FRESH-EATS for Childhood Obesity

(FRESH-EATS Trial)

Overseen By Marilyn Stern, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Similar intervention, Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

The FRESH-EATS Project is for children aged 8-12 and their parents/caregivers living in low-income, minority neighborhoods. It's designed to see if a new program can help them eat better. To join, families must be willing to attend educational sessions, workshops, receive food deliveries, and take part in community gardening.

Inclusion Criteria

English Speaking

Residents of targeted neighborhood

I am a parent or caregiver and I am 18 years old or older.

Exclusion Criteria

Parents/caregivers or children who have participated in a similar intervention within the past 6 months

I do not speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the FRESH-EATS multilevel multicomponent intervention, including cooking lessons, family workshops, garden activities, and grocery delivery budget

6-8 weeks

Weekly sessions

Control

Participants in the control group receive a six-week education-only intervention

6 weeks

Follow-up

Participants are monitored for changes in dietary behaviors and health outcomes post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FRESH-EATS
• Lagged Intervention Control Group

Trial Overview This study tests the FRESH-EATS intervention against a delayed control group to check if it improves eating habits and health outcomes. The intervention includes education on healthy eating, cooking workshops, access to fresh food resources like deliveries and community gardens.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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 II: Control Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+