FCCH: Promoting Nutrition and Physical Activity in Family Child Care

Sponsor

University of South Carolina (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04372823

Collaborator

Johns Hopkins University (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

300

Enrollment

Locations

55.9

Anticipated Duration (Months)

150

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diet, Healthy Physical Activity Obesity, Childhood	Behavioral: Policy/program

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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Promoting Nutrition and Physical Activity in Family Child Care

Actual Study Start Date :

Oct 1, 2017

Anticipated Primary Completion Date :

May 30, 2022

Anticipated Study Completion Date :

May 30, 2022

Arms and Interventions

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

Arm

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

Behavioral: Policy/program

Policy/program to improve nutrition and increase physical activity

Outcome Measures

Primary Outcome Measures

Diet [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).
Physical activity [Approx every year for 2 years]
Accelerometer measured minutes of moderate to vigorous physical activity

Secondary Outcome Measures

Body mass index [Approx every year for 2 years]
Child body mass index z-score
Family child care home environment [Approx every year for 2 years]
Environment and Policy Assessment and Observation

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 4 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21218
2	University of South Carolina	Columbia	South Carolina	United States	29208

Sponsors and Collaborators

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

Investigators

Principal Investigator: Russell R Pate, University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Russell Pate, Professor, University of South Carolina

ClinicalTrials.gov Identifier:

NCT04372823

Other Study ID Numbers:

Pro00066175
R01HD093784

First Posted:

May 4, 2020

Last Update Posted:

Sep 28, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pediatric Obesity

Study Results

No Results Posted as of Sep 28, 2021