Child Health Initiative for Lifelong Eating and Exercise (CHILE)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Child Health Initiative for Lifelong Eating and Exercise (CHILE) is a trans-community
      multidisciplinary site-specific intervention and evaluation plan for a Head Start and
      family-based culturally and developmentally appropriate intervention. The primary goals are
      to increase physical activity and improve dietary intake through increased consumption of
      fruits, vegetables and whole grain and decrease consumption of sweetened drinks and high-fat
      foods,decrease television and other screen time, and decrease obesity in three to five year
      old Hispanic and American Indian children enrolled in Head Start programs in rural New
      Mexico. The trans-community intervention includes: A classroom curriculum for children; an
      in-service training program for Head Start teachers and educational aides; a school food
      service component; a family intervention; a community leader/local health care provider
      component; and a grocery store component.

      Participants include 16 Head Start programs serving Hispanic and Native American children and
      families from underserved communities in rural New Mexico. This is a randomized trial with an
      Intervention Condition and Control Condition. One cohort of three-year old Head Start
      students will be followed and measured for two years. During the two years in Head Start
      those children, their teachers, and families enrolled in the Intervention Condition will
      receive a program of activities to modify their dietary, physical activity, and screen
      viewing behaviors. Also addressed are the Head Start and community environments and policies,
      local grocery stores, and health care providers.

      CHILE uses an ecological framework including social cognitive theory, intervention mapping,
      environmental and policy changes, developmental theory, and sound educational practices. The
      approach includes in from the community to ensure acceptability, cultural appropriateness,
      feasibility, sustainability, and later transferability to similar communities.

      The primary outcome measures include changes in physical activity levels, dietary fiber
      intake, dietary fat intake, intake of sugared drinks, television viewing and other screen
      time, in BMI. Secondary measures include changes in the Head Start and community environments
      and policies related to physical activity, school food service, school snacks, and
      availability of healthful options. We will also examine the role of community leaders,
      especially health care providers, in raising awareness and creating a supportive and
      sustainable environment for the prevention of obesity.
    

Detailed description: 
      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.
    

Intervention name(s): classroom curriculum; In-service training for Head Start teachers/aides; Training for Head Start food service; Family intervention component; Food source; Health care providers; CHILE Head Start Intervention
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): classroom curriculum for 3 & 4 year old children includes activities to increase intake of fruits, vegetables, & whole grains; increase physical activity; decrease intake of fats and sugared drinks; and decrease screen time following monthly learning modules.
Teachers are trained to carry out the classroom curriculum.; Teachers and teacher aides are trained quarterly by certified trainers and receive a certificate for participating in the training. Topics include the content as well as developmental concepts.; Food service workers are trained (quarterly) to modify food ordering, food preparation, and food serving to match the aims of the study; Families receive the CHILE intervention quarterly at Family Events. These include family activities to increase intake of fruits, vegetables, whole grains, decrease intake of fats and sugared drinks, increase of physical activity and decrease screen time. Parenting skills are also included.; The grocery store component includes field trips, self labeling, and taste testing of promoted foods.; The health care provider component includes the health care providers presenting at the Family Events and reinforcing the CHILE intervention message in the practice setting when talking with families of head start children.; There are six components of this transcommunity social-ecological intervention including a classroom curriculum, health care provider component, family component, training of Head Start teachers/aides, training of food service staff and grocery store component.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: body composition; physical activity; dietary intake; children