Fruit & Vegetable Provision Study

NCT05502757 | Withdrawn

• 1 other identifier: UTK IRB-22-06985-XP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Fresh Families is a research study being conducted by the Healthy Eating and Activity Laboratory at the UT Dept of Nutrition. The purpose of this study is to see which food provision strategy, paper vouchers or home delivery, best increases fruit and vegetable (FV) availability at home and child FV intake. The study will enroll families experiencing household food insecurity with children 4-17 years who do not meet recommendations for FV intake and have an adult caregiver (18+ years) willing to participate. Families will be randomized to one of two groups: voucher group or home delivery group. Families in the voucher group will be provided 6, $15 paper vouchers ($90 total) for the purchase of fresh FV at a partnering Food City location in Knoxville, TN. Families in the home delivery group will be provided access to an online Food City account to purchase up to $90 fresh FV for home delivery, delivered by research staff at the time of their choosing. Each group will have 6 weeks to utilize their vouchers/funds, and then they will expire. There will also be one appointment to collect child and caregiver height and weight at the family's home.

Conditions

Food Security

Keywords

Food provision

Outcome Measures

Primary Outcomes (4)

• Total spent on fruits and vegetables (both groups)

  For the VOUCHER group, research staff will work with the partner Food City to determine total amount spent on fresh fruits and vegetables using vouchers. For the DELIVERY group, research staff will retain all grocery receipts to determine the total amount used. (Up to $90 for both groups.)

  6 weeks

• Number of vouchers used (VOUCHER group only)

  Total number of vouchers used by the participant

  6 weeks

• Average amount of voucher value used (VOUCHER group only)

  The average amount of money used from each voucher (up to $15 per voucher)

  6 weeks

• Purchase amount per delivery (DELIVERY group only)

  The average purchase amount spent for each delivery

  6 weeks

Secondary Outcomes (11)

• Child BMI z-scores

  Baseline only

• Caregiver BMI

  Baseline only

• Demographics

  Baseline only

• Household information

  6 weeks

• Fruit and vegetable purchases

  6 weeks

Study Arms (2)

Provision of paper FV vouchers (VOUCHER) condition

EXPERIMENTAL

Families in the VOUCHER condition will be provided 6, $15 paper vouchers ($90 total) for the purchase of fresh FV at a partnering Food City location in Knoxville, TN.

Other: Fruit and vegetable provision

Home delivery of fresh FV (DELIVERY) condition

EXPERIMENTAL

Families in the DELIVERY condition will be provided access to an online Food City account to purchase up to $90 fresh FV for home delivery, delivered by research staff at the time of their choosing.

Other: Fruit and vegetable provision

Interventions

Fruit and vegetable provision OTHER

Fresh fruits and vegetables are provided to families at no cost

Home delivery of fresh FV (DELIVERY) condition; Provision of paper FV vouchers (VOUCHER) condition

Eligibility Criteria

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

You may qualify if:

• Families experiencing food insecurity
• Live within a 5-mile radius of the partnering Food City location
• Have a child 4 to 17 years of age
• Adult (\> 18 years) caregiver living in the household willing to participate in the program will be eligible
• Adult caregiver must be able to read and speak English
• Adult caregiver willing to shop for fresh FV at the partnering Food City location

You may not qualify if:

• Families with children who currently meet current recommendations for FV intake (i.e., ≥4.5 cups of FV/day, based on Dietary Guideline for Americans 2020-2025 Healthy US-Style Dietary Pattern for Ages 2 and Older)

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead

Study Sites (1)

Healthy Eating and Activity Lab, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Publications (4)

• Haynes-Maslow L, Parsons SE, Wheeler SB, Leone LA. A qualitative study of perceived barriers to fruit and vegetable consumption among low-income populations, North Carolina, 2011. Prev Chronic Dis. 2013;10:E34. doi: 10.5888/pcd10.120206.

  PMID: 23489639 BACKGROUND

• Bihan H, Mejean C, Castetbon K, Faure H, Ducros V, Sedeaud A, Galan P, Le Clesiau H, Peneau S, Hercberg S. Impact of fruit and vegetable vouchers and dietary advice on fruit and vegetable intake in a low-income population. Eur J Clin Nutr. 2012 Mar;66(3):369-75. doi: 10.1038/ejcn.2011.173. Epub 2011 Oct 12.

  PMID: 21989324 BACKGROUND

• Jones LJ, VanWassenhove-Paetzold J, Thomas K, Bancroft C, Ziatyk EQ, Kim LS, Shirley A, Warren AC, Hamilton L, George CV, Begay MG, Wilmot T, Tsosie M, Ellis E, Selig SM, Gall G, Shin SS. Impact of a Fruit and Vegetable Prescription Program on Health Outcomes and Behaviors in Young Navajo Children. Curr Dev Nutr. 2020 Jul 21;4(8):nzaa109. doi: 10.1093/cdn/nzaa109. eCollection 2020 Aug.

  PMID: 32734135 BACKGROUND

• Locher I, Waselewski M, Sonneville K, Resnicow K, Chang T. Grocery Delivery of Healthy Foods to Pregnant Young Women With Low Incomes: Feasibility and Acceptability Mixed Methods Study. JMIR Form Res. 2020 Dec 24;4(12):e21602. doi: 10.2196/21602.

  PMID: 33361055 BACKGROUND

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hollie A Raynor, PhD RD LDN

  University of Tennessee Knoxville, Department of Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Research

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 16, 2022
• Study Start: June 14, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)