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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03560050
Other study ID # 7551
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date October 30, 2019

Study information

Verified date March 2020
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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date October 30, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nutrition assistance
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.
Children's environmental health
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in self-reported nutrition practices Providers report the frequency of fruit and vegetables, milk, and salty snacks served baseline, post 3-months, post 12-months
Secondary Change in Provider knowledge and self efficacy providers will self report nutrition and environmental health knowledge and self efficacy baseline, post 3-months, post 12-months
Secondary Change in Environmental health observation observation of household cleaners and chemicals and signs of pests baseline, post 3-months, post 12-months
Secondary Change in nutrition environment using the Environment and Policy Assessment Observation observation of food environment during lunch on 2 unannounced days baseline, post 3-months, post 12-months
Secondary Change in compliance of menu and meal with Child and Adult Care Food Program menus and meals are compared to the requirements and best practices of the CACFP baseline, post 3-months, post 12-months
Secondary Change in children's dietary intake observation of children's dietary intake on 2 unannounced days baseline, post 3-months, post 12-months
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