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?

This trial aims to determine if the new program, FRESH-EATS, can help kids and their families improve their eating habits. The program includes cooking lessons, workshops on accessing healthy food, garden activities, and grocery deliveries. Researchers seek to understand if families find this program easy to follow and if it effectively improves their eating habits. Families in low-income neighborhoods with children aged 8-12 who speak English and have not participated in a similar program recently may be a good fit. Participants will either join the full program or start with educational sessions and add other activities later. As an unphased trial, this study offers families a unique opportunity to explore innovative ways to enhance their eating habits.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on dietary and lifestyle changes, so it's unlikely that medication changes are required, but you should confirm with the trial organizers.

What prior data suggests that the FRESH-EATS intervention is safe for children and their parents/caregivers?

Research has shown that the FRESH-EATS program is safe, as it focuses on improving nutrition and lifestyle. It includes activities such as cooking classes and family workshops, which are generally safe and beneficial. Past studies have not directly linked FRESH-EATS to any side effects or problems. Since the program does not involve medication, the risk of serious side effects is likely low. Participants engage in healthy activities like learning about food and using community gardens. These activities are typically manageable and aim to enhance overall health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about FRESH-EATS because it offers a comprehensive, lifestyle-based approach to tackling childhood obesity, unlike most standard treatments that focus solely on diet or exercise. The FRESH-EATS program includes hands-on cooking lessons, family workshops to improve access to healthy foods, engaging garden activities, and a budget for grocery delivery. This multilevel, multicomponent method aims to create sustainable, healthy habits by involving the entire family and integrating community resources, potentially leading to more effective long-term weight management for children.

What evidence suggests that the FRESH-EATS intervention is effective for improving dietary behaviors in children and their parents?

Research has shown that programs encouraging kids to eat more fruit can help reduce obesity in children. Studies have found that schools participating in initiatives like the Fresh Fruit and Vegetable Program often have fewer overweight and obese students than those that do not. In this trial, the FRESH-EATS program, part of the intervention arm, expands on these ideas by providing cooking lessons, family workshops, and community events to make healthy foods more accessible. Participants in the control arm will initially receive a six-week education-only intervention before accessing the full FRESH-EATS components. Lifestyle changes involving both kids and their families are known to help manage weight effectively. Overall, combining education with practical support has shown promise in encouraging healthier eating habits among children. ^{2 6 7 8 9}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9857183/

The Effects of Food Environment on Obesity in Children Of the 725 students studied, 24.8% were overweight and 20.7% were obese. The results showed that there were significantly more food venders near ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743523003717

The estimated effect of increasing fruit interventions on ... This meta-analysis provided evidence that interventions aimed at increasing fruit consumption were effective at reducing obesity prevalence.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4683105/

Design of the FRESH Study: A Randomized Controlled ... The current paper describes the FRESH study which was designed to compare the effectiveness of parent-based therapy for pediatric obesity (PBT) to a parent and ...

4. jstor.org jstor.org/stable/44788088

The Effect of the Fresh Fruit and Vegetable Program on ... The results indicate that FFVP participating schools have lower overweight rates, obesity rates, and average BMI z-scores than the. "synthetic" schools without ...

5. publications.aap.org publications.aap.org/pediatrics/article/151/2/e2022060640/190443/Clinical-Practice-Guideline-for-the-Evaluation-and

Clinical Practice Guideline for the Evaluation and ... Children with overweight and obesity benefit from health behavior and lifestyle treatment, which is a child-focused, family-centered, ...

6. jandonline.org jandonline.org/article/S2212-2672(21)01465-9/fulltext

Prevention of Pediatric Overweight and Obesity: Position ... From 2017 to 2018, the rate of pediatric obesity in the United States was 19.3%. Rates were 13.4% among 2- to 5-year-olds, 20.3% among 6- to 11-year-olds, and ...

7. cdc.gov cdc.gov/obesity/family-action/index.html

Preventing Childhood Obesity: 6 Things Families Can Do Compared to children with healthy weight, children with obesity are at a higher risk for asthma, sleep apnea, bone and joint problems, type 2 ...

8. withpower.com withpower.com/trial/phase-dietary-behaviors-5-2025-10d3a

FRESH-EATS for Childhood Obesity (FRESH-EATS Trial) The FRESH-EATS medical study, being run by University of South Florida, is evaluating whether FRESH-EATS will have tolerable side effects & efficacy for ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11294797/

The prevalence and prevention strategies of pediatric obesity The National School Health Examination data showed that pediatric obesity gradually increase from 11.5% in 2014 to 15.1% in 2019, and after the ...