- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04345874
Virtual Technical Assistance for Child and Adult Care Food Program in Family Child Care Home
Compliance and Technical Assistance for Child and Adult Care Food Program in Family Child Care Homes- Virtual Implementation
Study Overview
Status
Conditions
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73114
- University of Oklahoma Health Sciences Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Nutrition technical assistance
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.
|
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.
|
EXPERIMENTAL: Children's environmental health technical assistance
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported nutrition practices
Time Frame: baseline, changes post 3-months, changes post 12-months
|
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
Time Frame: baseline, changes post 3-months, changes post 12-months
|
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
Time Frame: baseline, changes post 3-months, changes post 12-months
|
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
Time Frame: baseline, changes post 3-months, changes post 12-months
|
analysis of remote food photograph of a child's breakfast, lunch, snack
|
baseline, changes post 3-months, changes post 12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider self-efficacy
Time Frame: baseline, post 3-months, post 12-months
|
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
|
Environmental health observation
Time Frame: baseline, post 3-months, post 12-months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10747
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Health Behavior
-
Holbaek SygehusRecruitingHealth Behavior | Health Knowledge, Attitudes, Practice | Health-Related Behavior | Health LiteracyDenmark
-
Finnish Institute for Health and WelfareCompletedHealth Behavior | Health Care Utilization | Health Care Seeking BehaviorFinland
-
Basque Health ServiceUnknownHealth Promotion | Health Behavior | Health Education | Patient Education | Counseling | Behavior TherapySpain
-
University Hospital, Basel, SwitzerlandSolidarMed LesothoRecruitingRecruitment | Health Behavior | Motivation | Social Behavior | Health Care Utilization | Consumer Behavior | Health Care Seeking Behavior | Researcher-Subject RelationsLesotho
-
Imperial College LondonRecruitingHealth Attitude | Disease | Cancer | Health Behavior | Health Knowledge, Attitudes, Practice | Health-Related BehaviorUnited Kingdom
-
Research on Healthcare Performance Lab U1290RecruitingStress | Health Behavior | Health-Related BehaviorFrance
-
Azienda Sanitaria Locale CN2 Alba-BraUniversity of Turin, Italy; University of Eastern Piedmont; Eclectica Sas di...CompletedEffectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2) (DDS-2)Mental Health Wellness 1 | Health Behavior | Adolescent BehaviorItaly
-
Research on Healthcare Performance Lab U1290RecruitingSedentary Behavior | Sedentary Time | Health Behavior | Health-Related Behavior | Physical InactivityFrance
-
World Health OrganizationLondon School of Hygiene and Tropical Medicine; University of Ghana; Biomedical... and other collaboratorsRecruitingHealth-Related Behavior | Adolescent Behavior | Adolescent Development | Health Care Seeking BehaviorGhana, Tanzania, Zimbabwe
-
Ankara Yildirim Beyazıt UniversityNot yet recruitingHealth Attitude | Health Behavior | Health KnowledgeTurkey
Clinical Trials on Nutrition technical assistance
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH); Dartmouth-Hitchcock Medical Center and other collaboratorsActive, not recruitingObesity | Health Promotion | Mental Health Services | Organizational Innovation
-
Trustees of Dartmouth CollegeMayo Clinic; Georgetown UniversityRecruiting
-
Oregon Research InstituteStanford University; University of Texas at Austin; Trinity University, TexasCompletedEating DisorderUnited States
-
VA Office of Research and DevelopmentUS Department of Veterans Affairs Office of Mental Health and Suicide PreventionRecruiting
-
Duke UniversityUniversity of Pittsburgh; University of South Carolina; Whole Child InternationalCompletedMental Health Wellness 1 | Health Behavior | Child RearingEl Salvador
-
Mathematica Policy Research, Inc.Centers for Medicare and Medicaid ServicesCompletedMedicare Expenditures, Quality of CareUnited States
-
University of Rochester NCORP Research BaseNational Cancer Institute (NCI); University of Alabama at BirminghamEnrolling by invitationAdvanced Solid TumorUnited States
-
Stanford UniversityRecruiting
-
NYU Langone HealthWithdrawnTobacco Use CessationVietnam
-
Louisiana State University Health Sciences Center...University of California, Los Angeles; University of Southern California; National...CompletedDepression | Quality of Life | Anxiety | Social Stress | DisasterUnited States