A Mobile Application to Improve Procurement and Distribution of Healthful Foods & Beverages in Baltimore City

NCT ID: NCT05010018

Last Updated: 2026-01-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-29

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Web-based application connecting small food store owners and suppliers of healthier foods and beverages

Intervention Type BEHAVIORAL

The primary intervention is a web-based app that connects small food store owners in low income Baltimore with suppliers of healthier foods and beverages. To reduce costs associated with small purchasing quantities by corner stores, and high delivery charges, the BUD app uses collective purchasing and shared delivery strategies. BUD will be implemented in four stages, where each stage promotes different food/beverage items and introduces new features. The app will be bundled with a small subsidy in stages 1-2 to encourage initial use, increase familiarity with the app and reduce risk. Trainings in the use of the app will take place at the beginning of each phase. BUD will use collective purchasing at stage 2 of implementation (BuddyUp!). The BuddyLift! feature will start in stage 3, enabling small store owners to deliver BuddyUp! deals to other stores for an additional discount. Participating stores and wholesalers will receive point of purchase materials to promote BUD products.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Web-based application connecting small food store owners and suppliers of healthier foods and beverages

The primary intervention is a web-based app that connects small food store owners in low income Baltimore with suppliers of healthier foods and beverages. To reduce costs associated with small purchasing quantities by corner stores, and high delivery charges, the BUD app uses collective purchasing and shared delivery strategies. BUD will be implemented in four stages, where each stage promotes different food/beverage items and introduces new features. The app will be bundled with a small subsidy in stages 1-2 to encourage initial use, increase familiarity with the app and reduce risk. Trainings in the use of the app will take place at the beginning of each phase. BUD will use collective purchasing at stage 2 of implementation (BuddyUp!). The BuddyLift! feature will start in stage 3, enabling small store owners to deliver BuddyUp! deals to other stores for an additional discount. Participating stores and wholesalers will receive point of purchase materials to promote BUD products.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


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


* 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)

Exclusion Criteria

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

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joel Gittlesohn, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns HopkinsUniversity

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Lewis EC, Zhu S, Oladimeji AT, Igusa T, Martin NM, Poirier L, Trujillo AJ, Reznar MM, Gittelsohn J. Design of an innovative digital application to facilitate access to healthy foods in low-income urban settings. Mhealth. 2023 Nov 3;10:2. doi: 10.21037/mhealth-23-30. eCollection 2024.

Reference Type DERIVED
PMID: 38323147 (View on PubMed)

Gittelsohn J, Lewis EC, Martin NM, Zhu S, Poirier L, Van Dongen EJI, Ross A, Sundermeir SM, Labrique AB, Reznar MM, Igusa T, Trujillo AJ. The Baltimore Urban Food Distribution (BUD) App: Study Protocol to Assess the Feasibility of a Food Systems Intervention. Int J Environ Res Public Health. 2022 Jul 26;19(15):9138. doi: 10.3390/ijerph19159138.

Reference Type DERIVED
PMID: 35897500 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol with Stat Plan

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Other Identifiers

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R34HL145368

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R34HL145368

Identifier Type: NIH

Identifier Source: org_study_id

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