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NCT04164277 · ClinicalTrials.gov registry record · NA
FirstStep2Health Intervention
A NA study, sponsored by Michigan State University.
- Completed
- Registry status
- NA
- Development phase
- 95
- Enrollment target
NCT04164277: Completed NA study, sponsored by Michigan State University.
NCT04164277 is a NA study that has completed, run by Michigan State University. The registered enrollment target is 95 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04164277, a NA study, has completed, sponsored by Michigan State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 95 participants
- Enrollment target
Study 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.
Primary Outcome
The ActiGraph GT3X accelerometer (www.theactigraph.com) will record acceleration counts from which minutes of MVPA per day will be estimated (analysis software available). Each caregiver-preschooler dyad will receive the accelerometers at the same time and data collectors will explain to both caregiver and preschooler how to wear the accelerometers. Preschoolers' caregivers will be instructed to return monitors either at the Head Start center or via mail using using the provided prepaid envelope
Interventions
- BEHAVIORAL Caregiver Component.
- BEHAVIORAL Caregiver-Preschooler Learning.
- BEHAVIORAL Center-based Preschooler Component.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2021-09-20 |
| Est. Completion | 2023-08-31 |
| Phase | NA |
What the finished NCT04164277 record still lists
NCT04164277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Caregiver Component. is the first listed.
NCT04164277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04164277 about?
NCT04164277 is a clinical study titled "FirstStep2Health Intervention". 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 interve...
What is the current status of trial NCT04164277?
This trial is currently completed. It is a NA study. The enrollment target is 95 participants. The study started on 2021-09-20. Estimated completion is 2023-08-31.
What interventions are being tested in trial NCT04164277?
The interventions under investigation include: Caregiver Component. (BEHAVIORAL), Caregiver-Preschooler Learning. (BEHAVIORAL), Center-based Preschooler Component. (BEHAVIORAL).
Who is sponsoring clinical trial NCT04164277?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04164277's enrollment target sits among peer trials
95 931st of 2000 higher than 1,066 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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