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Dietary BehaviorsFRESH-EATSNCT07053644

FRESH-EATS Project

A study testing FRESH-EATS in people with Dietary Behaviors and Obesity and Overweight, run by University of South Florida at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dietary Behaviors, Obesity and Overweight
What is being tested?
FRESH-EATS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
19 Jun 2025to 31 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Heewon L. Gray, PhD, RDN contact

+1 8139749881

hlgray@usf.edu

Marilyn Stern, PhD contact

+1 8139740966

mstern1@usf.edu

United States1 site, 1 recruiting

  • University of South Florida

    Tampa, Florida, 33620

    Heewon L Gray, PhD, RDN, +1 8139749881, hlgray@usf.edu

    Recruiting

Other trials in United States

About this study

Official title: 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?

Read more

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.
Read the 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.

Being tested
FRESH-EATS, Lagged Intervention Control Group
Keywords
food insecurity, community-based, obesity prevention, nutrition education, behavioral intervention
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FRESH-EATSBehavioural

    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.

  • Lagged Intervention Control GroupBehavioural

    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.

Study groups in NCT07053644
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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
Receives: Behavioral: FRESH-EATS
ControlActive comparatorParticipants 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).
Receives: Behavioral: Lagged Intervention Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parent dietary behaviors

    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.

    Measured: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

  2. Children's dietary behaviors

    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

    Measured: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

Secondary outcomes (7)

  1. Anthropometrics: height, weight, waist/hip circumferences

    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).

    Measured: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

  2. Social Connectedness Scale

    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)

    Measured: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

  3. Resilience

    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.

    Measured: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

  4. Childhood Experiences Survey

    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

    Measured: At baseline (T1)

  5. Philadelphia Community- Level Adversity scale

    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.

    Measured: At baseline (T1)

  6. Perceived Food Access

    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.

    Measured: At baseline (T1)

  7. Blood Pressure

    Parents/caregivers' and children's blood pressure will be measured with a digital monitor (CONTEC 08A) by trained RAs.

    Measured: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2025
  2. Study start19 Jun 2025
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07053644
Sponsor's protocol ID
STUDY007833
Other IDs
R21MD019963
Acronym
FRESH-EATS
Status last verified
Jun 2025
First submitted
27 Jun 2025
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33356564

  • 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.

    PubMed 28739148

  • 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.

    PubMed 20869486

  • 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.

    PubMed 28648926

  • 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.

    PubMed 26985622

  • 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.

    PubMed 28118823

  • 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.

    PubMed 17336804

  • 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.

    PubMed 18977112

  • 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.

    PubMed 21511955

  • 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.

    PubMed 11763293

Questions about this trial

What is this clinical trial studying?

A study testing FRESH-EATS in people with Dietary Behaviors and Obesity and Overweight, run by University of South Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heewon L. Gray, PhD, RDN (+1 8139749881, hlgray@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parent dietary behaviors (time frame: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07053644, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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