跳至主要内容
临床试验/NCT05502757
NCT05502757撤回不适用

Fresh Fruits and Vegetables for Families (or Fresh Families) Study

The University of Tennessee, Knoxville2 个研究点 分布在 1 个国家开始时间: 2022年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Number of vouchers used (VOUCHER group only)

研究概览

简要总结

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.

详细描述

Purpose/objectives of the study

Research has shown that children experiencing food insecurity are not meeting recommended intake of fruits and vegetables (FV). Cost and transportation/geographical barriers to accessing FV may be barriers that prevent these children from consuming recommended amounts of FVs. Food provision strategies, such as FV delivery or vouchers, may mitigate these barriers, assisting with increasing FV intake. Thus, efficacious strategies for food provision are needed for families with children who are experiencing food insecurity.

The purpose of this study is to see which food provision strategy, paper vouchers or home delivery, best increases FV availability at home and child FV intake.

Recruitment

For recruitment, flyers will be provided to interested elementary schools, daycare centers, Head Start locations, and community organizations within the 5-mile radius of the Western Ave Food City store. According to each organization's preference, paper flyers to hang and/or digital flyers to be distributed via listservs and/or social media will be provided. Flyers and listservs will also be used on the UTK and UTIA campuses, and study advertisements will be launched on Facebook. Additionally, summer meal sites (https://www.fns.usda.gov/meals4kids) will be contacted within the 5-mile radius to ask permission to handout study flyers at these events. Additionally, research staff will also set up recruitment tables at relevant family and community events, children's events and festivals, and health fairs in this zone. Recruitment flyers/advertisements will display a QR code that interested parents can scan using the camera app on their smartphone. The QR code will direct the parent to a brief Qualtrics survey that asks a few screening questions, collects contact information (caregiver name, phone number, and email), and obtains permission to be contacted by the research staff. Interested families will be contacted by the research team and screened for eligibility by phone. Eligible families will be then invited to an orientation. These orientations will be conducted virtually over Zoom. The orientations sessions will occur one-on-one between a family and a research team member. Families will be mailed/emailed the consent forms prior to the orientation. For families who are interested, the research team will review the consent form at the end of the orientation, and adult caregivers will sign consent forms and children will provide assent (verbal or written). Consent/assent forms will be collected via Qualtrics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Number of vouchers used (VOUCHER group only)

时间窗: 6 weeks

Total number of vouchers used by the participant

Purchase amount per delivery (DELIVERY group only)

时间窗: 6 weeks

The average purchase amount spent for each delivery

Total spent on fruits and vegetables (both groups)

时间窗: 6 weeks

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.)

Average amount of voucher value used (VOUCHER group only)

时间窗: 6 weeks

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

次要结局

  • Food Attitudes and Behaviors(At 6-week follow-up only)
  • Satisfaction Survey(At 6-week follow-up only)
  • Fruit and vegetable purchases(6 weeks)
  • Fruit and Vegetable Dietary Screener(6 weeks)
  • Demographics(Baseline only)
  • Caregiver BMI(Baseline only)
  • Fruit and vegetable home availability(6 weeks)
  • Types of fruits and vegetables purchased(6 weeks)
  • Child BMI z-scores(Baseline only)
  • Household information(6 weeks)
  • Food Security(6 weeks)

研究者

发起方
The University of Tennessee, Knoxville
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hollie Raynor

Associate Dean of Research

The University of Tennessee, Knoxville

研究点 (2)

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