NCT05010018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 29, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 14, 2026

Completed
Last Updated

January 14, 2026

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

July 22, 2021

Results QC Date

October 21, 2025

Last Update Submit

December 22, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

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

    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.

    Up to 2 months prior to intervention; up to 2 months post intervention

  • Change in Sale of Healthy Foods

    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.

    Up to 2 months prior to intervention, up to 2 months post intervention

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

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.

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

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.

Interventions

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

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Obesity

Interventions

Beverages

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Joel Gittelsohn
Organization
Johns Hopkins University

Study Officials

  • Joel Gittlesohn, PhD

    Johns HopkinsUniversity

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2021

First Posted

August 18, 2021

Study Start

October 29, 2021

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

January 14, 2026

Results First Posted

January 14, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Requests would be reviewed by the project steering committee (composed of study investigators and the appropriate NIH project officer). They will receive de-identified data spreadsheets with codebooks that explain the meaning of each variable and the corresponding codes for each variable. In addition, they will receive a detailed description of the study design.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
People may request data for research purposes, after data have been collected, cleaned, analyzed and the primary study outcome papers have been published.
Access Criteria
External parties would be required to complete an online request form, describing the specific datasets required, intended use/analyses, commitment to confidentiality, etc.

Locations