Recruiting

FRESH-EATS

Sponsor:

University of South Florida

Code:

NCT07053644

Conditions

Dietary Behaviors

Obesity and Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

FRESH-EATS

Lagged Intervention Control Group

Study Details

Brief 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. 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.

Conditions

Dietary Behaviors

Obesity and Overweight

Study ID

NCT07053644

Start date

Jun 19, 2025

Status verified date

Jun, 2025

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: 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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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).

Interventions

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.

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.

Primary outcome measure

  • Parent dietary behaviors [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Heewon L. Gray, PhD, RDN

+1 8139749881hlgray@usf.edu

Marilyn Stern, PhD

+1 8139740966mstern1@usf.edu

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33620

Contacts

Heewon L Gray, PhD, RDN

+1 8139749881hlgray@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Jul 8, 2025

Last verified

Jun, 2025

Keywords

  • food insecurity
  • community-based
  • obesity prevention
  • nutrition education
  • behavioral intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2025-07-08.