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Trial record 1 of 1 for:    NCT03560050
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Technical Assistance for Child and Adult Care Food Program in Family Child Care Home

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ClinicalTrials.gov Identifier: NCT03560050
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Susan B. Sisson, University of Oklahoma

Brief 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.

Condition or disease Intervention/treatment Phase
Nutrition Poor Health Behavior Behavioral: Nutrition assistance Behavioral: Children's environmental health Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Compliance and Technical Assistance for Child and Adult Care Food Program in Family Child Care Homes
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : March 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


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.
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.

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.
Behavioral: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Change in Environmental health observation [ Time Frame: baseline, post 3-months, post 12-months ]
    observation of household cleaners and chemicals and signs of pests

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560050


Contacts
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Contact: Susan B Sisson, PhD 405-271-2113 ext 41176 susan-sisson@ouhsc.edu
Contact: Alicia L Salvatore, DrPH alicia-salvatore@ouhsc.edu

Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Susan B Sisson, PhD    405-271-2113 ext 41176    susan-sisson@ouhsc.edu   
Contact: Alicia L. Salvatore, DrPH       alicia-salvatore@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Susan B Sisson, PhD University of Oklahoma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Susan B. Sisson, Associate Professor, University of Oklahoma
ClinicalTrials.gov Identifier: NCT03560050     History of Changes
Other Study ID Numbers: 7551
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susan B. Sisson, University of Oklahoma:
early childhood education
family child care home
food environment
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders