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ObesityBUDNCT05010018

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

A study testing Web-based application connecting small food store owners and suppliers of healthier foods and beverages in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Web-based application connecting small food store owners and suppliers of healthier foods and beverages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
1 siteUnited States
Study dates
29 Oct 2021to 30 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Johns Hopkins University

    Baltimore, Maryland, 21218

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Obesity
Being tested
Web-based application connecting small food store owners and suppliers of healthier foods and beverages
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT05010018
Study groupRoleWhat they receive
InterventionExperimentalWe 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.
Receives: Behavioral: Web-based application connecting small food store owners and suppliers of healthier foods and beverages
ControlNo interventionWe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (12)
  1. Change in Purchasing of Healthy Foods by Consumers

    Adult consumer purchasing of healthy promoted foods and beverages will be captured by the adult impact questionnaire (AIQ) which will be conducted at baseline and post-treatment. Customers will be requested to report how often they purchased specific healthy promoted foods and beverages in the past 7 days, and where these foods were purchased. A score called the "Healthy Food Purchasing Score" will be calculated and have a possible score value ranging from 0-38 points. Higher score better. We will subtract the pre score from the baseline score to calculate change in purchasing of healthy foods by consumers.

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

  2. Change in Consumption of Healthy Eating Index by Consumers

    Adult customer consumption of healthy and unhealthy foods is captured by the semi-quantitative Block Food Frequency Questionnaire (FFQ) for the entire consumer sample. This validated questionnaire contains questions regarding the frequency and amount of consumption of over 50 commonly consumed foods. The Block FFQ has been validated for use in low income African American urban populations. Investigators will calculate a Healthy Eating Index (scoring ranging from 0-100) using the consumed food frequencies and portion sizes reported on the FFQ. Higher score better. The investigators will assess change in the consumption of healthy foods by subtracting the pre HEI score from the post HEI score.

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

  3. Estimated Changes (Reduction) in Operating Costs

    Data collection will include a Supplier Fixed and Variable Costs spreadsheet completed by the store owners which will provide information for the cost-benefit analysis of the treatment for each sector of the Baltimore food system participating in the BUD study. Respondents will be asked to estimate changes in these operating costs from before use of the app to the present. The team will compute savings in operating costs and the unit of measurement will be U.S $. It will consider the fixed and variable costs. Fixed costs will include item costs that will not change with the level of activity (rent of space; interest in long-term loans;). Variable costs will include item costs that change with level of activity (labor expenses; material expenses, transportation costs, utilities).

    Measured: Up to 2 months post intervention

  4. Estimated Changes (Savings) in Acquisition Prices

    The Supplier Fixed and Variable Costs spreadsheet completed by the store owners will provide information for the cost-benefit analysis of using the BUD app for each participating sector of the Baltimore food system. The quantity and price of acquisition will be observed and used to compute the total savings. The unit of measurement will be US dollars.

    Measured: Up to 2 months post intervention

  5. Estimated Total Financial Expenses

    The Supplier Fixed and Variable Costs spreadsheet completed by the store owners using the BUD app will provide information for estimated changes in total financial expenses. This data collection will include the financial costs of acquiring and implementing the BUD application. It will consider the fixed and variable costs. Fixed costs will include item costs that will not change with the level of activity (rent of space; cost items that need to be paid even if the producer close). Variable costs will include item costs that change with level of activity (labor expenses; material expenses, transportation costs, utilities). The unit of measurement will be U.S $ monthly, with adjustment (e.g., by total products).

    Measured: Up to 2 months post intervention

  6. Changes in Prices of Healthy Foods

    Prices of healthy promoted foods and beverages will be collected 5x, as well as of a subset of less healthy alternatives. The SIQ and process evaluation instruments will capture the price of each product during each visit, based on corner store owner report. Most corner stores do not label individual foods with the price, nor are shelves labeled. The investigators have successfully collected pricing information using this method for previous studies in Baltimore corner stores. The investigators will examine changes in prices from the point the food is sold at the store, until the end of the intervention. A change score will be calculated by subtracting the pre price from the post price of each healthy food. The investigators will use this information to compare prices of these healthier foods with those of unhealthy alternatives to help ensure acceptability to customers.

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

  7. Change in Feasibility Metrics: App Satisfaction, Acceptability, Operability, and Perceived Sustainability as Assessed by Survey

    Store-owner satisfaction with the BUD app was collected at two time points: pre-intervention (baseline) and post-intervention. Corner store owners using the BUD app were asked to rate their agreement with multiple statements related to app usability, perceived benefit, operational feasibility, and competitive advantage. Each item used a 5-point Likert response scale (1 = strongly disagree to 5 = strongly agree), the total composite score ranges from 3-15 with higher scores better, indicating greater satisfaction. A composite satisfaction score was calculated at each time point, and change was computed as the post-intervention score minus the baseline score.

    Measured: Pre-intervention (baseline) up to approximately one year following completion of the intervention.

  8. Process Metrics: Reach as Assessed by Intervention Corner-store Owners Who Participate in the Trial

    During intervention delivery, the investigators will assess multiple process evaluation metrics. These will be recorded via in-person data collection, or through the BUD app itself. The first process measures is reach which is measured by the # intervention store owners who actively participate in trial ( # who access BUD app at least once).

    Measured: Pre-intervention (baseline) up to 1 year following completion of the intervention.

  9. Process Metrics: Dose Delivered

    During intervention delivery, the investigators will assess multiple process evaluation metrics. These will be recorded via in-person data collection, or through the BUD app itself. The second process measure is dose delivered which includes trainings completed by JHU team, promotional materials posted, and subsidies provided.

    Measured: Up to 8 months

  10. Subsidy Dollars Provided (Process Metrics: Fidelity)

    During intervention delivery, the investigators will assess multiple process evaluation metrics. These will be recorded via in-person data collection, or through the BUD app itself. The third process measure is fidelity which includes amount of subsidy dollars provided.

    Measured: Up to 8 months

  11. Store Owners Using App (Process Metrics: Fidelity)

    During intervention delivery, the investigators will assess multiple process evaluation metrics. These will be recorded via in-person data collection, or through the BUD app itself. The third process measure is fidelity which includes number of store owners actively using the BUD app.

    Measured: Up to 8 months

  12. Number of Times Store Owners Used App (Process Metrics: Fidelity)

    During intervention delivery, the investigators will assess multiple process evaluation metrics. These will be recorded via in-person data collection, or through the BUD app itself. The third process measure is fidelity which includes number of times (sessions) store owners use the BUD app.

    Measured: Up to 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start29 Oct 2021
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05010018
Sponsor's protocol ID
5R34HL145368
Other IDs
R34HL145368
Acronym
BUD
Status last verified
Jul 2026
First submitted
22 Jul 2021
Last updated
17 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 38323147
  • 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.

    PubMed 35897500

Questions about this trial

What is this clinical trial studying?

A study testing Web-based application connecting small food store owners and suppliers of healthier foods and beverages in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Stocking of Healthy Foods as Assessed by a Store Impact Questionnaire (time frame: Up to 2 months prior to intervention; up to 2 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05010018, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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