Food InsecurityFarmtoECENCT05745376
Addressing Disparities in Food Access Among Young Children in Louisiana: A Farm to ECE Approach
A study testing Farm to ECE programming in people with Food Insecurity and Health Knowledge, Attitudes, Practice, run by Xavier University of Louisiana. at 1 site in United States.
Trial summary
The goal of this pilot project is to increase access to healthy food, improve diets, and reduce food insecurity and, in turn, reduce health disparities among low-income, minority children under the age of five attending early childcare centers. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Health Knowledge, Attitudes, Practice, Nutrition, Healthy
- What is being tested?
- Farm to ECE programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Jul 2024
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent or guardian of current student at participating center
- 18 years of age minimum
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Xavier University Of Louisiana
New Orleans, Louisiana, 70125
About this study
The goal of this pilot project is to increase access to healthy food, improve diets, and reduce food insecurity and, in turn, reduce health disparities among low-income, minority children under the age of five attending early childcare centers. Specific aims are to: 1) examine the feasibility of a six-month Farm to ECE intervention and 2) collect preliminary data to evaluate the efficacy of the program to 2.1) improve the ECE nutrition environment from baseline to follow-up; 2.2) increase access to local fruits and vegetables among children at ECEs from baseline to follow-up; and 2.3) increase parent knowledge and use of community food resources. The investigators will use this preliminary data to develop a larger scale project to test intervention efficacy.
Read the detailed description
The pilot study will take place at four centers within a network of Catholic Charities Early Head Start and Head Start Centers in New Orleans, Louisiana. Two centers will serve as intervention sites and two as comparison sites. Over 90% of the network centers' students identify as Black, and all qualify for federally funded free meals and snacks. The intervention will include: (1) assisting ECEs with conducting self-assessments; (2) connecting ECEs with local farmers and food producers; (3) providing technical assistance for menu changes, procuring healthy food, identifying and implementing best feeding practices and policies for the environment; (4) delivering nutrition education; and (5) connecting parents/guardians with local food resources and affordable fresh food to be consumed at home. The intervention will be implemented for 6 months.
Aim 1 uses a cross-sectional mixed methods design, collecting both quantitative and qualitative data in intervention centers. Aim 2 uses a pre-post design with a comparison group, collecting quantitative survey data at the center and parent level. At baseline and six-month follow-up, the investigators will conduct short surveys with staff and parents/caregivers of children attending ECEs.
- Being tested
- Farm to ECE programming
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Farm to ECE programmingBehavioural
Students and parents at this center will receive program elements described in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Center | Experimental | The intervention will include: (1) assisting ECEs with conducting self-assessments; (2) connecting ECEs with local farmers and food producers; (3) providing technical assistance for menu changes, procuring healthy food, identifying and implementing best feeding practices and policies for the environment; (4) delivering nutrition education; and (5) connecting parents/guardians with local food resources and affordable fresh food to be consumed at home Receives: Behavioral: Farm to ECE programming |
| Comparison | No intervention | No programming at center, only surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of parent/guardian use of community food resources
Parent/guardian surveys will ask questions about use of community food resources. Frequencies will be calculated based on results.
Measured: 6 months
nutrition environment score measured by NAPSACC
Environmental assessments and pre/post staff surveys using validated tools (Nutrition and Physical Activity Self-Assessment for Child Care NAPSACC) will be used to determine changes in the nutrition environment and healthy options. Nutrition environment scores will be calculated using the tool scoring guide.
Measured: 6 months
percent completion of program components (fidelity)
Staff will be asked to complete tracking records of all executed program components. Percent completion will be calculated by dividing program components executed by total program components.
Measured: 6 months
satisfaction score with program implementation
Staff will be asked to complete a post intervention survey to indicate their satisfaction (scale of 1-5) with the program implementation and its components.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Sep 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- intervention and comparison
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xavier University of Louisiana.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Knapp, PhD, Principal investigator, Xavier University of Louisiana.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745376
- Sponsor's protocol ID
- IRB881-23
- Acronym
- FarmtoECE
- Status last verified
- Aug 2024
- First submitted
- 6 Feb 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Disparities in Food Access Among Young Children in Louisiana: A Farm to ECE Approach
- ClinicalTrials.gov ID
- NCT05745376
- Acronym / sponsor ID
- FarmtoECE / IRB881-23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Xavier University of Louisiana.University, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 27 Feb 2023 (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.
The goal of this pilot project is to increase access to healthy food, improve diets, and reduce food insecurity and, in turn, reduce health disparities among low-income, minority children under the age of five attending early childcare centers. Specific aims are to: 1) examine the feasibility of a six-month Farm to ECE intervention and 2) collect preliminary data to evaluate the efficacy of the program to 2.1) improve the ECE nutrition environment from baseline to follow-up; 2.2) increase access to local fruits and vegetables among children at ECEs from baseline to follow-up; and 2.3) increase parent knowledge and use of community food resources. The investigators will use this preliminary data to develop a larger scale project to test intervention efficacy.
Detailed description
The pilot study will take place at four centers within a network of Catholic Charities Early Head Start and Head Start Centers in New Orleans, Louisiana. Two centers will serve as intervention sites and two as comparison sites. Over 90% of the network centers' students identify as Black, and all qualify for federally funded free meals and snacks. The intervention will include: (1) assisting ECEs with conducting self-assessments; (2) connecting ECEs with local farmers and food producers; (3) providing technical assistance for menu changes, procuring healthy food, identifying and implementing best feeding practices and policies for the environment; (4) delivering nutrition education; and (5) connecting parents/guardians with local food resources and affordable fresh food to be consumed at home. The intervention will be implemented for 6 months.
Aim 1 uses a cross-sectional mixed methods design, collecting both quantitative and qualitative data in intervention centers. Aim 2 uses a pre-post design with a comparison group, collecting quantitative survey data at the center and parent level. At baseline and six-month follow-up, the investigators will conduct short surveys with staff and parents/caregivers of children attending ECEs.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention and comparison
| Arm | Type | Receives |
|---|---|---|
| Intervention Center | Experimental | Behavioral: Farm to ECE programmingThe intervention will include: (1) assisting ECEs with conducting self-assessments; (2) connecting ECEs with local farmers and food producers; (3) providing technical assistance for menu changes, procuring healthy food, identifying and implementing best feeding practices and policies for the environment; (4) delivering nutrition education; and (5) connecting parents/guardians with local food resources and affordable fresh food to be consumed at home |
| Comparison | No intervention | –No programming at center, only surveys |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parent or guardian of current student at participating center
- 18 years of age minimum
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Farm to ECE programmingStudents and parents at this center will receive program elements described in arm descriptions. | Behavioural | Intervention Center |
Primary outcome
incidence of parent/guardian use of community food resources
Time frame: 6 months
Parent/guardian surveys will ask questions about use of community food resources. Frequencies will be calculated based on results.
nutrition environment score measured by NAPSACC
Time frame: 6 months
Environmental assessments and pre/post staff surveys using validated tools (Nutrition and Physical Activity Self-Assessment for Child Care NAPSACC) will be used to determine changes in the nutrition environment and healthy options. Nutrition environment scores will be calculated using the tool scoring guide.
percent completion of program components (fidelity)
Time frame: 6 months
Staff will be asked to complete tracking records of all executed program components. Percent completion will be calculated by dividing program components executed by total program components.
satisfaction score with program implementation
Time frame: 6 months
Staff will be asked to complete a post intervention survey to indicate their satisfaction (scale of 1-5) with the program implementation and its components.
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 14 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Megan Knapp, PhD principal investigator
Xavier University of Louisiana.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Farm to ECE programming in people with Food Insecurity and Health Knowledge, Attitudes, Practice, run by Xavier University of Louisiana. 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 2 inclusion and 1 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 14 Aug 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?
incidence of parent/guardian use of community food resources (time frame: 6 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 14 Aug 2024.