FRESH-EATS Project

NCT ID: NCT07053644

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-19

Study Completion Date

2026-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dietary Behaviors Obesity and Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Research assistants who collect outcome data are blinded from the study condition. Study participants are also masked regarding their intervention condition when they participate in baseline data collection while they would naturally identify which condition they are in at the post-intervention assessment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

FRESH-EATS

Intervention Type BEHAVIORAL

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.

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).

Group Type ACTIVE_COMPARATOR

Lagged Intervention Control Group

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Heewon Gray

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Heewon L. Gray, PhD, RDN

Role: CONTACT

+1 8139749881

Marilyn Stern, PhD

Role: CONTACT

+1 8139740966

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Heewon L Gray, PhD, RDN

Role: primary

+1 8139749881

References

Explore related publications, articles, or registry entries linked to this study.

Gray HL, Berumen JH, Lovett SM, Himmelgreen D, Biswas D, Bohn J, Peacock C, Buro AW. A Mixed-methods Study to Understand Food Environments and Grocery Shopping Patterns of Community Residents in Underserved Neighborhoods in Tampa, Florida. Ecol Food Nutr. 2021 Jul-Aug;60(4):435-453. doi: 10.1080/03670244.2020.1862098. Epub 2020 Dec 23.

Reference Type BACKGROUND
PMID: 33356564 (View on PubMed)

Hernandez DC, Reesor LM, Murillo R. Food insecurity and adult overweight/obesity: Gender and race/ethnic disparities. Appetite. 2017 Oct 1;117:373-378. doi: 10.1016/j.appet.2017.07.010. Epub 2017 Jul 22.

Reference Type BACKGROUND
PMID: 28739148 (View on PubMed)

Reedy J, Krebs-Smith SM. Dietary sources of energy, solid fats, and added sugars among children and adolescents in the United States. J Am Diet Assoc. 2010 Oct;110(10):1477-84. doi: 10.1016/j.jada.2010.07.010.

Reference Type BACKGROUND
PMID: 20869486 (View on PubMed)

Ghosh-Dastidar M, Hunter G, Collins RL, Zenk SN, Cummins S, Beckman R, Nugroho AK, Sloan JC, Wagner L, Dubowitz T. Does opening a supermarket in a food desert change the food environment? Health Place. 2017 Jul;46:249-256. doi: 10.1016/j.healthplace.2017.06.002. Epub 2017 Jun 22.

Reference Type BACKGROUND
PMID: 28648926 (View on PubMed)

Chen D, Jaenicke EC, Volpe RJ. Food Environments and Obesity: Household Diet Expenditure Versus Food Deserts. Am J Public Health. 2016 May;106(5):881-8. doi: 10.2105/AJPH.2016.303048. Epub 2016 Mar 17.

Reference Type BACKGROUND
PMID: 26985622 (View on PubMed)

Brown AG, Hudson LB, Chui K, Metayer N, Lebron-Torres N, Seguin RA, Folta SC. Improving heart health among Black/African American women using civic engagement: a pilot study. BMC Public Health. 2017 Jan 24;17(1):112. doi: 10.1186/s12889-016-3964-2.

Reference Type BACKGROUND
PMID: 28118823 (View on PubMed)

Sankofa J, Johnson-Taylor WL. News coverage of diet-related health disparities experienced by black Americans: a steady diet of misinformation. J Nutr Educ Behav. 2007 Mar-Apr;39(2 Suppl):S41-4. doi: 10.1016/j.jneb.2006.08.014.

Reference Type BACKGROUND
PMID: 17336804 (View on PubMed)

Larson NI, Story MT, Nelson MC. Neighborhood environments: disparities in access to healthy foods in the U.S. Am J Prev Med. 2009 Jan;36(1):74-81. doi: 10.1016/j.amepre.2008.09.025. Epub 2008 Nov 1.

Reference Type BACKGROUND
PMID: 18977112 (View on PubMed)

Zenk SN, Odoms-Young AM, Dallas C, Hardy E, Watkins A, Hoskins-Wroten J, Holland L. "You have to hunt for the fruits, the vegetables": environmental barriers and adaptive strategies to acquire food in a low-income African American neighborhood. Health Educ Behav. 2011 Jun;38(3):282-92. doi: 10.1177/1090198110372877. Epub 2011 Apr 21.

Reference Type BACKGROUND
PMID: 21511955 (View on PubMed)

Cubbin C, Hadden WC, Winkleby MA. Neighborhood context and cardiovascular disease risk factors: the contribution of material deprivation. Ethn Dis. 2001 Fall;11(4):687-700.

Reference Type BACKGROUND
PMID: 11763293 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R21MD019963

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY007833

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Time to Eat Study - Pilot
NCT03590847 COMPLETED NA
Healthier At-home Meals for Expectant Mothers
NCT05605340 ACTIVE_NOT_RECRUITING NA
Food Insecurity, Social Determinants of Health
NCT06784310 ACTIVE_NOT_RECRUITING NA