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Fruit and Vegetable ConsumptionNCT04246593

Effectiveness and Implementation of a Research Tested Mobile Produce Market

A study testing Mobile Market program implementation in people with Fruit and Vegetable Consumption, run by University at Buffalo 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

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Fruit and Vegetable Consumption
What is being tested?
Mobile Market program implementation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
759 participants
Where
1 siteUnited States
Study dates
13 Jan 2020to 11 Oct 2023
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts Avenue Project

    Buffalo, New York, 14222

Other trials in United States

About this study

Official title: Effectiveness and Implementation of a Research Tested Mobile Produce Market Designed to Improve Diet in Underserved Communities

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.

Read the 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.
Being tested
Mobile Market program implementation

What participants receive

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

  • Mobile Market program implementationOther

    Mobile Market program implementation includes utilizing a Veggie Van model which sells reduced cost locally-grown produce in communities with barriers to accessing fresh F\&Vs because of availability, cost, or lack of produce preparation skills.The Veggie Van visits sites that already serve the target market (e.g., lower-income housing communities, community health centers, community colleges). While Mobile Market programs vary in their model and operation, we believe that the three components of Veggie Van's success are it's "share" model, price reductions (incentives), and educational component

Study groups in NCT04246593
Study groupRoleWhat they receive
Intervention - MarketExperimentalPartner sites that are randomized to the "Intervention - Market" will plan and start (or expand) a Mobile Market and run the Market weekly for at least 10 months (non necessarily nonconsecutive). The Mobile Market will follow the Veggie Van Model which includes a "share model", price reductions (incentives), and an educational component.
Receives: Other: Mobile Market program implementation
Control - PlanningNo interventionAt Control - Planning (comparison) sites, engagement will focus on involving community members in food access program planning and research. It is anticipated that each organization will create one or more community advisory committees to oversee their food access work. At comparison sites, engagement efforts will be more generally centered on food access and understanding what types of programs would be most acceptable. Examples of community engagement activities include community forums and listening sessions, informational tables at community events, and establishment of text, e-mail or social media sites for ongoing communication and feedback around food access issues. As part of this community engagement work, partners will collect contact information from community members that will assist in the data collection process.

What is being measured

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

  1. Consumption of Fruits and Vegetables

    Change in Fruit \& Vegetable (F\&V) intake (servings/day) at 12 months will be calculated from four 24-hour recalls (2 at baseline and 2 at 12-months) which will be administered over the phone by trained interviewers (in English or Spanish). One recall at each time point will be from a weekday and the other from a weekend day. The 24-hour dietary recalls will be collected using the Nutrition Data Systems for Research (NDSR) computer-based software application developed at the University of Minnesota Nutrition Coordinating Center (NCC); NDSR uses a five pass interview approach with interview prompts in English and Spanish (49). The NCC Food and Nutrient Database serves as the source of food composition information in NDSR (50). When a participant completes their in-person data collection, participants will receive The Food Amounts Booklet to have as a visual reference during the 24-hour recall. This booklet is compatible with the NDSR program.

    Measured: 12 months

Secondary outcomes (2)
  1. Body Mass Index

    BMI will be calculated at baseline and 12 months from weight measured using a Seca 876 digital scale (maximum capacity of 250 kg) and height measured to the nearest 1/8 inch using a Seca stadiometer. Weight and height will be combined to report BMI in kg/m^2

    Measured: 12 months

  2. Dermal Carotenoids

    Dermal Carotenoids will be measured using a finger scan technology called the "Veggie Meter" which relies on pressure mediated Raman Spectroscopy (RS) and is thought to be a valid indicator of changes in skin carotenoids in response to dietary carotenoid consumption. Dermal Carotenoids are measured on a scale of 0 to 800, with 0 representing the absence of dermal carotenoids and 800 representing the maximum possible score for dietary carotenoids. A higher dermal carotenoid score indicates a greater presence of dietary carotenoids, and as such a better outcome. Change between baseline and follow-up scores will be calculated for each group.

    Measured: 12 months

Timeline

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

  1. First posted29 Jan 2020
  2. Study start13 Jan 2020
  3. Primary completion11 Oct 2023
  4. Study completion11 Oct 2023

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04246593
Sponsor's protocol ID
1144594
Other IDs
5R37CA215232-02
Status last verified
May 2025
First submitted
22 Oct 2019
Last updated
5 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kasprzak C, Paluch R, Tumiel-Berhalter L, Raja S, Lelone L. Is the level of implementation linked with intervention outcomes? The process evaluation of the Veggie Van intervention to increase fruit and vegetable consumption in underserved communities. Res Sq [Preprint]. 2026 Jun 24:rs.3.rs-9889528. doi: 10.21203/rs.3.rs-9889528/v1.

    PubMed 42396526
  • Kasprzak C, Canizares A, Lally A, Vermont LN, Tumiel-Berhalter L, Raja S, Haynes-Maslow L, Ammerman A, Leone LA. Protocol for the process evaluation of a mobile produce market intervention to increase fruit and vegetable consumption in lower-income communities: the Veggie Van Study. Front Public Health. 2026 Apr 15;14:1760383. doi: 10.3389/fpubh.2026.1760383. eCollection 2026.

    PubMed 42064881
  • Leone LA, Kasprzak C, Lally Mathiebe A, Paluch R, Haynes-Maslow L, Raja S, Tumiel-Berhalter L, Vermont LN, Ammerman A. Cluster-randomized controlled trial of a mobile produce market designed to address diet and food insecurity in underserved communities. BMC Nutr. 2026 Apr 9;12(1):94. doi: 10.1186/s40795-026-01302-7.

    PubMed 41957873
  • Leone LA, Kasprzak C, Lally A, Paluch R, Haynes-Maslow L, Raja S, Tumiel-Berhalter L, Vermont LN, Ammerman A. Cluster-Randomized Controlled Trial of a Mobile Produce Market designed to Address Diet and Food Insecurity in Underserved Communities. Res Sq [Preprint]. 2025 Dec 2:rs.3.rs-7860050. doi: 10.21203/rs.3.rs-7860050/v1.

    PubMed 41377950
  • 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.

    PubMed 36011468

Questions about this trial

What is this clinical trial studying?

A study testing Mobile Market program implementation in people with Fruit and Vegetable Consumption, run by University at Buffalo 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 4 inclusion and 1 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 5 Jun 2025. 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 5 Jun 2025). 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?

Consumption of Fruits and Vegetables (time frame: 12 months). 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 NCT04246593, which also lists 5 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 5 Jun 2025.

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