential to establish a participatory framework that can be sustained throughout the
duration of the study and beyond.

Strategies will include: hands-on food preparation and taste-testing of fruits, vegetables,
and whole grain foods; and story telling, poems, songs, games, crafts, and/or puppets to
reinforce familiar and introduce new fruits, vegetables and whole grain foods. Materials
will be sent home with students so that the intervention activities can be reinforced with
the families.

Head Start staff play a critical role in the intervention. They will receive in-service
training on a quarterly basis designed to prepare and support them in implementing the
classroom curriculum. We anticipate that frequent training for shorter periods of time than
Pathways teacher training will keep the intervention fresh and the content more manageable.
Topics will include the importance of obesity prevention, the role of fruits, vegetables,
and whole grains in maintaining weight and preventing obesity, the role of physical activity
in maintaining weight and preventing obesity, developmentally appropriate physical activity,
and strategies for limiting television viewing and other screen time. Much of the training
will be hands-on and experiential learning, like many of the activities they will be
conducting in the classroom. We will also work with the Head Start program staff to
determine the feasibility of our training sessions contributing to the credentialing process
for Head Start teachers and other staff.

We plan to use a training program for the Head Start cooks of the intervention schools
similar to the successful school food service training program used with the Pathways
intervention. The focus will be on preparing and serving meals that meet the recently
revised Dietary Guidelines for Americans (2005). Annual training sessions will be reinforced
by monthly visits to each intervention Head Start school. Our experience with the Pathways
program suggests that federally mandated nutrition programs (such as the National School
Lunch and School Breakfast Programs) are not necessarily followed precisely at individual
sites, so we will emphasize the Dietary Guidelines and reinforce the NSLP and SBP
requirements during training sessions and follow-up visits to the centers. As with schools
participating in the Pathways program, we anticipate the training sessions and visits will
be met with enthusiasm.

To engage family support and involvement in CHILE, the intervention will include both home-
and Head Start-based activities for families. The home-based component will include
activities that parents can do with their children at home, such as preparing healthful
snacks, taking a walk, and playing active games together. These activities will be
introduced at the Family Events, which will be held four times each year, and will be
re-enforced with take home material. Families will be asked to limit television viewing and
other screen time to 2 hours or less per day. This too will be introduced and re-enforced at
Family Events. Family Events will include such activities as hands-on food preparation and
taste-testing of fruits, vegetables, and whole grain foods, label reading, grocery store
field trips, "Ask the Doctor" (a special one-on-one interaction with a local participating
health care provider), and booths demonstrating concepts and content children are learning
in the classroom.

Inclusion Criteria:

- 3 years of age of beginning of intervention for each cohort (2)

- enrolled in participating Head Start

- informed consent signed by parent or legal guardian

Exclusion Criteria:

- 4 years of age or more at beginning of intervention for each cohort (2)

- not enrolled in a participating Head Start

- informed consent not provided