NCT04246593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
759

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

June 5, 2025

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

3.7 years

First QC Date

October 22, 2019

Results QC Date

April 2, 2025

Last Update Submit

May 16, 2025

Conditions

Outcome Measures

Primary Outcomes (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.

    12 months

Secondary Outcomes (2)

  • Body Mass Index

    12 months

  • Dermal Carotenoids

    12 months

Other Outcomes (2)

  • Psychosocial Measures - Self-efficacy

    12 months

  • Psychosocial Measures - Benefits (Expectations)

    12 months

Study Arms (2)

Intervention - Market

EXPERIMENTAL

Partner 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.

Other: Mobile Market program implementation

Control - Planning

NO INTERVENTION

At 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.

Interventions

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

Intervention - Market

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts Avenue Project

Buffalo, New York, 14222, United States

Location

Related Publications (2)

  • 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.

  • 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.

Results Point of Contact

Title
Dr. Lucia Leone
Organization
State University of New York at Buffalo

Study Officials

  • Lucia Leone, Phd

    SUNY at Buffalo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 22, 2019

First Posted

January 29, 2020

Study Start

January 13, 2020

Primary Completion

October 11, 2023

Study Completion

October 11, 2023

Last Updated

June 5, 2025

Results First Posted

June 5, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations