Obesity
Conditions
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.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* Inclusion criteria for stores: 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 Inclusion criteria for wholesalers and producers: 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 Inclusion criteria for consumers (community members): * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stocking of Healthy Foods as Assessed by a Store Impact Questionnaire | Up to 2 months prior to intervention; up to 2 months post intervention | 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. |
| Change in Sale of Healthy Foods | Up to 2 months prior to intervention, up to 2 months post intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Purchasing of Healthy Foods by Consumers | Up to 2 months prior to intervention, up to 2 months post 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. 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. |
| Change in Consumption of Healthy Eating Index by Consumers | Up to 2 months prior to intervention, up to 2 months post 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. 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. |
| Estimated Changes (Reduction) in Operating Costs | Up to 2 months post intervention | 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). |
| Estimated Changes (Savings) in Acquisition Prices | Up to 2 months post intervention | 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. |
| Estimated Total Financial Expenses | Up to 2 months post intervention | 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). |
| Changes in Prices of Healthy Foods | Up to 2 months prior to intervention, up to 2 months post intervention | 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. |
| Change in Feasibility Metrics: App Satisfaction, Acceptability, Operability, and Perceived Sustainability as Assessed by Survey | Pre-intervention (baseline) up to approximately one year following completion of the intervention. | 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. |
| Process Metrics: Reach as Assessed by Intervention Corner-store Owners Who Participate in the Trial | Pre-intervention (baseline) up to 1 year following completion of 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 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). |
| Process Metrics: Dose Delivered | Up to 8 months | 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. |
| Subsidy Dollars Provided (Process Metrics: Fidelity) | Up to 8 months | 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. |
| Store Owners Using App (Process Metrics: Fidelity) | Up to 8 months | 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. |
| Number of Times Store Owners Used App (Process Metrics: Fidelity) | Up to 8 months | 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. |
Countries
United States
Contacts
Johns HopkinsUniversity
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention- Consumer Consumers living within 3/4 of a mile of intervention store | 16 |
| Control-Consumer Consumers living more than 3/4 of a mile from intervention stores. | 111 |
| Total | 127 |
Baseline characteristics
| Characteristic | Intervention- Consumer | Control-Consumer | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 110 Participants | 126 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 11 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 85 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 15 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 55 Participants | 65 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) White | 5 Participants | 44 Participants | 49 Participants |
| Sex: Female, Male Female | 13 Participants | 72 Participants | 85 Participants |
| Sex: Female, Male Male | 3 Participants | 39 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 127 |
| other Total, other adverse events | 0 / 20 | 0 / 127 |
| serious Total, serious adverse events | 0 / 20 | 0 / 127 |
Outcome results
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Cornerstore | Change in Sale of Healthy Foods | -0.03 healthy foods | Standard Deviation 0.58 |
| Intervention Cornerstore | Change in Sale of Healthy Foods | 0.50 healthy foods | — |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Cornerstore | Change in Stocking of Healthy Foods as Assessed by a Store Impact Questionnaire | -9.5 score on a scale | Standard Deviation 3.5 |
| Intervention Cornerstore | Change in Stocking of Healthy Foods as Assessed by a Store Impact Questionnaire | -2.2 score on a scale | Standard Deviation 2.7 |
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. The investigators will assess change in the consumption of healthy foods by subtracting the pre HEI score from the post HEI score.
Time frame: 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 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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Cornerstore | 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 |
| Intervention Cornerstore | Change in Feasibility Metrics: App Satisfaction, Acceptability, Operability, and Perceived Sustainability as Assessed by Survey | 1.667 Score on a scale | — |
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 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.
Time frame: 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
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Cornerstore | Changes in Prices of Healthy Foods | 3.6 US dollars | Standard Deviation 0.89 |
| Intervention Cornerstore | Changes in Prices of Healthy Foods | 2.0 US dollars | — |
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).
Time frame: Up to 2 months post intervention
Population: Analysis population represents corner stores with both baseline and post-intervention data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Cornerstore | Estimated Changes (Reduction) in Operating Costs | 4.00 US dollars | Standard Deviation 0.71 |
| Intervention Cornerstore | Estimated Changes (Reduction) in Operating Costs | 3.00 US dollars | — |
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.
Time frame: Up to 2 months post intervention
Population: Analysis population represents corner stores with both baseline and post-intervention data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Cornerstore | Estimated Changes (Savings) in Acquisition Prices | 3.8 US dollars | Standard Deviation 0.84 |
| Intervention Cornerstore | Estimated Changes (Savings) in Acquisition Prices | 5.0 US dollars | — |
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).
Time frame: Up to 2 months post intervention
Population: Analysis population represents corner stores with both baseline and post-intervention data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Cornerstore | Estimated Total Financial Expenses | 3.6 US dollars | Standard Deviation 0.55 |
| Intervention Cornerstore | Estimated Total Financial Expenses | 5.0 US dollars | — |
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/# planned, # promotional materials posted/# planned, and # subsidies provided/# planned.
Time frame: Measures collected during the trial will occur at pre-intervention, during the intervention and immediately after the intervention
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 such measurements as # store owners actively using the BUD app, # times they use the app, and # using materials/subsidies provided.
Time frame: Measures collected during the trial will occur at pre-intervention, during the intervention and immediately after the intervention
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).
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Cornerstore | Process Metrics: Reach as Assessed by Intervention Corner-store Owners Who Participate in the Trial | 4 Participants |
| Intervention Cornerstore | Process Metrics: Reach as Assessed by Intervention Corner-store Owners Who Participate in the Trial | 0 Participants |