Trial Outcomes & Findings for A Mobile Application to Improve Procurement and Distribution of Healthful Foods & Beverages in Baltimore City (NCT NCT05010018)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

310 participants

Primary outcome timeframe

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

Results posted on

2026-01-14

Participant Flow

Recruitment occurred in 2021-2023 for corner stores and food-store consumers. Corner store recruitment occurred at the individual stores. Food-store consumer recruitment occurred via flyers at stores and on social media.

Of the 290 participants enrolled, 163 participants recruited into the study were later found out to be "bots" and thus their data was removed from the study and they were not assigned into study arms. 127 food-store consumers were assigned to the study arms. 20 stores were recruited into the study and 16 finished. 2 stores closed and 2 were converted into restaurants.

Unit of analysis: Corner stores

Participant milestones

Participant milestones
Measure	Intervention Intervention corner-store; Consumers living within 3/4 of a mile of intervention store	Control Corner stores in the control arm do not receive the application. Consumers living more than 3/4 of a mile from intervention stores.
Overall Study STARTED	16 4	111 16
Overall Study Corner-store Owners	4 4	16 16
Overall Study COMPLETED	6 2	52 14
Overall Study NOT COMPLETED	10 2	59 2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention- Consumer n=16 Participants Consumers living within 3/4 of a mile of intervention store	Control-Consumer n=111 Participants Consumers living more than 3/4 of a mile from intervention stores.	Total n=127 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=14 Participants	110 Participants n=10 Participants	126 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=14 Participants	1 Participants n=10 Participants	1 Participants n=24 Participants
Sex: Female, Male Female	13 Participants n=14 Participants	72 Participants n=10 Participants	85 Participants n=24 Participants
Sex: Female, Male Male	3 Participants n=14 Participants	39 Participants n=10 Participants	42 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	2 Participants n=10 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=14 Participants	2 Participants n=10 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	2 Participants n=10 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Black or African American	10 Participants n=14 Participants	55 Participants n=10 Participants	65 Participants n=24 Participants
Race (NIH/OMB) White	5 Participants n=14 Participants	44 Participants n=10 Participants	49 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=14 Participants	6 Participants n=10 Participants	7 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=14 Participants	11 Participants n=10 Participants	11 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=14 Participants	85 Participants n=10 Participants	99 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=14 Participants	15 Participants n=10 Participants	17 Participants n=24 Participants

PRIMARY outcome

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

Population: Corner-stores are the analysis group. Food-store consumers (participants) were not the analysis group for this outcome. The Overall Number of Participants Analyzed represents the number of corner-store owners for each Arm/Group.

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.

Outcome measures

Outcome measures
Measure	Control Cornerstore n=14 Corner store Corner store that did not use the app	Intervention Cornerstore n=2 Corner store Cornerstore that used the app
Change in Stocking of Healthy Foods as Assessed by a Store Impact Questionnaire	-9.5 score on a scale Standard Deviation 3.5	-2.2 score on a scale Standard Deviation 2.7

PRIMARY outcome

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

Population: Analysis population represents corner stores with both baseline and post-intervention data collected

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.

Outcome measures

Outcome measures
Measure	Control Cornerstore n=5 Corner store Corner store that did not use the app	Intervention Cornerstore n=1 Corner store Cornerstore that used the app
Change in Sale of Healthy Foods	-0.03 healthy foods Standard Deviation 0.58	0.50 healthy foods Standard Deviation NA Standard deviation is NA because the intervention arm contains only one store owner

SECONDARY outcome

Timeframe: 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

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 in a sample of 190 regular customers (5 customers/store in 19 intervention and 19 control stores). 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. We will subtract the pre score from the baseline score to calculate change in purchasing of healthy foods by consumers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

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. The investigators will assess change in the consumption of healthy foods by subtracting the pre HEI score from the post HEI score.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 months post intervention

Population: Analysis population represents corner stores with both baseline and post-intervention data collected

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).

Outcome measures

Outcome measures
Measure	Control Cornerstore n=5 Corner store Corner store that did not use the app	Intervention Cornerstore n=1 Corner store Cornerstore that used the app
Estimated Changes (Reduction) in Operating Costs	4.00 US dollars Standard Deviation 0.71	3.00 US dollars Standard Deviation NA Standard deviation is NA because the intervention arm contains only one store.

SECONDARY outcome

Timeframe: Up to 2 months post intervention

Population: Analysis population represents corner stores with both baseline and post-intervention data collected

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.

Outcome measures

Outcome measures
Measure	Control Cornerstore n=5 Corner store Corner store that did not use the app	Intervention Cornerstore n=1 Corner store Cornerstore that used the app
Estimated Changes (Savings) in Acquisition Prices	3.8 US dollars Standard Deviation 0.84	5.0 US dollars Standard Deviation NA Standard deviation is NA because the intervention arm contains only one store.

SECONDARY outcome

Timeframe: Up to 2 months post intervention

Population: Analysis population represents corner stores with both baseline and post-intervention data collected

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).

Outcome measures

Outcome measures
Measure	Control Cornerstore n=5 Corner store Corner store that did not use the app	Intervention Cornerstore n=1 Corner store Cornerstore that used the app
Estimated Total Financial Expenses	3.6 US dollars Standard Deviation 0.55	5.0 US dollars Standard Deviation NA Standard deviation is NA because the intervention arm contains only one store.

SECONDARY outcome

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

Population: Analysis population represents corner stores with both baseline and post-intervention data collected

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.

Outcome measures

Outcome measures
Measure	Control Cornerstore n=5 Corner store Corner store that did not use the app	Intervention Cornerstore n=1 Corner store Cornerstore that used the app
Changes in Prices of Healthy Foods	3.6 US dollars Standard Deviation 0.89	2.0 US dollars Standard Deviation NA Standard deviation is NA because the intervention arm contains only one store

SECONDARY outcome

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

Population: Analysis population represents corner store owners with both baseline and post-intervention data collected

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.

Outcome measures

Outcome measures
Measure	Control Cornerstore n=5 Participants Corner store that did not use the app	Intervention Cornerstore n=1 Participants Cornerstore that used the app
Change in Feasibility Metrics: App Satisfaction, Acceptability, Operability, and Perceived Sustainability as Assessed by Survey	-0.133 Score on a scale Standard Deviation 1.17	1.667 Score on a scale Standard Deviation NA Standard deviation is NA because the intervention arm contains only one store owner

SECONDARY outcome

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

Population: Corner-store owners with data collected in the intervention arm who received and used the app

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).

Outcome measures

Outcome measures
Measure	Control Cornerstore n=4 Participants Corner store that did not use the app	Intervention Cornerstore Cornerstore that used the app
Process Metrics: Reach as Assessed by Intervention Corner-store Owners Who Participate in the Trial	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Measures collected during the trial will occur at pre-intervention, during the intervention and immediately after the intervention

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/# planned, # promotional materials posted/# planned, and # subsidies provided/# planned.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measures collected during the trial will occur at pre-intervention, during the intervention and immediately after the intervention

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 such measurements as # store owners actively using the BUD app, # times they use the app, and # using materials/subsidies provided.

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joel Gittelsohn

Johns Hopkins University

Phone: 1-410-274-5310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place