Trial Outcomes & Findings for Effectiveness and Implementation of a Research Tested Mobile Produce Market (NCT NCT04246593)
NCT ID: NCT04246593
Last Updated: 2025-06-05
Results Overview
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.
COMPLETED
NA
759 participants
12 months
2025-06-05
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
426
|
273
|
|
Overall Study
COMPLETED
|
281
|
186
|
|
Overall Study
NOT COMPLETED
|
145
|
87
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
13
|
|
Overall Study
Lost to Follow-up
|
124
|
71
|
|
Overall Study
Moved out of area/became ineligible
|
3
|
1
|
|
Overall Study
Reason unknown
|
4
|
2
|
Baseline Characteristics
Number of participants analyzed is different from the overall population due to missing data from survey responses.
Baseline characteristics by cohort
| Measure |
Intervention - Market
n=426 Participants
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
|
Control - Planning
n=273 Participants
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.
|
Total
n=699 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=409 Participants • Number of participants analyzed is different from the overall population due to missing data from survey responses.
|
0 Participants
n=256 Participants • Number of participants analyzed is different from the overall population due to missing data from survey responses.
|
0 Participants
n=665 Participants • Number of participants analyzed is different from the overall population due to missing data from survey responses.
|
|
Age, Categorical
Between 18 and 65 years
|
359 Participants
n=409 Participants • Number of participants analyzed is different from the overall population due to missing data from survey responses.
|
197 Participants
n=256 Participants • Number of participants analyzed is different from the overall population due to missing data from survey responses.
|
556 Participants
n=665 Participants • Number of participants analyzed is different from the overall population due to missing data from survey responses.
|
|
Age, Categorical
>=65 years
|
50 Participants
n=409 Participants • Number of participants analyzed is different from the overall population due to missing data from survey responses.
|
59 Participants
n=256 Participants • Number of participants analyzed is different from the overall population due to missing data from survey responses.
|
109 Participants
n=665 Participants • Number of participants analyzed is different from the overall population due to missing data from survey responses.
|
|
Sex/Gender, Customized
Male
|
64 Participants
n=426 Participants
|
43 Participants
n=273 Participants
|
107 Participants
n=699 Participants
|
|
Sex/Gender, Customized
Female
|
359 Participants
n=426 Participants
|
230 Participants
n=273 Participants
|
589 Participants
n=699 Participants
|
|
Sex/Gender, Customized
Other/Refused/Missing
|
3 Participants
n=426 Participants
|
0 Participants
n=273 Participants
|
3 Participants
n=699 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=426 Participants
|
21 Participants
n=273 Participants
|
73 Participants
n=699 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
374 Participants
n=426 Participants
|
252 Participants
n=273 Participants
|
626 Participants
n=699 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=426 Participants
|
0 Participants
n=273 Participants
|
0 Participants
n=699 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=426 Participants
|
1 Participants
n=273 Participants
|
6 Participants
n=699 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=426 Participants
|
5 Participants
n=273 Participants
|
14 Participants
n=699 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=426 Participants
|
0 Participants
n=273 Participants
|
2 Participants
n=699 Participants
|
|
Race (NIH/OMB)
Black or African American
|
174 Participants
n=426 Participants
|
150 Participants
n=273 Participants
|
324 Participants
n=699 Participants
|
|
Race (NIH/OMB)
White
|
189 Participants
n=426 Participants
|
92 Participants
n=273 Participants
|
281 Participants
n=699 Participants
|
|
Race (NIH/OMB)
More than one race
|
17 Participants
n=426 Participants
|
10 Participants
n=273 Participants
|
27 Participants
n=699 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=426 Participants
|
15 Participants
n=273 Participants
|
45 Participants
n=699 Participants
|
|
Region of Enrollment
United States
|
426 participants
n=426 Participants
|
273 participants
n=273 Participants
|
699 participants
n=699 Participants
|
|
Body Mass Index (BMI)
|
30.58 kg/m^2
STANDARD_DEVIATION 7.46 • n=426 Participants
|
31.91 kg/m^2
STANDARD_DEVIATION 8.34 • n=273 Participants
|
31.1 kg/m^2
STANDARD_DEVIATION 7.83 • n=699 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Mobile Market Intervention Users
n=171 Participants
Many study participants that were randomized to the Intervention - Market arm of this study reported not attending the mobile market at least once; this is largely attributable to the significant impact of the COVID-19 pandemic in 2020, the year this study began recruitment. 171 intervention participants self-reported shopping at the Veggie Van at least once (40.1%).
|
Mobile Market Intervention Non-Users
n=369 Participants
Non-users include both those participants who were randomized to the intervention arm that reported never attending the Veggie Van mobile market intervention combined with those participants who were randomized to the Control - Planning (comparison) arm. These participants never received the intervention.
|
|---|---|---|
|
Consumption of Fruits and Vegetables
|
-0.24 servings/day
Standard Error 0.44
|
-0.13 servings/day
Standard Error 0.28
|
SECONDARY outcome
Timeframe: 12 monthsBMI 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
Outcome measures
| Measure |
Mobile Market Intervention Users
n=42 Participants
Many study participants that were randomized to the Intervention - Market arm of this study reported not attending the mobile market at least once; this is largely attributable to the significant impact of the COVID-19 pandemic in 2020, the year this study began recruitment. 171 intervention participants self-reported shopping at the Veggie Van at least once (40.1%).
|
Mobile Market Intervention Non-Users
n=34 Participants
Non-users include both those participants who were randomized to the intervention arm that reported never attending the Veggie Van mobile market intervention combined with those participants who were randomized to the Control - Planning (comparison) arm. These participants never received the intervention.
|
|---|---|---|
|
Body Mass Index
|
-0.05 Change in mean kg/m^2
Standard Error 0.77
|
-0.54 Change in mean kg/m^2
Standard Error 0.86
|
SECONDARY outcome
Timeframe: 12 monthsDermal 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.
Outcome measures
| Measure |
Mobile Market Intervention Users
n=42 Participants
Many study participants that were randomized to the Intervention - Market arm of this study reported not attending the mobile market at least once; this is largely attributable to the significant impact of the COVID-19 pandemic in 2020, the year this study began recruitment. 171 intervention participants self-reported shopping at the Veggie Van at least once (40.1%).
|
Mobile Market Intervention Non-Users
n=33 Participants
Non-users include both those participants who were randomized to the intervention arm that reported never attending the Veggie Van mobile market intervention combined with those participants who were randomized to the Control - Planning (comparison) arm. These participants never received the intervention.
|
|---|---|---|
|
Dermal Carotenoids
|
-22.19 score on a scale
Standard Error 29.89
|
5.83 score on a scale
Standard Error 31.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsSelf-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).
Outcome measures
| Measure |
Mobile Market Intervention Users
n=251 Participants
Many study participants that were randomized to the Intervention - Market arm of this study reported not attending the mobile market at least once; this is largely attributable to the significant impact of the COVID-19 pandemic in 2020, the year this study began recruitment. 171 intervention participants self-reported shopping at the Veggie Van at least once (40.1%).
|
Mobile Market Intervention Non-Users
n=166 Participants
Non-users include both those participants who were randomized to the intervention arm that reported never attending the Veggie Van mobile market intervention combined with those participants who were randomized to the Control - Planning (comparison) arm. These participants never received the intervention.
|
|---|---|---|
|
Psychosocial Measures - Self-efficacy
|
0.84 score on a scale
Standard Error 1.04
|
1.37 score on a scale
Standard Error 1.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsBenefits (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.
Outcome measures
| Measure |
Mobile Market Intervention Users
n=92 Participants
Many study participants that were randomized to the Intervention - Market arm of this study reported not attending the mobile market at least once; this is largely attributable to the significant impact of the COVID-19 pandemic in 2020, the year this study began recruitment. 171 intervention participants self-reported shopping at the Veggie Van at least once (40.1%).
|
Mobile Market Intervention Non-Users
n=53 Participants
Non-users include both those participants who were randomized to the intervention arm that reported never attending the Veggie Van mobile market intervention combined with those participants who were randomized to the Control - Planning (comparison) arm. These participants never received the intervention.
|
|---|---|---|
|
Psychosocial Measures - Benefits (Expectations)
|
-0.32 score on a scale
Standard Error 0.73
|
0.23 score on a scale
Standard Error 0.86
|
Adverse Events
Intervention - Market
Control - Planning
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lucia Leone
State University of New York at Buffalo
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place