NCT05745376

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

February 6, 2023

Last Update Submit

August 12, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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

Behavioral: Farm to ECE programming

Comparison

NO INTERVENTION

No programming at center, only surveys

Interventions

Students and parents at this center will receive program elements described in arm descriptions.

Intervention Center

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Director or staff of participating center
  • years of age minimum

You may not qualify if:

  • Staff not involved with educational programming
  • Parent or guardian of current student at participating center
  • years of age minimum
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xavier University Of Louisiana

New Orleans, Louisiana, 70125, United States

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Megan Knapp, PhD

    Xavier University of Louisiana.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: intervention and comparison
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 27, 2023

Study Start

September 1, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations