Nutrition PoorNCT04345874
Virtual Technical Assistance for Child and Adult Care Food Program in Family Child Care Home
A study testing Nutrition technical assistance and Children's environmental health technical assistance in people with Nutrition Poor and Health Behavior, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Poor, Health Behavior
- What is being tested?
- Nutrition technical assistance and Children's environmental health technical assistance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 7 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Family Child Care Home Providers who care for only infants and toddlers and not speak English.
- Participant withdraws.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73114
About this study
Official title: Compliance and Technical Assistance for Child and Adult Care Food Program in Family Child Care Homes- Virtual Implementation
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.
Read the 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.
- Conditions
- Nutrition Poor, Health Behavior
- Being tested
- Nutrition technical assistance, Children's environmental health technical assistance
- Keywords
- early childhood education, family childcare home, food environment
- Medical subject headings
- Malnutrition, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition technical assistanceBehavioural
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 assistanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Children's environmental health technical assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, changes post 3-months, changes post 12-months
nutrition environment
Self-reporting the EPAO survey virtually/on-paper
Measured: 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
Measured: 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
Measured: baseline, changes post 3-months, changes post 12-months
Secondary outcomes (2)
Provider self-efficacy
providers will self report nutrition and environmental health self-efficacy using using survey created by the collaborative research team virtually/on-paper
Measured: baseline, post 3-months, post 12-months
Environmental health observation
observation of household cleaners and chemicals and signs of pests virtually, a tool created by the collaborative research team
Measured: baseline, post 3-months, post 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Nov 2019
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition PoorStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
- Investigators
- Susan B Sisson, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345874
- Sponsor's protocol ID
- 10747
- Status last verified
- Dec 2024
- First submitted
- 6 Apr 2020
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance and Technical Assistance for Child and Adult Care Food Program in Family Child Care Homes- Virtual Implementation
- ClinicalTrials.gov ID
- NCT04345874
- Acronym / sponsor ID
- 10747
- Conditions
- Nutrition Poor, Health Behavior
- Keywords
- early childhood education, family childcare home, food environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nutrition technical assistance | Experimental | Behavioral: Nutrition technical assistancethree 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. |
| Children's environmental health technical assistance | Experimental | Behavioral: Children's environmental health technical assistancethree 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Family Child Care Home Providers who care for only infants and toddlers and not speak English.
- Participant withdraws.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition technical assistanceParticipating 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. | Behavioural | Nutrition technical assistance |
| Children's environmental health technical assistanceParticipating 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. | Behavioural | Children's environmental health technical assistance |
Primary outcome
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
nutrition environment
Time frame: baseline, changes post 3-months, changes post 12-months
Self-reporting the EPAO survey virtually/on-paper
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
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
2 secondary outcomes
Provider self-efficacy
Time frame: baseline, post 3-months, post 12-months
Environmental health observation
Time frame: baseline, post 3-months, post 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
Related trials for Nutrition Poor
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan B Sisson, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition technical assistance and Children's environmental health technical assistance in people with Nutrition Poor and Health Behavior, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported nutrition practices (time frame: baseline, changes post 3-months, changes post 12-months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.