EBT Fruit and Vegetable Prescription

NCT05028205 | Recruiting

• 1 other identifier: UTK IRB-21-06251-FB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Eating Better Together is a 6-month pilot program that teaches families about healthy eating and activity and provides home deliveries of fresh fruits and vegetables from a local retail partner.

Conditions

Childhood Obesity; Obesity

Keywords

Fruit and Vegetable Prescription; Food Security

Outcome Measures

Primary Outcomes (5)

• Project Reach, the number of participants who participate in the study

  Measurement in project reach will aid in the evaluation of the implementation process for the study, and will help us determine the feasibility of a larger study. Reach will be determined using the data from the EHR at CHS. Specifically, investigators will use data reports from the EHR to determine the number of participants who participate in the study.

  through study completion, an average of 6 months

• Project Reach, participants who are eligible to participate in this study, but decline to participate in the study

  Measurement in project reach will aid in the evaluation of the implementation process for the study, and will help us determine the feasibility of a larger study. Reach will be determined using the data from the EHR at CHS. Specifically, investigators will use data reports from the EHR to determine the number of participants who are eligible to participate in this study, but decline to participate in the study.

  through study completion, an average of 6 months

• Project Reach, total number of participants/patients who meet eligibility criteria

  Measurement in project reach will aid in the evaluation of the implementation process for the study, and will help us determine the feasibility of a larger study. Reach will be determined using the data from the EHR at CHS. Specifically, investigators will use data reports from the EHR to determine the total number of participants/patients who meet the eligibility criteria for the study.

  through study completion, an average of 6 months

• Intervention Session Completion

  Completion of the number of each intervention session will be documented in the EHR.

  through study completion, an average of 6 months

• Funds spent on FV deliveries

  Looking at total amount spent of FV deliveries will help us to identify if the fruit and vegetable prescription program was implemented as intended.

  through study completion, an average of 6 months

Secondary Outcomes (7)

• Demographics

  Baseline only

• Household Information

  Change from baseline and through study completion, an average of 6 months

• Food Purchasing and Household Food Availability

  Change from baseline and through study completion, an average of 6 months

• Food Security

  Change from baseline and through study completion, an average of 6 months

• Dietary Intake of Fruits and Vegetables

  Change from baseline and through study completion, an average of 6 months

Study Arms (1)

Prevention Plus

EXPERIMENTAL

Child's energy balance behavioral goals will be to consume \< 3 sugar-sweetened beverages (e.g., regular carbonated soft drinks, sports drinks, lemonades, ice teas, flavored milk, juice drinks \< 100% juice, and punches) servings /wk, ≥1 1/2 cups/day of whole vegetables and ≥ 1 cup/day of whole fruit, engage in ≥ 60 minutes/day of moderate- to vigorous-intensity physical activity, and reduce TV viewing to \< 2 hours/day. The caregiver's energy balance behavioral goals will be to consume \< 3 sugar-sweetened beverage servings/wk, ≥ 2 1/2 cups/day of whole vegetables and ≥ 1 1/2 cups/day of whole fruit, engage in ≥ 150 minutes of moderate- to vigorous-intensity physical activity per week and reduce TV viewing to \< 10 hours/wk.

Behavioral: Prevention Plus

Interventions

Prevention Plus BEHAVIORAL

Families will receive a behavioral intervention for childhood obesity provided by a BHC. This will consist of three, in-person meetings (months 1, 3, and 5), and three, 20-minute phone calls (months 2,4, and 6). During in-person visits, child height and weight will be taken, and BMI will be plotted on the BMI-for-age growth chart. During these sessions, families will receive feedback on child growth and weight status. Prevention Plus materials and child and caregiver energy balance behavior goals will be reviewed. The phone calls will be with the caregiver, where caregivers will be asked to measure the height and weight of their child, calculate BMI, and plot on the BMI-for-age growth chart. The BHC will discuss the family's progress on achieving child and caregiver goals and implementation of behavioral parenting strategies. Families will receive a fruit and vegetable prescription (FVx) in addition to the standard Prevention Plus family-based behavioral weight loss treatment.

Prevention Plus

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients at the Cherokee Health Systems clinic in Cherokee Mills
• Child age between 4 to 10 years old
• Child BMI \> 85th percentile
• Child must have an adult caregiver (\> 18 years) living in the household and be willing to participate in the program
• Adult caregivers need to be able to read and speak English

You may not qualify if:

• Not patients at the CHS Knox County Pediatric Clinic
• A child not within the 4 to 10 years age range
• Child BMI at or below the 85 percentile
• Child without an adult caregiver (\> 18 years) living in the household and not willing to participate in the program
• Adult caregivers that are not able to read and speak English

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead

Study Sites (2)

Cherokee Health Systems, Dameron Avenue Pedatrics

Knoxville, Tennessee, 37917, United States

RECRUITING

Healthy Eating and Activity Laboratory

Knoxville, Tennessee, 37996, United States

ENROLLING BY INVITATION

Related Publications (28)

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MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Hollie A Raynor, PhD

  University of Tennessee, Knoxville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hollie A Raynor, PhD

CONTACT

865-974-9126; hraynor@utk.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Research for the College of Education, Health, and Human Sciences

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 31, 2021
• Study Start: August 16, 2021
• Primary Completion: February 2, 2026
• Study Completion: February 28, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)