FirstStep2Health Intervention
Condition: Pediatric Obesity; Risk Reduction Behavior; Early Intervention; Intergenerational Relations
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This project will determine the preliminary efficacy of an innovative intergenerational
      intervention among Head Start preschoolers, aged 3-5 years, and their caregivers. A two-group
      cluster randomized controlled trial will be conducted. Six Head Start centers will be
      randomly assigned to the intervention (n=3) or control group (n=3), and an average of 6
      caregiver-preschooler dyads will be recruited from each class (N=144 dyads from 16 classes).
      Grounded in an Actor-Partner Interdependence Model, the 16-week intervention has 3
      components: 1) a caregiver component, including 1a) a Facebook-based program with weekly
      electronic retrievable flyers providing health information and behavioral change strategies
      and 4 weekly habit-formation tasks to improve parenting practices and home environment for
      preschoolers; and 1b) 3 face-to-face or virtual meetings (weeks 1, 8, & 16) to establish
      personal connections and communication networks among caregivers, discuss strategies, and
      share community resources to support preschoolers' behavioral changes at home; 2) a
      caregiver-preschooler learning component via Facebook messenger to send preschooler letters
      to each caregiver privately by the research team twice per week to 2a) share the
      preschooler's experiences of learning at school and his/her interests for a healthy diet and
      physical activity at home, and 2b) elicit caregivers' response to the letters; and 3) a Head
      Start center-based preschooler component to help preschoolers establish healthy habits via
      weekly healthy diet and physical activity participatory learning.
    

Detailed description: 
      The purpose of this two-group cluster randomized controlled trial is to determine the
      preliminary efficacy of an innovative intergenerational intervention on improving
      preschoolers' moderate-to-vigorous physical activity and diet quality, and decreasing screen
      time, proportion of overweight and obesity, and body mass index z-score among Head Start
      preschoolers (aged 3-5 years) and their caregivers.

      The intervention is guided by an Actor-Partner Interdependence Model, and will target both
      individual-level factors, including knowledge, self-efficacy, and skill, and
      socio-environmental factors, including parental support for child, parenting practices, and
      the home environment. The 16-week intervention has three components: 1) a caregiver component
      including 1a) a Facebook-based program with weekly electronic retrievable flyers providing
      health information and behavioral change strategies, and four weekly habit-formation tasks to
      create a healthier home environment for preschoolers; and 1b) three face-to-face or virtual
      meetings (weeks 1, 8, & 16) to establish personal connections and communication networks
      among caregivers and discuss strategies and share community resources to support behavioral
      changes at home; 2) a caregiver-preschooler learning component via Facebook messenger to send
      preschooler letters to each caregiver privately by the research team twice per week to share
      the preschooler's experiences of learning at school and his/her stated interests for healthy
      diet and physical activity at home, and to ask caregivers to respond to the letters; and 3) a
      Head Start center-based preschooler component to help preschoolers establish healthy habits
      via weekly healthy diet and PA participatory learning.

      From the eligible 13 Head Start centers with at least three classrooms in one Head Start
      organization, six Head Start centers will be randomly selected and assigned to the
      intervention (n = 3) or control (n = 3) group with usual Head Start activities. Three to five
      classes will be randomly selected from each selected Head Start center to be involved in the
      study. In each class, six caregiver-preschooler dyads will be randomly selected from the
      eligible participants, and total 24 caregiver-preschooler dyads will be recruited from each
      center, yielding a total of 144 dyads.

      Three specific AIMS are:

      AIM 1: Determine the preliminary efficacy of FirstStep2Health vs control among preschoolers
      on improving proximal behavioral changes of moderate to vigorous physical activity measured
      by accelerometry (primary outcome); diet quality (e.g., fruits/vegetables, fiber, whole
      grains, total protein, dairy, sugar-sweetened beverages, total sugars/fats), and screen time
      (e.g., watching television, playing video games); and decreasing distal anthropometric
      outcomes of proportion of overweight or obese and body mass index z-score. The investigators
      expect an overall decrease in body mass index z-score in intervention preschoolers because
      overweight or obese preschoolers' body mass index z-score is expected to decrease while
      healthy-weight preschoolers will have no change. The investigators focus on proximal
      behavioral changes as our primary outcome instead of distal anthropometric outcomes due to
      the brevity of this study and the need for behavioral changes to be maintained for at least a
      year before manifesting in changes in anthropometric outcomes.

      AIM 2: Examine the preliminary efficacy of FirstStep2Health vs control among caregivers on
      increasing their moderate to vigorous physical activity measured by accelerometry and diet
      quality; decreasing their screen time, proportion of overweight or obese, and body mass
      index; and improving their knowledge, feeding practice skill, self-efficacy, parental support
      of their child, parenting practices, and home environment.

      AIM 3: Compare FirstStep2Health vs control on the bidirectional relationship between
      preschoolers and caregivers on moderate to vigorous physical activity, diet quality, and
      screen time.

      Further, the investigators will validate established feasibility, acceptability, and
      satisfaction of the intervention using qualitative and quantitative data.

      This study forms the foundation for conducting a future large-scale randomized controlled
      trial to reduce overweight and obesity among low-income preschoolers and their caregivers.
    

Intervention name(s): Caregiver Component.; Caregiver-Preschooler Learning.; Center-based Preschooler Component.
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Facebook-based program including four new habit-formation tasks/week. Three face-to-face or virtual caregiver meetings: Meeting 1: Study orientation and healthy cooking education will be offered, and each family will receive a small bag of groceries to facilitate preparation of a recipe at home. Each caregiver will also receive an intervention cookbook containing affordable slow-cooking recipes, quick-fix recipes, and healthy snack ideas. Meeting 2: Study interveners will demonstrate how to spend less and shop healthy and how to read nutrition fact labels to promote healthy purchasing behaviors. Meeting 3: Study interveners will present healthy eating and PA community resources (e.g., farmer's markets, community gardens, nearly parks or other free or affordable PA facilities) and provide caregivers a resource booklet.; Preschoolers, using stickers, will create two letters each week regarding a food or activity presented in the center-based program that they liked or want to try at home. Letters will be sent by the PM privately to each caregiver via Facebook messenger on two weekdays. Caregivers will be asked to answer two Facebook multiple-choice questions related to the letters each week by Sunday midnight (e.g., what foods listed in the their child's letter did the participant provide? and what activities listed in the their child's letter did the participant's family try?). Caregiver responses to the questions will be summed to indicate caregiver responses to child requests. Each preschooler's letters will be kept in his/her intervention binder with other intervention materials to present to his/her caregiver at Meeting 3. Weekly preschooler activities, with pictures or videos, will be shared with caregivers via the Facebook private group every week.; Built on previous research, preschoolers will receive weekly, age-appropriate, participatory learning co-delivered by teachers and MSU student educators. Session duration will be 20 minutes because children's normal attention span is 3-5 minutes per year of age, and 20 min/session is recommended for preschoolers. The already developed "Eat & Walk My ABCs" curriculum will be implemented. The curriculum includes four components: healthy eating learning, taste-testing activities, movement skill training, and fun physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: From the eligible 13 Head Start centers with at least three classrooms in one Head Start organization, six Head Start centers will be randomly selected and assigned to the intervention (n = 3) or control (n = 3) group with usual Head Start activities. Three to five classes will be randomly selected from each selected Head Start center to be involved in the study. In each class, six caregiver-preschooler dyads will be randomly selected from the eligible participants, and total 24 caregiver-preschooler dyads will be recruited from each center, yielding a total of 144 dyads.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Obesity prevention, early childhood, intergenerational, family-based