- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03560050
Technical Assistance for Child and Adult Care Food Program in Family Child Care Home
Compliance and Technical Assistance for Child and Adult Care Food Program in Family Child Care Homes
Study Overview
Status
Conditions
Intervention / Treatment
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 pilot community-based Nutrition Technical Assistance intervention to enhance meeting CACFP best-practices. 3. Determine the effectiveness of a statewide community-based Nutrition Technical Assistance Intervention to enhance meeting CACFP best-practices. 4. Expand university student opportunities for participation in health research.
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 in the pilot will be randomly assigned to a Nutrition Technical Assistance (n=26) or attention comparison intervention (n=26). Following the pilot, trained Extension Educators will implement both interventions (n=27 intervention, n=27 comparison) in six selected counties, reaching underserved rural and low-income populations. 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
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Oklahoma City, Oklahoma, United States, 73117
- University of Oklahoma Health Sciences Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Family child care home providers within 60 minutes of Oklahoma City who participate in the Child and Adults Care Food Program
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral: Nutrition assistance
three 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.
|
Participating family child care home providers in and around the Oklahoma City (OKC) area will be randomized to either the Nutrition (n=26), or an environmental health comparison group (n=26).
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.
|
Experimental: Behavioral: Children's environmental health
three 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.
|
Participating family child care home providers in and around the OKC area will be randomized to either the Nutrition (n=26), or an environmental health intervention (n=26) 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-reported nutrition practices
Time Frame: baseline, post 3-months, post 12-months
|
Providers report the frequency of fruit and vegetables, milk, and salty snacks served
|
baseline, post 3-months, post 12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Provider knowledge and self efficacy
Time Frame: baseline, post 3-months, post 12-months
|
providers will self report nutrition and environmental health knowledge and self efficacy
|
baseline, post 3-months, post 12-months
|
Change in Environmental health observation
Time Frame: baseline, post 3-months, post 12-months
|
observation of household cleaners and chemicals and signs of pests
|
baseline, post 3-months, post 12-months
|
Change in nutrition environment using the Environment and Policy Assessment Observation
Time Frame: baseline, post 3-months, post 12-months
|
observation of food environment during lunch on 2 unannounced days
|
baseline, post 3-months, post 12-months
|
Change in compliance of menu and meal with Child and Adult Care Food Program
Time Frame: baseline, post 3-months, post 12-months
|
menus and meals are compared to the requirements and best practices of the CACFP
|
baseline, post 3-months, post 12-months
|
Change in children's dietary intake
Time Frame: baseline, post 3-months, post 12-months
|
observation of children's dietary intake on 2 unannounced days
|
baseline, post 3-months, post 12-months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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 Feb 7:1-14. doi: 10.1017/S1368980022000337. Online ahead of print.
- 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.
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
- 7551
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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