- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04246593
Effectiveness and Implementation of a Research Tested Mobile Produce Market
Effectiveness and Implementation of a Research Tested Mobile Produce Market Designed to Improve Diet in Underserved Communities
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Leah Vermont, MS
- Phone Number: 7168296681
- Email: leahverm@buffalo.edu
Study Locations
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New York
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Buffalo, New York, United States, 14222
- Massachusetts Avenue Project
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Consumption of Fruits and Vegetables
Time Frame: 12 months
|
Change in Fruit & Vegetable (F&V) intake (cups/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.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index
Time Frame: 12 months
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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
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12 months
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Dermal Carotenoids
Time Frame: 12 months
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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.
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12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychosocial measures - Self-efficacy
Time Frame: 12 months
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Self-efficacy to purchase, prepare and eat fresh F&V and will be measured with a 10-point Likert scale using a selection of 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.
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12 months
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Psychosocial measures - Benefits (expectations)
Time Frame: 12 months
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Benefits (expectations) and barriers to eating F&V will be measured using a 4-point Likert scale (strongly agree, agree, disagree, strongly disagree) previously tested in lower-income adults which reflects common benefits/barriers found in the literature.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lucia Leone, Phd, SUNY at Buffalo
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1144594
- 5R37CA215232-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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