Diet, HealthyFCCHNCT04372823
Promoting Nutrition and Physical Activity in Family Child Care
An observational study of Diet, Healthy and Physical Activity, run by University of South Carolina at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Diet, Healthy, Physical Activity, Obesity, Childhood
- What is being tested?
- Policy/program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2017to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Study population: Family child care homes located in South Carolina and children ages 2-4 years enrolled in those homes.
Who may be able to join
- 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
Who cannot join
- Family planning to leave the care arrangement in next few years
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21218
University of South Carolina
Columbia, South Carolina, 29208
About this study
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.
Read the 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.
- Conditions
- Diet, Healthy, Physical Activity, Obesity, Childhood
- Being tested
- Policy/program
- Medical subject headings
- Motor Activity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Policy/programBehavioural
Policy/program to improve nutrition and increase physical activity
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Policy/program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Approx 1 year
Physical activity
Accelerometer measured minutes of moderate to vigorous physical activity
Measured: Approx every year for 2 years
Secondary outcomes (2)
Body mass index
Child body mass index z-score
Measured: Approx every year for 2 years
Family child care home environment
Environment and Policy Assessment and Observation
Measured: Approx every year for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start1 Oct 2017
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Russell Pate, University of South Carolina
- Investigators
- Russell R Pate, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372823
- Sponsor's protocol ID
- Pro00066175
- Other IDs
- R01HD093784
- Acronym
- FCCH
- Status last verified
- Mar 2025
- First submitted
- 29 Apr 2020
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Nutrition and Physical Activity in Family Child Care
- ClinicalTrials.gov ID
- NCT04372823
- Acronym / sponsor ID
- FCCH / Pro00066175
- Conditions
- Diet, Healthy, Physical Activity, Obesity, Childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison | – | –Comparison children within family child care homes not exposed to policy/program |
| Intervention | – | Behavioral: Policy/programIntervention children within family child care homes exposed to policy/program |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Family child care homes located in South Carolina and children ages 2-4 years enrolled in those homes.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Family planning to leave the care arrangement in next few years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Policy/programPolicy/program to improve nutrition and increase physical activity | Behavioural | Intervention |
Primary outcome
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).
Physical activity
Time frame: Approx every year for 2 years
Accelerometer measured minutes of moderate to vigorous physical activity
2 secondary outcomes
Body mass index
Time frame: Approx every year for 2 years
Family child care home environment
Time frame: Approx every year for 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell R Pate principal investigator
University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet, Healthy and Physical Activity, run by University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet (time frame: Approx 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.