FRESH-EATS Project
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Florida
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
English Speaking
Parents/caregivers that are 18 years or older
Residents of targeted neighborhood
Have a child aged 8-12 years old
Disqualifiers
Parents/caregivers or children who have participated in a similar intervention within the past 6 months
Do not speak English
Trial design
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.2
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
Time frame
At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.Secondary outcomes
1
Anthropometrics: height, weight, waist/hip circumferences
Assess children's height and weight with a professional stadiometer (SECA 213) and a weight scale (Tanita WB-800S) following the standardized protocol used in previous studies. As a standard weight status assessment for children, BMI percentile and z-scores based on the CDC growth chart will be calculated. Parent/caregiver BMI (kg/m²) will be calculated from waist and hip circumferences measurements collected by trained RAs using a circumference measuring tape (SECA 203).
Time frame
At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.2
Social Connectedness Scale
Scale consists of 20 items. It measures the extent to which individuals feel connected to others in their social environment, assessing dimensions such as belongingness, closeness, support, and satisfaction with social relationships. Each item is rated on a 6-point Likert scale, ranging from 1 (strongly disagree) to 6 (strongly agree)
Time frame
At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.3
Resilience
Connor-Davidson Resilience Scale consists of 10 items. It measures resilience, or the ability to cope with and bounce back from adversity. Each item is rated on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). The total score ranges from 0 to 40, with higher scores indicating greater resilience.
Time frame
At baseline (T1) and post-intervention (T2) approximately 6-8 weeks from baseline.4
Childhood Experiences Survey
An expanded and modified adverse childhood experiences assessment which consists of 17 questions including 10 conventional ACEs and 7 additional questions on financial problems, food insecurity, homelessness, death of a family member, prolonged parental absence, peer victimization, and violent crime victimization
Time frame
At baseline (T1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of South Florida
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov