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临床试验/NCT05010018
NCT05010018已完成不适用

A Mobile Application to Improve Procurement and Distribution of Healthful Foods & Beverages in Low Income Urban Communities

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2021年10月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
310
试验地点
1
主要终点
Change in Stocking of Healthy Foods as Assessed by a Store Impact Questionnaire

研究概览

简要总结

Low-income urban communities have many small food stores, but poor access to healthier foods and beverages. The investigators will develop, implement and evaluate the feasibility of a Baltimore Urban food Distribution (BUD) web-based application (app) to improve access to affordable, healthier products from local producers/wholesalers in 38 urban corner stores in low-income Baltimore neighborhoods, using a randomized controlled trial design and assess its impact on store stocking and sales. The R34 will provide a developed and tested version of the BUD app, which will resolve challenges related to affordability and delivery of healthful foods and beverages to small food stores, permit development of new instruments, assess potential impacts at the consumer level, permitting power and sample size estimates for the full-scale clinical trial, and demonstrate the investigators' ability to recruit and retain large numbers of wholesalers, producers, and corner stores in low-income urban settings.

详细描述

The overarching goal of this application is to develop and pilot test a web-based application (app) that will increase access to healthier foods and beverages in low-income urban communities in the United States. Small retail food stores are ubiquitous in low-income urban settings throughout the US and present a unique opportunity to supply surrounding neighborhoods with healthful food options. However, these small stores usually carry few or no foods that are both healthy and affordable. A primary barrier to stocking healthy, affordable foods in small urban food stores is the lack of an adequate distribution network; small store owners generally need to travel on their own to obtain healthy foods and beverages for their stores. Low access to healthy food and high access to food with low nutritional value have been associated with poor diet quality, obesity and chronic disease in many studies.

The study team has worked for more than 17 years in Baltimore to develop, implement, and evaluate chronic disease prevention programs by improving the food environment in low-income communities. The investigators' preliminary formative research assessed the initial acceptability of a mobile app that will enable small urban food store owners to access a range of healthy foods from local wholesalers and producers, and facilitate affordable delivery to their stores. The study team found high acceptability for an app that would leverage the collective purchasing power of digitally-networked small food stores and introduce cost efficiencies into food delivery. For this NHLBI Clinical Trial Pilot Study (R34), the investigators propose to develop a working web-based Baltimore Urban food Distribution (BUD) app, pilot the app, and evaluate its feasibility and impact on the availability, prices and distribution of healthful foods and beverages in East Baltimore, with the following primary aims: 1) To develop and optimize a technically stable and functional digital strategy to overcome small retail food system constraints common in low-income urban food settings; 2) To pilot the BUD app with Baltimore-based producers/wholesalers and corner stores, and assess its feasibility (i.e., acceptability, operability, perceived sustainability, user satisfaction); and 3) To evaluate the impact of the BUD app on corner store stocking (availability, timeliness, quality), prices, and sales of healthy and unhealthy foods and beverages in a pilot study employing a randomized controlled trial design of 38 corner stores. Secondary aims will examine impact on consumers and a cost-benefit analysis for participating retailers and producers.

Findings will permit the investigators to: 1) produce a functional and acceptable web-based app, 2) provide preliminary data needed for power calculations for the full-scale trial, 3) generate and refine process evaluation instruments and set standards for implementation, and 4) establish protocols and demonstrate the study team's ability to recruit and retain large numbers of wholesalers, producers, corner stores and consumers. The study team will assess generalizability of the app by conducting feasibility assessments of the developed app with small store owners and suppliers in other urban settings. The findings from this R34 application are essential to support a full-scale clinical trial, which will test a multi-city deployment of the BUD app and assess its impact on obesity and diet.

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
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for stores:
  • Store owner/manager willing and able to order food through a smart phone or other internet-enabled device
  • Store owner/manager willing to attend in-store trainings in the use of the BUD App
  • Store located in a low-income neighborhood considered as a Healthy Food Priority Area by the Johns Hopkins Center for a Livable Future111 in East Baltimore
  • Store located >0.25 miles from a supermarket
  • Store classified as a small food store (< 4 aisles, < 2 cash registers)
  • Store owner/manager is English, Korean, Spanish or Mandarin-speaking for first language
  • Inclusion criteria for wholesalers and producers:
  • Provide service to Baltimore City (e.g., for producers, this could mean participating in Baltimore City-based farmers markets)
  • Willing to use the BUD app, including posting and maintaining data on a minimum number of products
  • Willing to participate with delivery services arranged
  • Inclusion criteria for consumers (community members):
  • Regular customers of the store (purchase food items at least once a week in the store) identified by the small food store owner/manager enrolled in the study
  • Adult (between 21 years old and 75 years old)
  • Live/work within a 1/2 mile radius from one of the 38 small food stores participating in the study
  • Live in a household of at least 2 persons (criteria intended to provide a more stable sample, to reduce loss to follow-up)

排除标准

  • Anticipate moving out of Baltimore City in the next 12 months
  • Pregnant (due to changes in diet, weight and body composition)

研究组 & 干预措施

Control

No Intervention

We will collect data from 19 control corner stores over the same 8-month period. They will not receive any form of intervention or delay intervention.

Intervention

Experimental

We will pilot the BUD app in 19 intervention corner stores over an 8-month period in East Baltimore. During this time, we will collect data from corner store owners, producers, whole salers, and consumers.

干预措施: Web-based application connecting small food store owners and suppliers of healthier foods and beverages (Behavioral)

结局指标

主要结局

Change in Stocking of Healthy Foods as Assessed by a Store Impact Questionnaire

时间窗: Up to 2 months prior to intervention; up to 2 months post intervention

Stocking of healthy foods will be assessed from Pre to Post intervention at participating corner stores. A Store Impact Questionnaire will capture the number of promoted foods and beverages stocked during each visit, based on direct structured observation of corner store shelves. The investigators will create healthy food availability scores (range 0-27). The investigators will calculate change scores, by subtracting each pre measure from each post measure. A higher score is better, indicates more healthy options became available over the intervention.

Change in Sale of Healthy Foods

时间窗: Up to 2 months prior to intervention, up to 2 months post intervention

Change in sale of promoted healthy foods will be assessed from Pre to Post intervention at participating corner stores (recall over the last 30 day period). Store owners will be asked to recall the sale of selected healthy foods over the last 30 day period.

次要结局

  • Process Metrics: Fidelity(Measures collected during the trial will occur at pre-intervention, during the intervention and immediately after the intervention)
  • Process Metrics: Dose Delivered(Measures collected during the trial will occur at pre-intervention, during the intervention and immediately after the intervention)
  • Change in Purchasing of Healthy Foods by Consumers(Up to 2 months prior to intervention, up to 2 months post intervention)
  • Change in Consumption of Healthy Eating Index by Consumers(Up to 2 months prior to intervention, up to 2 months post intervention)
  • Process Metrics: Dose Delivered(Up to 8 months)
  • Subsidy Dollars Provided (Process Metrics: Fidelity)(Up to 8 months)
  • Store Owners Using App (Process Metrics: Fidelity)(Up to 8 months)
  • Number of Times Store Owners Used App (Process Metrics: Fidelity)(Up to 8 months)
  • Change in Purchasing of Healthy Foods by Consumers(The Pre measure will be made in the two months prior to starting the intervention; the Post measure will be made in the two month after the end of the intervention)
  • Change in Consumption of Healthy Eating Index by Consumers(The Pre-measure will be made in the two months prior to starting the intervention; the Post-measure will be made in the two month after the end of the intervention)
  • Estimated Changes (Reduction) in Operating Costs(Up to 2 months post intervention)
  • Estimated Changes (Savings) in Acquisition Prices(Up to 2 months post intervention)
  • Estimated Total Financial Expenses(Up to 2 months post intervention)
  • Changes in Prices of Healthy Foods(Up to 2 months prior to intervention, up to 2 months post intervention)
  • Change in Feasibility Metrics: App Satisfaction, Acceptability, Operability, and Perceived Sustainability as Assessed by Survey(Pre-intervention (baseline) up to approximately one year following completion of the intervention.)
  • Process Metrics: Reach as Assessed by Intervention Corner-store Owners Who Participate in the Trial(Pre-intervention (baseline) up to 1 year following completion of the intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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