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NCT Number: NCT07053644

FRESH-EATS Project

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.

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Key information

Conditions

Dietary Behaviors Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity and Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33620, United States

Location status: Recruiting

Location contact

Heewon L Gray, PhD, RDN

CONTACT

[email protected]

+1 8139749881

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FRESH-EATS

Behavioral
  • Six weekly Cooking Matters® for Families sessions. Each session is designed to take 90 minutes including hands-on cooking or other activities.
  • Two 90-minute family workshop sessions will be implemented.
  • 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.
  • 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 Group

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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).

  2. 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)

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Heewon L. Gray, PhD, RDN

CONTACT

[email protected]

+1 8139749881

Marilyn Stern, PhD

CONTACT

[email protected]

+1 8139740966

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Acronym: FRESH-EATS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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