Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Early Intervention
  • Intergenerational Relations
  • Pediatric Obesity
  • Risk Reduction Behavior
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: From the eligible 13 Head Start centers with at least four 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. Four 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)Masking Description: Data collectors and interviewers will be blinded to the randomization.Primary Purpose: Prevention

Participation Requirements

Age
Between 3 years and 5 years
Gender
Both males and females

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 obes...

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 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 four 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. Four 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.

Tracking Information

NCT #
NCT04164277
Collaborators
Not Provided
Investigators
Not Provided