Míranos! Program, a Preschool Obesity Prevention RCT
Condition: Obesity; Healthy Eating; Physical Activity; Health Knowledge, Attitudes, Practice; Gross Motor Development
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The prevalence of obesity remains high in American children aged 2-5 while one in three Head
      Start children is overweight or obese. The proposed study is designed to test the efficacy of
      an early childhood obesity prevention program which promotes healthy growth in predominantly
      Latino children in Head Start.

      The program is a group clustered randomized controlled trial in partnership with two local
      Head Start organizations to address key enablers and barriers in obesity prevention in young
      children. The study has three specific aims:

        1. To test the efficacy of the Miranos! intervention on healthy weight growth (primary
           outcome) in normal weight, overweight, and obese children.

        2. To test the impact of the Miranos! intervention on children's physical activity,
           sedentary behavior, sleep, and dietary behaviors (secondary outcomes).

        3. To evaluate cost-effectiveness of the Miranos! intervention.

      Miranos! will be delivered in Fall and Spring (8 months) and followed by a summer health
      campaign.
    

Detailed description: 
      Using a three-arm design, 12 Head Start (HS) centers in equal number will be randomly
      assigned to one of three conditions: 1) a combined center- and home-based intervention, 2)
      center-based intervention only, or 3) active control. The interventions will be delivered
      during the academic year (an 8-month [mo] period). A total of 525 3-year-old children (52%
      females; in two cohorts) will be enrolled in the study at baseline and followed prospectively
      one-year post-intervention. The first cohort will be recruited in summer 2018. The second
      cohort will be recruited in summer 2019.

      Data collection will be conducted at baseline (T0), immediate post-intervention (T1), and
      1-year post-intervention follow-up (T2) and include children's height, weight,
      accelerometry-based PA and sedentary behavior, TV watching and sleep by parent reports, gross
      motor development, dietary intakes, food preference. Information on family background,
      parental PA- and nutrition-related practices, parental weight and health behaviors, PA and
      nutrition policies and environments at the center and home, and costs associated with
      intervention delivery will be collected. The primary endpoint for the study is the BMI at the
      posttest immediately following the completion of the intervention (T1).

      Recruitment: Participant recruitment will take place during summer by sending a recruitment
      packet to child's home. This packet includes: study information sheet, recruitment flyer,
      informed consent form, a letter from center director and study PIs.

      Process Evaluation: The process evaluation is informed by the NIH Behavior Change Consortium
      Treatment Fidelity Workgroup's best practice recommendations and recent multi-component RCTs.
      Míranos! has multiple components with multiple activities, the investigators will use many
      indicators to evaluate the fidelity and completeness of the implementation of all components
      and determine contribution of each component by linking it to the primary and secondary
      outcomes. The investigators will collect both quantitative/qualitative data to assess
      cross-site treatment consistency, non-treatment-related effects, and document protocol
      changes.

      First, intervention dose delivered will be measured by: 1) pre-/post-study center
      environmental assessment by the Environment and Policy Assessment and Observations (EPAO) and
      auditing of meal menus; 2) completion of delivery schedule of staff, peer leader training,
      parent education sessions, home visits; 3) evaluation of staff, peer leader training; 4)
      monthly auditing of weekly lesson plans; and 5) monthly checklist of use of Míranos! Activity
      Cards, children's story books, HHL learning activities.

      Second, the intervention dose received will be assessed by: 1) attendance records of staff,
      peer leader training, parent education sessions; 2) certification test of staff, peer leader
      training; 3) monthly staff evaluation (rating scale) of children's learning of HHL content,
      gross motor skills, eating behaviors; 4) post-study parent intercept interviews; and 5)
      post-study focus groups on program delivery process with staff (n=24) and parents (n=32).

      Third, participants' responses to the intervention will be evaluated by: 1) random
      observations of staff behavior (rating scale) during outdoor play and lunch by research
      staff; 2) assessments on children's PA by the System for Observing Fitness Instruction Time
      for Preschoolers and diet by group plate waste test in 3 randomly selected centers; 3)
      in-depth interviews with staff (n=48) for program feedback; and 4) post-study staff and
      parent evaluation (rating scale) of satisfaction with intervention components/activities.
    

Intervention name(s): Center-based Intervention; Home-based Intervention; Active Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Center nutrition and physical activity policy modification to increase fruit and vegetable servings and more physical activity throughout the day
Staff training and technical assistance
Health education on healthy habits (diet, physical activity, sleep, screen time) using the Sesame Workshop Healthy Habits for Life (HHL) resource kit
Health contests
Gross motor and physical activity program
Miranos! activity cards based on children storybooks; Monthly interactive poster education sessions led by parent peer educators during child pick-up time. Held at Head Start Center. These sessions include family health challenges and take-home activities.
Three Home Visits delivered by Head Start staff. Obesity prevention goal-setting integrated into existing Head Start home visits
16 semi-monthly, Family Newsletters with stories, tips, and strategies to promote healthy habits for preschool children
Incorporating activities related to PA, nutrition and sleep into existing Head Start Center Summer Calendars; Children will receive Head-Start-approved health education program for children: "I Am Moving, I Am Learning". In addition, the investigators will deliver an early childhood literacy program to all active control children to increase buy-in and retention.
Other intervention name(s): CBI; C+HBI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention