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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04345874
Other study ID # 10747
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date December 7, 2021

Study information

Verified date May 2022
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the effect of a fully virtual 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 randomly assigned to the nutrition program and the other half will receive a comparison on environmental health.


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 the effectiveness of a virtual, rural outreach 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=54) menus and meals served. Foods will be evaluated against the CACFP requirements and best-practices. Trained Extension Educators will implement both interventions (n=27 intervention, n=27 comparison) focused in rural counties, reaching underserved rural and low-income populations. The intervention is based on theoretical foundations and formative interviews, and will consist of two virtual 60-90-minute one-on-one visits with the FCCH and one virtual group class lasting approximately 3 hours.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date December 7, 2021
Est. primary completion date December 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Family Child Care Home Providers who participate in the Child and Adult Care Food Program in Oklahoma. - Providers must serve at least 1 2-to-5 year old child and speak English. - Providers must plan to continue their business while participating in CACFP for the next 12 months. Exclusion Criteria: - Family Child Care Home Providers who care for only infants and toddlers and not speak English. - Participant withdraws.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nutrition technical assistance
Participating family child care home providers in rural counties will be randomized to either the Nutrition Intervention (n=27), or an environmental health comparison group (n=27) that will receive an Integrated Pest Management and Green Cleaning intervention with the same format and visit frequency. Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with our intervention team: two 60-90 minutes virtual one-on-one visits scheduled at the convenience of the family child care home provider and a 3-hour virtual group class session with other providers. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention virtually over a period of three months.
Children's environmental health technical assistance
Participating family child care home providers in rural counties will be randomized to either the Nutrition Intervention (n=27), or an environmental health comparison group (n=27) that will receive an Integrated Pest Management and Green Cleaning intervention with the same format and visit frequency. Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with our intervention team: two 60-90 minutes virtual one-on-one visits scheduled at the convenience of the family child care home provider and a 3-hour virtual group class session with other providers. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention virtually over a period of three months.

Locations

Country Name City State
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma

Sponsors (2)

Lead Sponsor Collaborator
University of Oklahoma United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported nutrition practices Providers report the frequency and type of fruit and vegetables, milk, and salty snacks served using the NAPSACC Self-Report tool virtually/on-paper, tailored for FCCH baseline, changes post 3-months, changes post 12-months
Primary nutrition environment Self-reporting the EPAO survey virtually/on-paper baseline, changes post 3-months, changes post 12-months
Primary compliance of menu and meal with Child and Adult Care Food Program requirements using compliance scoring tool created by collaborative research team menus and meals served are compared to the requirements and best practices of the CACFP using compliance scoring tool created by the collaborative research team baseline, changes post 3-months, changes post 12-months
Primary dietary quality of foods served analysis of remote food photograph of a child's breakfast, lunch, snack baseline, changes post 3-months, changes post 12-months
Secondary Provider self-efficacy providers will self report nutrition and environmental health self-efficacy using using survey created by the collaborative research team virtually/on-paper baseline, post 3-months, post 12-months
Secondary Environmental health observation observation of household cleaners and chemicals and signs of pests virtually, a tool created by the collaborative research team baseline, post 3-months, post 12-months
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