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Nutrition PoorNCT03560050

Technical Assistance for Child and Adult Care Food Program in Family Child Care Home

A study testing Nutrition assistance and Children's environmental health/comparison in people with Nutrition Poor and Health Behavior, run by University of Oklahoma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the effect of a nutrition technical assistance training program for family child care home providers on the food they serve young children in their care and the food environment in their home. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Nutrition Poor, Health Behavior
What is being tested?
Nutrition assistance and Children's environmental health/comparison
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
1 Oct 2017to 30 Oct 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Family child care home providers within 60 minutes of Oklahoma City who participate in the Child and Adults Care Food Program

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73117

Other trials in United States

About this study

Official title: Compliance and Technical Assistance for Child and Adult Care Food Program in Family Child Care Homes

This study evaluates the effect of a nutrition technical assistance training program for family child care home providers on the food they serve young children in their care and the food environment in their home. Half the providers will be assigned to the nutrition program and the other half will receive a comparison on environmental health.

Read the detailed description

Early care and education (ECE) providers play a vital role in ensuring that young children have access to nutritious foods. Over 25% of children in ECE (1.2 million children) attend Family Child Care Homes (FCCH). Improvements in the Child and Adult Care Food Program (CACFP) may introduce new barriers for FCCH, which have limited meal preparation capacity. Limited research has examined foods served by FCCH providers, and no group randomized trials have been conducted using a Community-Based Participatory approach in FCCH and including an evaluation of intervention costs.

Goals: 1. Determine compliance of menus and meals provided in FCCH with CACFP guidelines. 2. Determine the effectiveness of a community-based Nutrition Technical Assistance intervention to enhance meeting CACFP best-practices.

Methods: Conduct a cross-sectional assessment of a random sample of FCCH providers' (n=52) menus and meals served. Foods will be evaluated against the CACFP requirements and best-practices. After the cross-sectional examination, providers will be randomly assigned to a Nutrition Technical Assistance (n=26) or attention comparison intervention (n=26). The intervention is based on theoretical foundations and formative interviews, and will consist of two 60-90-minute visits to the FCCH and one group class lasting approximately 3 hours.

Being tested
Nutrition assistance, Children's environmental health/comparison
Keywords
early childhood education, family child care home, food environment
Medical subject headings
Malnutrition, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition assistanceBehavioural

    Participating family child care home providers in and around the Oklahoma City (OKC) area will be randomized to either the Nutrition, or an environmental health comparison group. Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months.

  • Children's environmental health/comparisonBehavioural

    Participating family child care home providers in and around the OKC area will be randomized to either the Nutrition, or an environmental health intervention that will receive an Integrated Pest Management and Green Cleaning intervention with the same format and visit frequency. Briefly, the Intervention will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months.

Study groups in NCT03560050
Study groupRoleWhat they receive
Behavioral: Nutrition assistanceExperimentalthree encounters with Intervention team over three months: two home-based visits for 90 minutes each scheduled at the convenience of the provider and a 3- hour group class session with other providers.
Receives: Behavioral: Nutrition assistance
Behavioral: Children's environmental healthExperimentalthree encounters with Intervention team over three months: two home-based visits for 90 minutes each scheduled at the convenience of the provider and a 3- hour group class session with other providers.
Receives: Behavioral: Children's environmental health/comparison

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Self-reported Nutrition Practices

    Providers report the nutrition environment using the Nutrition and Physical Activity Self Assessment for Child Care (NAPSACC). Scores averaged across items range 0-4. Higher score indicates more desired/healthier outcome.

    Measured: baseline, post 3-months, post 12-months

Secondary outcomes (3)

  1. Provider Nutrition Knowledge

    Self-reported nutrition knowledge using a modified Revised General Nutrition Knowledge Questionnaire. It was reduced in length to 38 items from 88 items. Scores ranged from 0-38 with a higher score indicating greater nutrition knowledge.

    Measured: baseline, post 3-months, post 12-months

  2. Change in Compliance of Menu With Child and Adult Care Food Program Best Practices

    menus are compared to the best practices of the Child and Adult Care Food Program (CACFP). The scale measures the number of elements of the menu which are compliance with the CACFP best practices. The CACFP best Practice compliance tool has a range of 0-25. A higher score is associated with a more desirable outcome and thus higher CACFP best practice compliance.

    Measured: baseline, post 3-months, post 12-months

  3. Change in Children's Dietary Intake of Vegetables at Lunch

    Observation of children's dietary intake on 2 unannounced days using the Dietary Observation in Child Care methods and Food Processor for nutrient analysis. Outcome is cups of vegetables consumed.

    Measured: baseline, post 3-months, post 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2018
  2. Study start1 Oct 2017
  3. Primary completion30 Mar 2019
  4. Study completion30 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized trial where family child care home providers (the participant) are randomized to either nutrition or environmental health technical assistance intervention. Interventions are matched for time and contact
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03560050
Sponsor's protocol ID
7551
Status last verified
May 2026
First submitted
23 May 2018
Last updated
28 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sisson SB, Leidner J, Hall S, Williams BD, Vesely SK, Poe T, Ward DS, Crosscut C, Hildebrand D, Salvatore AL. Three- and Twelve-Month Changes in Child and Adult Care Food Program Best Practices and Preschool Children's Dietary Intake in Family Child Care Homes after the Happy Healthy Homes Randomized Controlled Trial. Child Obes. 2025 Jul;21(5):476-488. doi: 10.1089/chi.2024.0361. Epub 2025 Mar 10.

    PubMed 40059639

  • Sisson SB, Eckart E, Williams BD, Patel SM, Kracht CL, Davis HA, Ward DS, Hildebrand D, Stoner JA, Stinner E, Kerr KE, Salvatore A. Family child care home providers' self-reported nutrition and physical activity practices, self-efficacy, barriers and knowledge: baseline findings from happy healthy homes. Public Health Nutr. 2022 Aug;25(8):2111-2124. doi: 10.1017/S1368980022000337. Epub 2022 Feb 7.

    PubMed 35125128

  • Sisson SB, Salvatore AL, Hildebrand D, Poe T, Merchant C, Slawinski M, Kracht CL, Stoner JA, Alcala Lazarte N, Schneider LAF, Weber J, Jones F, Ward D. Interventions to promote healthy environments in family child care homes in Oklahoma-Happy Healthy Homes: study protocol for a randomized controlled trial. Trials. 2019 Aug 30;20(1):541. doi: 10.1186/s13063-019-3616-9.

    PubMed 31470886

Questions about this trial

What is this clinical trial studying?

A study testing Nutrition assistance and Children's environmental health/comparison in people with Nutrition Poor and Health Behavior, run by University of Oklahoma at 1 site 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 1 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 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 28 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Self-reported Nutrition Practices (time frame: baseline, post 3-months, post 12-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03560050, which also lists 3 linked publications.

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 May 2026.

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