跳至主要内容
临床试验/NCT07039630
NCT07039630暂停不适用

A Sustainable Nutrition Security Intervention for Low-Income Households

Roswell Park Cancer Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年11月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
50
试验地点
1
主要终点
Change in nutrition security

研究概览

简要总结

This study is being done to see how produce delivery with or without nutritional education affects what people eat and if it can help improve diet and nutrition in low-income families and their ability to get enough healthy food. Research shows strong evidence regarding the role of diet in new cancer rates and cancer deaths. Although dietary guidelines have been established at the national level to improve diet quality, the average dietary quality remains low in American households, particularly in low-income communities. These disadvantaged communities are also more likely to be food insecure (having limited or uncertain access to nutritious food). FreshFix is a community-based organization that provides nutritious foods from local farmers to communities in Western New York and offers a Half-Price Produce delivery program which is targeted for lower-income and underserved communities. Participating in the FreshFix program with access to nutritional education materials may decrease food insecurity and improve diet quality in low-income families.

详细描述

PRIMARY OBJECTIVES:

I. To develop a nutrition security intervention to improve the nutrition security of low-income households.

II. To determine the feasibility of the nutrition security intervention.

SECONDARY OBJECTIVE:

I. To refine the intervention by engaging community-based organizations and households enrolled in the nutrition security intervention to ascertain the barriers and facilitators of intervention implementation.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lives in Western New York (WNY)
  • Is the person responsible for at least half of the food purchasing and preparation
  • Categorized as having marginal, low of very low food security
  • Able to access to internet and e-mail/text messages
  • Speaks and understands English

排除标准

  • Participants that are unable to speak and understand English
  • Participants that are unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant(s) is/are an unsuitable candidate to receive the study

研究组 & 干预措施

Arm I (enhanced food box, educational materials, call)

Experimental

Participants receive enhanced delivery half-price food boxes delivered by a community health worker and assistance on the proper handling and storage of the food over 24 weeks on study. Participants receive nutritional education materials and access to additional educational resources on the FreshFix online ordering platform. Participants also receive a dietary recall phone call at baseline and at 6 months on study.

干预措施: Questionnaire Administration (Other)

Arm I (enhanced food box, educational materials, call)

Experimental

Participants receive enhanced delivery half-price food boxes delivered by a community health worker and assistance on the proper handling and storage of the food over 24 weeks on study. Participants receive nutritional education materials and access to additional educational resources on the FreshFix online ordering platform. Participants also receive a dietary recall phone call at baseline and at 6 months on study.

干预措施: Telephone-Based Intervention (Behavioral)

Arm II (standard food box)

Active Comparator

Participants receive the standard half-price produce box delivery delivered by FreshFix staff over 24 weeks on study.

干预措施: Food Assistance Programs (Behavioral)

Arm II (standard food box)

Active Comparator

Participants receive the standard half-price produce box delivery delivered by FreshFix staff over 24 weeks on study.

干预措施: Survey Administration (Other)

Arm I (enhanced food box, educational materials, call)

Experimental

Participants receive enhanced delivery half-price food boxes delivered by a community health worker and assistance on the proper handling and storage of the food over 24 weeks on study. Participants receive nutritional education materials and access to additional educational resources on the FreshFix online ordering platform. Participants also receive a dietary recall phone call at baseline and at 6 months on study.

干预措施: Food Assistance Programs (Behavioral)

Arm I (enhanced food box, educational materials, call)

Experimental

Participants receive enhanced delivery half-price food boxes delivered by a community health worker and assistance on the proper handling and storage of the food over 24 weeks on study. Participants receive nutritional education materials and access to additional educational resources on the FreshFix online ordering platform. Participants also receive a dietary recall phone call at baseline and at 6 months on study.

干预措施: Health Promotion and Education (Other)

Arm I (enhanced food box, educational materials, call)

Experimental

Participants receive enhanced delivery half-price food boxes delivered by a community health worker and assistance on the proper handling and storage of the food over 24 weeks on study. Participants receive nutritional education materials and access to additional educational resources on the FreshFix online ordering platform. Participants also receive a dietary recall phone call at baseline and at 6 months on study.

干预措施: Survey Administration (Other)

Arm II (standard food box)

Active Comparator

Participants receive the standard half-price produce box delivery delivered by FreshFix staff over 24 weeks on study.

干预措施: Questionnaire Administration (Other)

结局指标

主要结局

Change in nutrition security

时间窗: Baseline to 24 weeks

Diet quality will be assessed by recall interview administered through the Nutrition Data System for Research.

Intervention acceptability

时间窗: At 24 weeks

Conducted at 24 week follow up via phone or text based survey

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

A Food Security Intervention for the Prevention of... | 临床试验