Clinical trial NCT04246593: Effectiveness and Implementation of a Research Tested Mobile Produce Market
Official title: Effectiveness and Implementation of a Research Tested Mobile Produce Market Designed to Improve Diet in Underserved Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fruit and Vegetable Consumption
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: National Cancer Institute (NCI)
First posted: 2020-01-29
Enrollment: 759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigators will test the effectiveness of the Veggie Van model across multiple organizations and sites using a cluster-randomized design and will document the implementation process to understand what factors are associated with dietary change and sustainability.

Detailed description: After 9 qualified organizations have been identified among applicants, investigators will randomize proposed Mobile Market (MM) sites (33 total across all partner organizations), to an intervention (Mobile Market program implementation) or comparison condition (extended planning). Randomization will be stratified within each organization so that each organization will have 2 intervention and 2 comparison sites. One organization will have 5 sites. The 5th site will allow for more thorough testing of protocol procedures. This ensures that study groups will be balanced at the organizational level. The condition for which each proposed MM location was selected will be communicated at the time of award. Organizations will communicate to intervention sites that they want to open a MM at that location within the next year. Organizations will communicate to comparison sites that they want to work with them on a food systems planning process to determine if a MM program is the right fit for their location. At the end of the year-long planning process with comparison sites, the organization and proposed MM site will decide together how to proceed (start a MM, apply for grant funding for a different project; etc.).

Both arms will undergo community engagement efforts that serve to both identify potential research participants and engage them in the planning for a MM. Intervention sites will work with a community advisory committee to develop an engagement plan to raise community awareness of the forthcoming MM.

Comparison sites will work with a community advisory committee to engage community members in a food access planning process.

Both intervention and comparison sites will distribute interest forms as part of the community engagement process.Research staff will identify from the interest forms those interested in participating in the study. Consent will be obtained via phone. Phone surveys and in-person data collection will then be completed.

* Baseline and 12 month Follow-Up Survey will include dietary-related psychosocial measures These surveys will be administered over the phone.
* The main individual-level outcome, change in Fruits and Veggies (F\&V) intake at 12 months, will be measured through four 24-hour recalls (2 at baseline and 2 at 12 months) which will be administered over the phone by trained interviewers. One recall at each time point will be from a weekday and the other from a weekend day. Recalls will be collected using the Nutrition Data Systems for Research (NDSR) computer-based software application. A participant will receive The Food Amounts Booklet via mail after the baseline survey to have as a visual reference for the 24-hour recalls.
* In addition to survey data, body mass index (BMI) and dermal carotenoids will be measured at in-person data collection events at baseline and 12 months.

Market (Intervention Sites) will implement a Mobile Market, weekly, for at least 10 months that will follow the Veggie Van model that includes 3 research supported components:

* "Share" model: Similar to community supported agriculture, this model selects fresh, high quality produce available from local farmers, creates "shares" of 5-8 types of produce, and delivers to community sites once per week. Customers can also choose to purchase individual produce items; however, based on focus group discussions with customers, it is believed that the share model is a key factor in increasing consumption of a larger quantity and variety of Fruits and Veggies. It also contributes to program sustainability by allowing Mobile Markets to better predict their sales and reduce waste.
* Incentives: Prices for a Veggie Van model vary slightly by market location. In some communities, only one reduced price (i.e., lower than market value) is offered. In other communities, where customers are of mixed socioeconomic status, partners offer shares on a sliding scale. Customers can use their ebt card, credit/debit, cash or check to purchase produce shares. To support the subsidized cost of produce for low-income residents, the Veggie Van model offers a full-cost box delivery service to workplaces and schools. However, other communities may be able to take advantage of incentive programs (such as Double Up Food Bucks) to offer reduced costs to those eligible.
* Educational Component: The Veggie Van model has a curriculum that consists of monthly themes (e.g., Eating in Season, Healthy Snacks, MyPlate, Reducing Sugar) and weekly lessons which build upon those themes. The lessons are designed to be delivered at the Mobile Market while customers are on line waiting to make a purchase. Accompanying newsletters help reinforce lesson plans and also include information about storing and preparing the produce items in the box that week. Newsletters include seasonal recipes and when possible, cooking demonstrations of these recipes or taste tests of featured produce items are offered at the Mobile Market Partner site.

Eligibility criteria: Inclusion Criteria:

* at least 18 years old, speak English or Spanish
* the primary grocery shopper for their household
* interested in having more healthy food retail options at or around the proposed Mobile Market site
* either frequent the proposed Mobile Market site regularly or live near by

Exclusion Criteria:

* Individuals will be excluded if they do not meet the above inclusion criteria. They will be excluded if they are planning to leave the area or stop using the proposed Mobile Market site (intervention participants) within the next year.

Primary outcomes:
measure: Consumption of Fruits and Vegetables
timeFrame: 12 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: 12 months
measure: Dermal Carotenoids
timeFrame: 12 months
Other outcomes:
measure: Psychosocial Measures - Self-efficacy
timeFrame: 12 months
measure: Psychosocial Measures - Benefits (Expectations)
timeFrame: 12 months
Locations:
city: Buffalo
country: United States
facility: Massachusetts Avenue Project
state: New York
Study officials:
affiliation: SUNY at Buffalo
name: Lucia Leone, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vermont LN, Kasprzak C, Lally A, Claudio A, Tumiel-Berhalter L, Haynes-Maslow L, Ammerman A, Raja S, Leone LA. A Randomized Controlled Trial of a Research-Tested Mobile Produce Market Model Designed to Improve Diet in Under-Resourced Communities: Rationale and Design for the Veggie Van Study. Int J Environ Res Public Health. 2022 Aug 10;19(16):9832. doi: 10.3390/ijerph19169832.