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NCT02697565 · ClinicalTrials.gov registry record · NA
Healthy Caregivers-Healthy Children (HC2) Phase II
A NA study, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 2,289
- Enrollment target
NCT02697565: Completed NA study, sponsored by University of Miami.
NCT02697565 is a NA study that has completed, run by University of Miami. The registered enrollment target is 2,289 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02697565, a NA study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,289 participants
- Enrollment target
Study Summary
One in four U.S. children under the age of 5 years old are either overweight or obese with ethnic-minority children being disproportionately affected. Low-income preschool children, many from ethnic minority backgrounds, receive childcare in federal/state subsidized centers where daily meals are provided. Nationally, the Quality Rating and Improvement Systems (QRIS) organization is responsible for rating the quality of childcare centers. However, nutrition and physical activity policy standards have not been incorporated into QRIS childcare center policies. Therefore, the goal of this project is to address the 2014 AFRI program area priority of Childhood Obesity Prevention by building on the phase I "Healthy Caregivers, Healthy Children (HC2)" NRI/AFRI funded project (2010-2013), in partnership with the Miami Dade County Cooperative Extension team, to evaluate the program via randomized-controlled trial outcomes, and deliver an evidence-based effective childcare center-based program/toolkit. This project (phase II) will expand HC2 Phase I findings by transferring the evidence-based HC2 program/toolkit to QRIS childcare centers via a train-the-trainers (TTT) model. The following specific aims are proposed; (1) to evaluate the TTT model of delivery for the evidence-based HC2 toolkit's effectiveness versus an attention control on parent and teacher adoption of healthy lifestyle role modeling behaviors, and policy integration; (2) to evaluate the impact of a TTT delivery model versus an attention control on child body composition and short- and long-term behavioral health outcomes, and (3) to disseminate the HC2 early childhood obesity prevention toolkit TTT model within the QRIS early childhood network at the Miami Dade County-level.
Primary Outcome
The EPAO will examine childcare center environmental changes. The EPAO will assess the level of implementation of the snack, screen time, physical activity, and beverage policies through direct observation of diet and physical activity. Child health behaviors and parent and teacher health behaviors will also be measured.
Interventions
- BEHAVIORAL Healthy Caregivers- Healthy Children Toolkit
- BEHAVIORAL Safety Curriculum
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,289 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-03 |
| Phase | NA |
What the finished NCT02697565 record still lists
NCT02697565 is an interventional study that assigns participants to a tested intervention. Its 2,289 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 2 interventions - of which Healthy Caregivers- Healthy Children Toolkit is the first listed.
NCT02697565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02697565 about?
NCT02697565 is a clinical study titled "Healthy Caregivers-Healthy Children (HC2) Phase II". One in four U.S. children under the age of 5 years old are either overweight or obese with ethnic-minority children being disproportionately affected. Low-income preschool children, many from ethnic minority backgrounds, receive childcare in federal/state subsidized centers where daily meals are pro...
What is the current status of trial NCT02697565?
This trial is currently completed. It is a NA study. The enrollment target is 2,289 participants. The study started on 2015-04. Estimated completion is 2019-03.
What interventions are being tested in trial NCT02697565?
The interventions under investigation include: Healthy Caregivers- Healthy Children Toolkit (BEHAVIORAL), Safety Curriculum (BEHAVIORAL).
Who is sponsoring clinical trial NCT02697565?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02697565's enrollment target sits among peer trials
2,289 48th of 2000 higher than 1,953 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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