FRESH-EATS Project
Part of paid clinical trials in Tampa, Florida.
- Sponsor
- University of South Florida
- Study ID
- NCT07053644
- Status
- Recruiting
Conditions
- Dietary Behaviors
- Obesity and Overweight
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- FRESH-EATS — BEHAVIORAL1. 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 — BEHAVIORALNutrition 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 Details
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.
Key Dates
- Start date
- Jun 19, 2025
- Status verified
- Jun 2025
- Primary completion
- Jul 31, 2026
- Completion
- Oct 31, 2026
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: InterventionParticipants 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: ControlParticipants 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).
Primary Outcome Measure
Parent dietary behaviors [ Time Frame: At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline. ]
Central Contacts
- Heewon L. Gray, PhD, RDN+1 8139749881
- Marilyn Stern, PhD+1 8139740966
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33620 |
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