N/A
N=95
FirstStep2Health Intervention
Pediatric Obesity · Risk Reduction Behavior · Early Intervention · Intergenerational Relations
Bottom Line
View on ClinicalTrials.gov: NCT04164277 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Moderate-to-vigorous Physical Activity (MVPA; Preschoolers)-AIM 1 — 7.51; 7.46 Minutes per hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Caregiver Component. (Behavioral); Caregiver-Preschooler Learning. (Behavioral); Center-based Preschooler Component. (Behavioral)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Michigan State University
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Moderate-to-vigorous Physical Activity (MVPA; Preschoolers)-AIM 1 |
7.51; 7.46 | — |
| SECONDARY Fruit/Vegetable Intake (Preschoolers)-AIM 1 |
3.60; 3.61 | — |
| SECONDARY Screen Time (Preschoolers)-AIM 1 |
3.70; 3.58 | — |
| SECONDARY Number of Preschoolers Who Are Overweight or Obese-AIM 1 |
14; 12 | — |
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.
Eligibility Criteria
Inclusion Criteria. There are ten inclusion criteria (five for preschoolers and five for caregivers).
Preschoolers must:
- Have parental consent.
- Have child assent if the child is 5 years old.
- Be 3-5 years of age. The investigators prioritize this age group because intervening with preschoolers before age 5 results in better short- and long-term weight reduction outcomes than with children older than 5; and children who are at least 3 years-old have the motor and cognitive development to participate in a healthy eating and physical activity curriculum.
- Be able to understand and speak English. The intervention will be delivered in English.
- Be enrolled in the full-day or part-day Head Start program. Head Start offers part-day and full-day programs. To increase the generalizability of the study findings, preschoolers from both full-day and part-day programs will be recruited in this study.
Caregivers must:
- Provide consent.
- Be the primary adult caregiver (≥ 18 years old) for the preschooler. Primary caregiver refers to the one person most responsible for providing care to the preschooler on a daily basis.
- Be able to read, understand, and speak English. The intervention will be delivered in English.
- Have at least weekly Internet access using a smartphone, tablet, or a computer. Each caregiver needs to have Internet access to access the study Facebook site for participating in the Facebook-based program.
- Be willing to use Facebook. Since the caregiver intervention component will be delivered via Facebook, caregivers need to be willing to use Facebook in the study.
Exclusion Criteria. There are three exclusion criteria for both caregivers and preschoolers.
- Preschoolers or caregivers who have medical conditions precluding participating in dietary changes or physical activity.
- Preschoolers or caregivers who have diagnosed health conditions known to impact weight (e.g., Prader-Willi Syndrome) or are taking weight-affecting medications (e.g., stimulants).
- Preschoolers who have diagnosed developmental disabilities (e.g., autism), or caregivers who have diagnosed psychiatric or mental health problems.
Data sourced from ClinicalTrials.gov (NCT04164277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.