- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04372823
Promoting Nutrition and Physical Activity in Family Child Care (FCCH)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21218
- Johns Hopkins University
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South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Comparison
Comparison children within family child care homes not exposed to policy/program
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Intervention
Intervention children within family child care homes exposed to policy/program
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Policy/program to improve nutrition and increase physical activity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diet
Time Frame: Approx 1 year
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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).
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Approx 1 year
|
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Physical activity
Time Frame: Approx every year for 2 years
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Accelerometer measured minutes of moderate to vigorous physical activity
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Approx every year for 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body mass index
Time Frame: Approx every year for 2 years
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Child body mass index z-score
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Approx every year for 2 years
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Family child care home environment
Time Frame: Approx every year for 2 years
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Environment and Policy Assessment and Observation
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Approx every year for 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Russell R Pate, University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00066175
- R01HD093784 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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