NCT03560050

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

May 28, 2026

Completed
Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 23, 2018

Results QC Date

December 17, 2024

Last Update Submit

May 1, 2026

Conditions

Nutrition PoorHealth Behavior

Keywords

early childhood educationfamily child care homefood environment

Outcome Measures

Primary Outcomes (1)

  • Change in Self-reported Nutrition Practices

    Providers report the nutrition environment using the Nutrition and Physical Activity Self Assessment for Child Care (NAPSACC). Scores averaged across items range 0-4. Higher score indicates more desired/healthier outcome.

    baseline, post 3-months, post 12-months

Secondary Outcomes (3)

  • Provider Nutrition Knowledge

    baseline, post 3-months, post 12-months

  • Change in Compliance of Menu With Child and Adult Care Food Program Best Practices

    baseline, post 3-months, post 12-months

  • Change in Children's Dietary Intake of Vegetables at Lunch

    baseline, post 3-months, post 12-months

Study Arms (2)

Behavioral: Nutrition assistance

EXPERIMENTAL

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

Behavioral: Children's environmental health

EXPERIMENTAL

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/comparison

Interventions

Nutrition assistanceBEHAVIORAL

Participating family child care home providers in and around the Oklahoma City (OKC) area will be randomized to either the Nutrition, or an environmental health comparison group. 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.

Behavioral: Nutrition assistance
Children's environmental health/comparisonBEHAVIORAL

Participating family child care home providers in and around the OKC area will be randomized to either the Nutrition, or an environmental health intervention 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.

Behavioral: Children's environmental health

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 within 60 minutes of Oklahoma City who participate in the Child and Adults Care Food Program

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

Related Publications (3)

  • Sisson SB, Leidner J, Hall S, Williams BD, Vesely SK, Poe T, Ward DS, Crosscut C, Hildebrand D, Salvatore AL. Three- and Twelve-Month Changes in Child and Adult Care Food Program Best Practices and Preschool Children's Dietary Intake in Family Child Care Homes after the Happy Healthy Homes Randomized Controlled Trial. Child Obes. 2025 Jul;21(5):476-488. doi: 10.1089/chi.2024.0361. Epub 2025 Mar 10.

    PMID: 40059639DERIVED

  • 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 Aug;25(8):2111-2124. doi: 10.1017/S1368980022000337. Epub 2022 Feb 7.

    PMID: 35125128DERIVED

  • 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.

    PMID: 31470886DERIVED

MeSH Terms

Conditions

MalnutritionHealth Behavior

Interventions

Food Assistance

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Public AssistanceFinancing, GovernmentFinancing, OrganizedEconomicsHealth Care Economics and Organizations

Results Point of Contact

Title
Dr. Susan B. Sisson, Principal Investigator
Organization
University of Oklahoma Health Sciences
susan-sisson@ouhsc.edu
(405) 271-2113

Study Officials

  • Susan B Sisson, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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 (the participant) 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

May 23, 2018

First Posted

June 18, 2018

Study Start

October 1, 2017

Primary Completion

March 30, 2019

Study Completion

October 30, 2019

Last Updated

May 28, 2026

Results First Posted

May 28, 2026

Record last verified: 2026-05

Locations

US(1)