CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,289 enrolled
Drug / intervention
Healthy Caregivers- Healthy Children Toolkit +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02697565
NCT02697565N/ACompleted

Healthy Caregivers-Healthy Children (HC2) Phase II: Integrating Culturally Sensitive Childhood Obesity Prevention Strategies Into Policy

University of Miami·interventional·Posted Mar 3, 2016·Updated Mar 7, 2019

In Brief

A clinical study evaluating Healthy Caregivers- Healthy Children Toolkit and Safety Curriculum for Pediatric Obesity and Obesity. Completed, enrolled 2,289 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 3, 2016
Enrollment StartApr 1, 2015
Primary CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.3 years ago

Interventions

Healthy Caregivers- Healthy Children Toolkitbehavioral

The treatment arm will receive the train-the-trainer model (utilizing Quality Counts coaches) to deliver the evidence- based HC2 toolkit.

Safety Curriculumbehavioral

Centers randomized to the control arm will receive an attention control consisting of three visits from 'Safety Sam,' a character and safety curriculum that was fully developed and implemented in phase I of HC2. The same delivery model (train-the-trainers utilizing Quality Counts coaches) will be implemented.