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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05745376
Other study ID # IRB881-23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date May 2024

Study information

Verified date January 2024
Source Xavier University of Louisiana.
Contact Megan Knapp, PhD
Phone 2143645483
Email mknapp@xula.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 435
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Farm to ECE programming
Students and parents at this center will receive program elements described in arm descriptions.

Locations

Country Name City State
United States Xavier University Of Louisiana New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Xavier University of Louisiana.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Primary 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. 6 months
Primary 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. 6 months
Primary 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. 6 months
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