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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04372823
Other study ID # Pro00066175
Secondary ID R01HD093784
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date May 31, 2023

Study information

Verified date February 2023
Source University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years to 4 Years
Eligibility 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 Design


Intervention

Behavioral:
Policy/program
Policy/program to improve nutrition and increase physical activity

Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States University of South Carolina Columbia South Carolina

Sponsors (3)

Lead Sponsor Collaborator
University of South Carolina Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diet 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
Primary Physical activity Accelerometer measured minutes of moderate to vigorous physical activity Approx every year for 2 years
Secondary Body mass index Child body mass index z-score Approx every year for 2 years
Secondary Family child care home environment Environment and Policy Assessment and Observation Approx every year for 2 years
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