- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05745376
Addressing Disparities in Food Access Among Young Children in Louisiana: A Farm to ECE Approach (FarmtoECE)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70125
- Xavier University of Louisiana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria (Key informant interviews and center assessments):
- Director or staff of participating center
- 18 years of age minimum
Exclusion Criteria (Key informant interviews and center assessments):
• Staff not involved with educational programming
Inclusion Criteria (Parent/guardian surveys):
- Parent or guardian of current student at participating center
- 18 years of age minimum
Exclusion Criteria (Parent/guardian surveys):
• None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Center
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
|
Students and parents at this center will receive program elements described in arm descriptions.
|
|
No Intervention: Comparison
No programming at center, only surveys
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
|
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.
|
6 months
|
|
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.
|
6 months
|
|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Megan Knapp, PhD, Xavier University of Louisiana.
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
Other Study ID Numbers
- IRB881-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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