Clinical trial NCT05010018: A Mobile Application to Improve Procurement and Distribution of Healthful Foods & Beverages in Baltimore City
Official title: A Mobile Application to Improve Procurement and Distribution of Healthful Foods & Beverages in Low Income Urban Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-08-18
Enrollment: 290
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in stocking of healthy and unhealthy foods
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
measure: Change in sales of healthy and unhealthy foods
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. Measures collected during the trial will occur at the end of each stage of intervention.
Secondary outcomes:
measure: Change in purchasing of healthy foods by consumers
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
measure: Change in consumption of Healthy Eating Index by consumers
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
measure: Estimated changes (reduction) in operating costs
timeFrame: This measure will be made in the two months after the end of the intervention only via interview.
measure: Estimated changes (savings) in acquisition prices
timeFrame: This measure will be made in the two months after the end of the intervention via interview only.
measure: Estimated total financial expenses
timeFrame: This measure will be made in the two months after the end of the intervention only via interview.
measure: Changes in prices of healthy foods
timeFrame: The Pre measure will be made in the two months prior to starting the intervention or at the time of introduction; the Post measure will be made in the two month after the end of the intervention.
measure: Feasibility Metrics: User Satisfaction Acceptability, operability, perceived sustainability and user satisfaction with the BUD app Acceptability, operability, perceived sustainability and user satisfaction with the BUD app
timeFrame: Measures collected during the trial will occur at pre-intervention, during the intervention and immediately after the intervention
measure: Process Metrics: Reach
timeFrame: Measures collected during the trial will occur at pre-intervention, during the intervention and immediately after the intervention
measure: Process Metrics: Dose Delivered
timeFrame: Measures collected during the trial will occur at pre-intervention, during the intervention and immediately after the intervention
measure: Process Metrics: Fidelity
timeFrame: Measures collected during the trial will occur at pre-intervention, during the intervention and immediately after the intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns HopkinsUniversity
name: Joel Gittlesohn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.