Viewing Study NCT05010018


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Study NCT ID: NCT05010018
Status: COMPLETED
Last Update Posted: 2025-10-17
First Post: 2021-07-22
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: A Mobile Application to Improve Procurement and Distribution of Healthful Foods & Beverages in Baltimore City
Sponsor: Johns Hopkins Bloomberg School of Public Health
Organization:

Study Overview

Official Title: A Mobile Application to Improve Procurement and Distribution of Healthful Foods & Beverages in Low Income Urban Communities
Status: COMPLETED
Status Verified Date: 2025-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BUD
Brief Summary: 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.
Detailed Description: 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
R34HL145368 NIH None https://reporter.nih.gov/quic… View