Promoting Nutrition and Physical Activity in Family Child Care (FCCH)

March 24, 2025 updated by: Russell Pate, University of South Carolina
The CHEER study takes advantage of a natural experiment happening in South Carolina (SC). The South Carolina Department of Social Services implemented new healthy eating and physical activity standards through a state-wide policy for family child care homes that participate in the ABC Grow Healthy program. Thus, CHEER is a quasi-experimental, two-group, pre-test/post-test design study.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The overall goal of the study is to evaluate new healthy eating and physical activity standards targeting family child care homes in South Carolina. To accomplish this goal, we are assessing the effects of the standards on the dietary intake and physical activity levels of racially diverse low-income children in family child care homes. The specific aims of the "CHEER" study are as follows:

Aim 1. Evaluate the extent to which the new regulatory standards impact children's dietary intake assessed via direct observation in homes and 24-hour recalls with parents, and physical activity and sedentary behavior assessed via accelerometry.

Aim 2. Evaluate the extent to which the new regulatory standards impact children's body mass index computed from researcher-measured height and weight.

Secondary Aim. Evaluate the extent to which family child care homes in the SC ABC Child Care Program comply with the new healthy eating and physical activity regulatory standards, compared to family child care homes not participating in the program.

We hypothesize that most homes will comply with the new standards, yielding improvements in children's healthy eating and physical activity levels. As an exploratory aim, we will examine the effects of the standards on children's weight status.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Johns Hopkins University
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 4 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Family child care homes located in South Carolina and children ages 2-4 years enrolled in those homes.

Description

Inclusion Criteria:

  • Having a child in care between the ages 2 and 4 years at recruitment
  • The family is planning to stay in the same care arrangement for the next few years

Exclusion Criteria:

  • Family planning to leave the care arrangement in next few years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Comparison
Comparison children within family child care homes not exposed to policy/program
Intervention
Intervention children within family child care homes exposed to policy/program
Policy/program to improve nutrition and increase physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diet
Time Frame: Approx 1 year
Healthy Eating Index score - The Healthy Eating Index is a calorie-adjusted comparison of individual or group-level dietary intake to current dietary guidelines. The Healthy Eating Index was last updated in 2015 and represents the sum of thirteen component scores. Higher scores are awarded for healthier intake within each component. Each component of the Healthy Eating Index has a standard for receiving the minimum or maximum points possible. The HEI components and maximum scores include: total fruit (5), whole fruit (5), total vegetables (5), greens and beans (5), whole grains (10), dairy (10), total proteins (5), seafood/plant (lean) proteins (5), fatty acids (10), refined grains (10), sodium (10), added sugars (10), and saturated fats (10).
Approx 1 year
Physical activity
Time Frame: Approx every year for 2 years
Accelerometer measured minutes of moderate to vigorous physical activity
Approx every year for 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: Approx every year for 2 years
Child body mass index z-score
Approx every year for 2 years
Family child care home environment
Time Frame: Approx every year for 2 years
Environment and Policy Assessment and Observation
Approx every year for 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Russell R Pate, University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00066175
  • R01HD093784 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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