FRESH-EATS Project

NCT07053644 | Recruiting

• 2 other identifiers: STUDY007833R21MD019963
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Parent dietary behaviors

  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.

  At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

• Children's dietary behaviors

  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

  At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

Secondary Outcomes (7)

• Anthropometrics: height, weight, waist/hip circumferences

  At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

• Social Connectedness Scale

  At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

• Resilience

  At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.

• Childhood Experiences Survey

  At baseline (T1)

• Philadelphia Community- Level Adversity scale

  At baseline (T1)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: FRESH-EATS

Control

ACTIVE COMPARATOR

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).

Behavioral: Lagged Intervention Control Group

Interventions

FRESH-EATS BEHAVIORAL

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.

Intervention

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English Speaking
• Parents/caregivers that are 18 years or older
• Residents of targeted neighborhood
• Have a child aged 8-12 years old

You may not qualify if:

• Parents/caregivers or children who have participated in a similar intervention within the past 6 months
• Do not speak English

Sponsors & Collaborators

• University of South Florida: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

RECRUITING

Related Publications (10)

• Gray HL, Berumen JH, Lovett SM, Himmelgreen D, Biswas D, Bohn J, Peacock C, Buro AW. A Mixed-methods Study to Understand Food Environments and Grocery Shopping Patterns of Community Residents in Underserved Neighborhoods in Tampa, Florida. Ecol Food Nutr. 2021 Jul-Aug;60(4):435-453. doi: 10.1080/03670244.2020.1862098. Epub 2020 Dec 23.

  PMID: 33356564 BACKGROUND

• Hernandez DC, Reesor LM, Murillo R. Food insecurity and adult overweight/obesity: Gender and race/ethnic disparities. Appetite. 2017 Oct 1;117:373-378. doi: 10.1016/j.appet.2017.07.010. Epub 2017 Jul 22.

  PMID: 28739148 BACKGROUND

• Reedy J, Krebs-Smith SM. Dietary sources of energy, solid fats, and added sugars among children and adolescents in the United States. J Am Diet Assoc. 2010 Oct;110(10):1477-84. doi: 10.1016/j.jada.2010.07.010.

  PMID: 20869486 BACKGROUND

• Ghosh-Dastidar M, Hunter G, Collins RL, Zenk SN, Cummins S, Beckman R, Nugroho AK, Sloan JC, Wagner L, Dubowitz T. Does opening a supermarket in a food desert change the food environment? Health Place. 2017 Jul;46:249-256. doi: 10.1016/j.healthplace.2017.06.002. Epub 2017 Jun 22.

  PMID: 28648926 BACKGROUND

• Chen D, Jaenicke EC, Volpe RJ. Food Environments and Obesity: Household Diet Expenditure Versus Food Deserts. Am J Public Health. 2016 May;106(5):881-8. doi: 10.2105/AJPH.2016.303048. Epub 2016 Mar 17.

  PMID: 26985622 BACKGROUND

• Brown AG, Hudson LB, Chui K, Metayer N, Lebron-Torres N, Seguin RA, Folta SC. Improving heart health among Black/African American women using civic engagement: a pilot study. BMC Public Health. 2017 Jan 24;17(1):112. doi: 10.1186/s12889-016-3964-2.

  PMID: 28118823 BACKGROUND

• Sankofa J, Johnson-Taylor WL. News coverage of diet-related health disparities experienced by black Americans: a steady diet of misinformation. J Nutr Educ Behav. 2007 Mar-Apr;39(2 Suppl):S41-4. doi: 10.1016/j.jneb.2006.08.014.

  PMID: 17336804 BACKGROUND

• Larson NI, Story MT, Nelson MC. Neighborhood environments: disparities in access to healthy foods in the U.S. Am J Prev Med. 2009 Jan;36(1):74-81. doi: 10.1016/j.amepre.2008.09.025. Epub 2008 Nov 1.

  PMID: 18977112 BACKGROUND

• Zenk SN, Odoms-Young AM, Dallas C, Hardy E, Watkins A, Hoskins-Wroten J, Holland L. "You have to hunt for the fruits, the vegetables": environmental barriers and adaptive strategies to acquire food in a low-income African American neighborhood. Health Educ Behav. 2011 Jun;38(3):282-92. doi: 10.1177/1090198110372877. Epub 2011 Apr 21.

  PMID: 21511955 BACKGROUND

• Cubbin C, Hadden WC, Winkleby MA. Neighborhood context and cardiovascular disease risk factors: the contribution of material deprivation. Ethn Dis. 2001 Fall;11(4):687-700.

  PMID: 11763293 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Heewon L. Gray, PhD, RDN

CONTACT

+1 8139749881; hlgray@usf.edu

Marilyn Stern, PhD

CONTACT

+1 8139740966; mstern1@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Research assistants who collect outcome data are blinded from the study condition. Study participants are also masked regarding their intervention condition when they participate in baseline data collection while they would naturally identify which condition they are in at the post-intervention assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: June 19, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

US (1)