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| ID | Type | Description | Link |
|---|---|---|---|
| 5R37CA215232-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Market program implementation | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Dermal Carotenoids |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial Measures - Self-efficacy | Self-efficacy to purchase, prepare and eat fresh F&V were measured using a 10-point Likert scale, where 10 indicates easiest (most self-efficacy, better outcome) and 1 indicates hardest (least self-efficacy, worse outcome), applied to a selection of 8 items adapted from a study of shoppers where self-efficacy was shown to be correlated with nutrition behaviors and will serve as a comprehensive assessment of the effect of the educational intervention. The 8 items' scores were summed to create a total self-efficacy score ranging from 8 (least total self-efficacy, worse outcome) to 80 (most total self-efficacy, better outcome) for each participant. The measured outcome is the difference between the mean baseline total self-efficacy score and the mean follow-up total self-efficacy score for each group (change). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucia Leone, Phd | SUNY at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Avenue Project | Buffalo | New York | 14222 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42396526 | Derived | 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. | |
| 42064881 | Derived | 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. |
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Of 759 eligible participants enrolled in the study, 699 were included in analysis as 60 participants were removed because the partner organization operating the intervention/delayed-intervention control sites they were assigned to dropped out of the study.
Community-based organizations selected as study partners facilitated participant recruitment through a 2-month community engagement period prior to the intervention. If recruitment goals were not met, recruitment continued for up to two months after the intervention period started. Intervention/delayed-intervention control activities occurred at partner sites on a rolling basis; the first participant was enrolled January 13, 2020 and the last was enrolled September 25, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention - Market | 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. Mobile Market program implementation: 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 |
| FG001 | Control - Planning | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention - Market | 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. Mobile Market program implementation: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number of participants analyzed is different from the overall population due to missing data from survey responses. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The food environment and shopping behaviors were significantly impacted by the COVID-19 pandemic in 2020. Many intervention participants did not attend the mobile market. We analyzed the data according to participants' self-reported intervention usage. We combined intervention participants who reported never using the intervention with the Control - Planning (comparison) arm participants, as these participants all did not receive/use the intervention. | Posted | Mean | Standard Error | servings/day | 12 months |
1 year
This is a low risk study. We do not anticipate any harm to the participants. Study staff reported adverse events to the PI within 24 hours and the PI reported all adverse events in accordance with the policy of the UB IRB. Because of this low risk status, the data safety monitoring plan (DSMP) focused on close monitoring, along with prompt reporting of excessive adverse events and any serious adverse events to the NIH and to the IRB. Recruitment, drop-out, and missing data will be reviewed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention - Market | 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. Mobile Market program implementation: 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lucia Leone | State University of New York at Buffalo | (716) 829-6040 | lucialeo@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 13, 2022 | Apr 1, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2025 | Mar 31, 2025 | SAP_001.pdf |
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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. |
| 12 months |
| 12 months |
| Psychosocial Measures - Benefits (Expectations) | Benefits (expectations) and barriers to eating F&V were measured with 12 questions using a 4-point Likert scale (1 indicates strongly disagree, 2 indicates disagree, 3 indicates agree, and 4 indicates strongly agree) previously tested in lower-income adults which reflects common benefits/barriers found in the literature. The 12 individual question scores were summed to generate the total barriers score, with a minimum score of 12 (strongly disagree) and a maximum score of 48 (strongly agree). For all scales, a higher number indicates higher perceived barriers and therefore a worse outcome. The lower the score the better the outcome. | 12 months |
| 41957873 | Derived | 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. |
| 41377950 | Derived | 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. |
| 36011468 | Derived | 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. |
| Moved out of area/became ineligible |
|
| Reason unknown |
|
| BG001 | Control - Planning | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Error | Change in mean kg/m^2 | 12 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | 12 months |
|
|
|
|
| Other Pre-specified | Psychosocial Measures - Self-efficacy | Self-efficacy to purchase, prepare and eat fresh F&V were measured using a 10-point Likert scale, where 10 indicates easiest (most self-efficacy, better outcome) and 1 indicates hardest (least self-efficacy, worse outcome), applied to a selection of 8 items adapted from a study of shoppers where self-efficacy was shown to be correlated with nutrition behaviors and will serve as a comprehensive assessment of the effect of the educational intervention. The 8 items' scores were summed to create a total self-efficacy score ranging from 8 (least total self-efficacy, worse outcome) to 80 (most total self-efficacy, better outcome) for each participant. The measured outcome is the difference between the mean baseline total self-efficacy score and the mean follow-up total self-efficacy score for each group (change). | Posted | Mean | Standard Error | score on a scale | 12 months |
|
|
|
|
| Other Pre-specified | Psychosocial Measures - Benefits (Expectations) | Benefits (expectations) and barriers to eating F&V were measured with 12 questions using a 4-point Likert scale (1 indicates strongly disagree, 2 indicates disagree, 3 indicates agree, and 4 indicates strongly agree) previously tested in lower-income adults which reflects common benefits/barriers found in the literature. The 12 individual question scores were summed to generate the total barriers score, with a minimum score of 12 (strongly disagree) and a maximum score of 48 (strongly agree). For all scales, a higher number indicates higher perceived barriers and therefore a worse outcome. The lower the score the better the outcome. | Posted | Mean | Standard Error | score on a scale | 12 months |
|
|
|
|
| 0 |
| 426 |
| 0 |
| 426 |
| 0 |
| 426 |
| EG001 | Control - Planning | 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. | 0 | 273 | 0 | 273 | 0 | 273 |
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| Other/Refused/Missing |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|