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Healthy Caregivers-Healthy Children (HC2) Phase II

Primary Purpose

Pediatric Obesity, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Caregivers- Healthy Children Toolkit
Safety Curriculum
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Obesity focused on measuring childhood obesity, obesity, prevention, nutrition, health, preschool, childcare, role model, pediatric obesity, weight, overweight, early childhood, train the trainer

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • QC centers must meet the following criteria to be included: (1) have > 30 children ages 2-5 enrolled; (2) Serve low income families; (3) be a part of the USDA food program and Supplemental Nutrition Assistance Program (SNAP) eligible; (3) Reflect the ethnic diversity of the MDC Public School System (63 percent Hispanic, 19 percent African American, 18 percent white); and (4) Center directors agree to participate and sign a letter of commitment (see Documents of Collaboration).

Exclusion Criteria:

  • Centers with a high prevalence of special needs children.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Train-the-Trainers Arm

Attention Control Arm

Arm Description

Intervention Arm receives the Healthy Caregivers- Healthy Children Toolkit (healthy lifestyle role modeling intervention) via a nutritional gate keeper. The toolkit reinforces center health and activity policy standards.

Control Arm that receives an attention control safety curriculum.

Outcomes

Primary Outcome Measures

Change in The Environment and Policy Assessment and Observation tool (EPAO) score
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.

Secondary Outcome Measures

Observed pre-post maintenance on Child's Body Mass Index (BMI)
BMI is based on height and weight of the child as per CDC guidelines
Change of caregiver role modeling behavior
The HC2 self assessment tool has a role modeling scale, measuring role modeling behavior

Full Information

First Posted
December 21, 2015
Last Updated
March 5, 2019
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02697565
Brief Title
Healthy Caregivers-Healthy Children (HC2) Phase II
Official Title
Healthy Caregivers-Healthy Children (HC2) Phase II: Integrating Culturally Sensitive Childhood Obesity Prevention Strategies Into Policy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
While all states are responsible for childcare licensing standards, 26 states serving over 1 million preschool-age children currently implement QRIS. In MDC, QRIS-affiliated childcare facilities (collectively called Quality Counts or QC centers from this point forward) provide care to 1/3 of MDC's preschool-age children (80% are ethnic minorities) in 417 centers. At this time there are no nutrition policies included in the QRIS standards for childcare centers. Therefore, in light of the current childhood obesity epidemic, this project will address a major gap in knowledge and the disparities in access to healthy food consumption in the childcare center setting through HC2 implementation. This study builds on previously funded work and will maximize the initial 3-year (2010-2013) investment the USDA made in phase I of the project to test effective obesity prevention strategies in the early childhood setting utilizing both educators and parents as nutritional gatekeeper, healthy lifestyle role models for 2-to-5 year-old children. The goal of this proposed project (phase II) is to expand the phase I evidence-based HC2 findings by giving ownership of the program/toolkit to the childcare centers via a train-the-trainers model and by implementing nutrition and physical activity standards into the Quality Rating Improvement System. The proposed integrated project is responsive to the USDA's National Institute of Food and Agriculture (formerly CSREES) functions by addressing all three areas of the agricultural knowledge system, including (1) a scientifically-based and rigorous Research design that assesses obesity prevention efforts with young children in a novel setting of childcare facilities; (2) the development of an Educational tool kit to improve training and capacity of teachers and parents/families. Extension and capacity building will be enhanced through HC2 toolkits delivered to the centers and train-the-trainer program manuals for use throughout the QRIS network and in cooperation with Florida FNP. Finally, by incorporating HC2 practices into permanent QRIS policy, centers can sustain the project's benefits for future children, teachers, and families. Additionally, the investigators will collaborate with two community nutritionists to provide services to a large number of childcare centers in the county therefore, extending project materials. Lastly, the toolkit will sustain education and extension functions beyond the life of the project by giving ownership of HC2 to the childcare centers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Obesity
Keywords
childhood obesity, obesity, prevention, nutrition, health, preschool, childcare, role model, pediatric obesity, weight, overweight, early childhood, train the trainer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2289 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Train-the-Trainers Arm
Arm Type
Experimental
Arm Description
Intervention Arm receives the Healthy Caregivers- Healthy Children Toolkit (healthy lifestyle role modeling intervention) via a nutritional gate keeper. The toolkit reinforces center health and activity policy standards.
Arm Title
Attention Control Arm
Arm Type
Other
Arm Description
Control Arm that receives an attention control safety curriculum.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Caregivers- Healthy Children Toolkit
Intervention Description
The treatment arm will receive the train-the-trainer model (utilizing Quality Counts coaches) to deliver the evidence- based HC2 toolkit.
Intervention Type
Behavioral
Intervention Name(s)
Safety Curriculum
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in The Environment and Policy Assessment and Observation tool (EPAO) score
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Observed pre-post maintenance on Child's Body Mass Index (BMI)
Description
BMI is based on height and weight of the child as per CDC guidelines
Time Frame
2 years
Title
Change of caregiver role modeling behavior
Description
The HC2 self assessment tool has a role modeling scale, measuring role modeling behavior
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: QC centers must meet the following criteria to be included: (1) have > 30 children ages 2-5 enrolled; (2) Serve low income families; (3) be a part of the USDA food program and Supplemental Nutrition Assistance Program (SNAP) eligible; (3) Reflect the ethnic diversity of the MDC Public School System (63 percent Hispanic, 19 percent African American, 18 percent white); and (4) Center directors agree to participate and sign a letter of commitment (see Documents of Collaboration). Exclusion Criteria: Centers with a high prevalence of special needs children.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruby Natale, PhD, PsyD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

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Healthy Caregivers-Healthy Children (HC2) Phase II

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