Healthy Caregivers-Healthy Children (HC2) Phase II

NCT ID: NCT02697565

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2289 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-03-31

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.

Conditions

Pediatric Obesity; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Train-the-Trainers Arm

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.

Group Type: EXPERIMENTAL

Healthy Caregivers- Healthy Children Toolkit

Intervention Type: BEHAVIORAL

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

Attention Control Arm

Control Arm that receives an attention control safety curriculum.

Group Type: OTHER

Safety Curriculum

Intervention Type: BEHAVIORAL

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.

Interventions

Healthy Caregivers- Healthy Children Toolkit

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

Intervention Type: BEHAVIORAL

Safety Curriculum

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Ruby Natale

Associate Professor of Clinical Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruby Natale, PhD, PsyD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

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Other Identifiers

2015-68001-23232

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20140876

Identifier Type: -

Identifier Source: org_study_id