FRESH-EATS Project (FRESH-EATS)

June 27, 2025 updated by: Heewon Gray, University of South Florida

Community-derived Multilevel-Multicomponent Nutrition Intervention to Reduce Food Access Disparities -FRESH-EATS

The goal of this randomized controlled trial is to determine the feasibility of the FRESH-EATS project in children ages 8-12 and their parents/caregivers residing in low-income, predominantly minority neighborhoods. The main questions it aims to answer are:

Is the FRESH-EATS intervention feasible to implement and well-received by parent-child dyads? Does the FRESH-EATS multilevel multicomponent intervention improve dietary behaviors of children and their parents/caregivers compared to the comparison group?

We hypothesize that this innovative community-derived, multilevel-multicomponent intervention is feasible to implement and has the potential to improve dietary behaviors of participants (children ages 8-12 and their parents/caregivers).

Researchers will compare the FRESH-EATS intervention group to the Lagged Intervention Control Group (LICG) to see if the FRESH-EATS intervention leads to better dietary behaviors and health outcomes.

Participants in the FRESH-EATS intervention group will:

  • Attend educational sessions on healthy eating and cooking.
  • Participate in family workshops that address access to healthy food.
  • Receive food deliveries and information about local food resources.
  • Engage in community garden activities.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The FRESH-EATS project is a comprehensive intervention designed to address food access disparities and improve dietary behaviors among families in low-income neighborhoods. The intervention includes four key components. This program is tailored for school-aged children (ages 8-12) and their parents/caregivers, focusing on healthy eating as a family. Eight cohorts, each consisting of 6 families (48 families in total), will be recruited. Four cohorts (24 families) will participate in the FRESH-EATS intervention, while the other four cohorts (24 families) will be randomly assigned to the Lagged Intervention Control (LICG). The randomized controlled trial (RCT) design will compare the outcomes of the FRESH-EATS intervention group to the LICG group, with outcome evaluations conducted at both pre- and post-intervention stages.

First, it features evidence-based hands-on cooking and nutrition education using the Cooking Matters® for Families program. Additionally, the project includes family workshops aimed at addressing the lack of access to healthy foods and systemic disparities in the food environment. Throughout the intervention period, participants in the intervention group will receive food deliveries and information about local food resources such as food pantries. An updated list of local food pantries will be obtained from the local food bank. Handouts featuring different food pantries will be created and distributed to families. Intervention participants will receive community garden education that will provide fresh ingredients for participants to use during cooking lessons. The lead community organization has a community garden with 12 garden beds, which is active year-round in Florida. Season-specific garden education and activities will be integrated into the nutrition lessons, further supporting the project's goals of improving dietary behaviors and addressing food access disparities.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Heewon L. Gray, PhD, RDN
  • Phone Number: +1 8139749881
  • Email: hlgray@usf.edu

Study Contact Backup

  • Name: Marilyn Stern, PhD
  • Phone Number: +1 8139740966
  • Email: mstern1@usf.edu

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University of South Florida
        • Contact:
          • Heewon L Gray, PhD, RDN
          • Phone Number: +1 8139749881
          • Email: hlgray@usf.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • English Speaking
  • Parents/caregivers that are 18 years or older
  • Residents of targeted neighborhood
  • Have a child aged 8-12 years old

Exclusion Criteria:

  • Parents/caregivers or children who have participated in a similar intervention within the past 6 months
  • Do not speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants will receive multilevel multicomponent intervention FRESH-EATS. Four components include (1) Cooking lessons; (2) Family workshops addressing access to food; (3) Garden activities/education; and (4) Grocery delivery budget
Behavioral: FRESH-EATS
  1. Six weekly Cooking Matters® for Families sessions. Each session is designed to take 90 minutes including hands-on cooking or other activities.
  2. Two 90-minute family workshop sessions will be implemented.
  3. Food delivery budget (i.e., the Walmart+ annual membership with free shipping and gift cards to purchase ingredients) will be provided up during the intervention period and local food pantry information will be distributed to families.
  4. Community garden at the Cornerstone Family Ministries will be utilized by incorporating garden activities, harvesting, and cooking with the produce from the garden.
Active Comparator: Control
Participants in the active comparison group will receive a six week education-only control intervention. After completing the post-intervention assessments, these families will receive the other components (family workshops, food delivery budget, and community garden involvement).
Behavioral: Lagged Intervention Control Group
Nutrition education materials that address nutrition in school-age children and families Cooking Matters® for Families will be implemented. Each of six sessions will take about 90 minutes. All lessons will be delivered by qualified nutrition educators along with student assistants at the Cornerstone Family Ministries classrooms. After completing the post-intervention assessment, participants will then receive the other FRESH-EATS intervention components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent dietary behaviors
Time Frame: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.
The Cooking Matters for Families Survey consists of 39 item, including questions on participants' dietary habits, meal preparation practices, food security, and attitudes towards healthy eating.
At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.
Children's dietary behaviors
Time Frame: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.
Consists of 31 items. It assesses dietary intake of children including fruits, vegetables, beverages, and snack foods. The questionnaire is used to measure changes in these areas before and after an intervention
At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometrics: height, weight, waist/hip circumferences
Time Frame: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.
Assess children's height and weight with a professional stadiometer (SECA 213) and a weight scale (Tanita WB-800S) following the standardized protocol used in previous studies. As a standard weight status assessment for children, BMI percentile and z-scores based on the CDC growth chart will be calculated. Parent/caregiver BMI (kg/m²) will be calculated from waist and hip circumferences measurements collected by trained RAs using a circumference measuring tape (SECA 203).
At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.
Social Connectedness Scale
Time Frame: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.
Scale consists of 20 items. It measures the extent to which individuals feel connected to others in their social environment, assessing dimensions such as belongingness, closeness, support, and satisfaction with social relationships. Each item is rated on a 6-point Likert scale, ranging from 1 (strongly disagree) to 6 (strongly agree)
At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.
Resilience
Time Frame: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.
Connor-Davidson Resilience Scale consists of 10 items. It measures resilience, or the ability to cope with and bounce back from adversity. Each item is rated on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). The total score ranges from 0 to 40, with higher scores indicating greater resilience.
At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.
Childhood Experiences Survey
Time Frame: At baseline (T1)
An expanded and modified adverse childhood experiences assessment which consists of 17 questions including 10 conventional ACEs and 7 additional questions on financial problems, food insecurity, homelessness, death of a family member, prolonged parental absence, peer victimization, and violent crime victimization
At baseline (T1)
Philadelphia Community- Level Adversity scale
Time Frame: At baseline (T1)
This scale consists of 5 items. It measures community-level adversities such as witnessing violence, experiencing discrimination, living in an unsafe neighborhood, being bullied, and living in foster care. Each item is rated on a scale that reflects the frequency or intensity of these experience.
At baseline (T1)
Perceived Food Access
Time Frame: At baseline (T1)
Perceived food access data will be collected using six questions on perceptions of the food environment (e.g., how much of a problem would you say that lack of access to adequate food shopping is in your neighborhood?). The validity and reliability of these questions has been assessed in previous studies showing that the questions are valid and have good internal and test-retest reliability.
At baseline (T1)
Blood Pressure
Time Frame: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.
Parents/caregivers' and children's blood pressure will be measured with a digital monitor (CONTEC 08A) by trained RAs.
At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

June 27, 2025

First Submitted That Met QC Criteria

June 27, 2025

First Posted (Estimated)

July 8, 2025

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY007833
  • R21MD019963 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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