NCT04345874

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

2.1 years

First QC Date

April 6, 2020

Last Update Submit

December 17, 2024

Conditions

Keywords

early childhood educationfamily childcare homefood environment

Outcome Measures

Primary Outcomes (4)

  • 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

  • nutrition environment

    Self-reporting the EPAO survey virtually/on-paper

    baseline, changes post 3-months, changes post 12-months

  • 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

  • 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 Outcomes (2)

  • Provider self-efficacy

    baseline, post 3-months, post 12-months

  • Environmental health observation

    baseline, post 3-months, post 12-months

Study Arms (2)

Nutrition technical assistance

EXPERIMENTAL

three encounters with Intervention team over three months: two virtual 60-90 minutes visits one-on-one with the FCCH each scheduled at the convenience of the provider and a 3- hour virtual group class with other providers.

Behavioral: Nutrition technical assistance

Children's environmental health technical assistance

EXPERIMENTAL

three encounters with Intervention team over three months: two virtual 60-90 minutes visits one-on-one with the FCCH each scheduled at the convenience of the provider and a 3- hour virtual group class with other providers.

Behavioral: Children's environmental health technical assistance

Interventions

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.

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Family Child Care Home Providers who care for only infants and toddlers and not speak English.
  • Participant withdraws.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73114, United States

Location

MeSH Terms

Conditions

MalnutritionHealth Behavior

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBehavior

Study Officials

  • Susan B Sisson, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized trial where family child care home providers are randomized to either nutrition or environmental health technical assistance intervention. Interventions are matched for time and contact.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 15, 2020

Study Start

November 1, 2019

Primary Completion

December 7, 2021

Study Completion

December 7, 2021

Last Updated

December 18, 2024

Record last verified: 2024-12

Locations