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Fruit and Vegetable ConsumptionNCT03026608

Green Cart Program Evaluation

A study testing Veggie Van Program in people with Fruit and Vegetable Consumption and Food Insecurity, run by University of North Carolina, Chapel Hill.

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

The Green Car Evaluation was designed to test the impact of the Veggie Van mobile produce market on access to healthy food and fruit and vegetable intake in 12 lower-income communities using a cluster-randomized design. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Veggie Van Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
No sites listed yet
Study dates
Sep 2012to May 2016
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Receives services or lives within one of the communities selected for the study
  • Main shopper for the household
  • Intends to use Veggie Van if it comes to their community

Who cannot join

  • Under 18

About this study

Official title: Impact of a Public-Private Mobile Market to Improve Fruit & Vegetable Access

The Green Car Evaluation was designed to test the impact of the Veggie Van mobile produce market on access to healthy food and fruit and vegetable intake in 12 lower-income communities using a cluster-randomized design.

Read the detailed description

Lower-income and minority groups face significant health disparities with respect to obesity, cancer, heart disease and other chronic conditions. Poor diets, low in fruits and vegetables (F\&V) and high in saturated fat, sodium and sugar, contribute to many of the health problems faced by vulnerable groups. While poverty, low-educational attainment and personal food preference are all associated with reduced F\&V consumption, these individual-level factors must be viewed in an environmental context. Research has repeatedly demonstrated the important role that environment plays on health decisions and behaviors. Compared with higher-income neighborhoods, lower-income and minority neighborhoods are less likely to have a supermarket that sells a variety of F\&V and other healthy foods. This is perpetuated by an underlying misconception that there is limited demand or potential profit for new healthy food ventures in these communities. In the few cases where new food outlets have opened in underserved areas, they have been met with substantial customer support. The NC Green Cart program, which our team has already been funded to lead, uses a weekly mobile market model to deliver low-cost boxes of fresh F\&V to easily accessible community locations (such as churches and day care centers) and provide nutrition and cooking education. This program builds upon burgeoning support for a local sustainable food system in NC and leverages a public-private partnership to increase access to fresh F\&V in underserved communities. While current program funding allows for minimal evaluation, the present study hopes to demonstrate that selling affordable, accessible F\&V in lower-income communities is not only financially viable, but can impact behavioral risk factors of individuals in target communities. Working together with the Green Cart program team, this research will 1.) measure the impact of a mobile market at 6, 12 and 18 months on the primary outcome of F\&V consumption as well as BMI, perceived access to F\&V, and self-efficacy to purchase, prepare, serve and eat fresh F\&V using a randomized controlled design; and 2.) assess community support, feasibility, and financial sustainability of the public-private Green Cart partnership. Results of this research will inform our understanding of how the food environment impacts dietary choices and provide evidence for researchers, businesses, non-profits and policy makers on the potential impact and viability of using similar models to reduce food access disparities and improve diet.

Being tested
Veggie Van Program

What participants receive

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

  • Veggie Van ProgramBehavioural

    This includes 1.) Weekly delivery of fresh local produce; 2.) Cooking and nutrition demonstrations; 3.) Weekly newsletters about cooking, nutrition and local produce mailed to all study participants and distributed at Veggie Van

Study groups in NCT03026608
Study groupRoleWhat they receive
Intervention GroupExperimentalCommunities randomized to the intervention group receive the Veggie Van program shortly after randomization.
Receives: Behavioral: Veggie Van Program
Delayed Intervention Control GroupActive comparatorThis group will receive the Veggie Van intervention approximately 6 months after baseline data collection and randomization (after the collection of 6 months outcomes data).
Receives: Behavioral: Veggie Van Program

What is being measured

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

  1. Change in Fruit and Vegetable Consumption

    Measured via food frequency questionnaire

    Measured: Change from baseline to 6 months

Secondary outcomes (1)
  1. Change Score for Perceived access to fresh fruits and vegetables

    At each time point, a three-question perceived access scale was used to measure participants' perceptions of access to fresh fruits and vegetables in (1) their neighborhood, (2) the area surrounding the VV community site, and (3) in general. Questions included 1) "It is easy to buy fresh fruits and vegetables [in my neighborhood/around community sites/ in general];" 2) "There is a large selection of fresh fruits and vegetables [in my neighborhood/around community site/in general];" 3) "The fresh fruits and vegetables [in my neighborhood/around community site/in general] are high quality." For all perceived access questions, participants chose responses from a 5-point Likert scale ranging from "Strongly Agree" = 5 to "Strongly Disagree" = 1. Each three item scaled was summed to create a perceived access score by location (range 3-15). Higher scores at each time point indicate higher perceived access and positive changes indicate increases in access from baseline to 6 months.

    Measured: Change from baseline to 6 months

Timeline

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

  1. First posted20 Jan 2017 (estimated)
  2. Study startSep 2012
  3. Primary completionMay 2016
  4. Study completionMay 2016

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03026608
Sponsor's protocol ID
12-1689
Status last verified
Dec 2016
First submitted
2 Jan 2017
Last updated
20 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No: No plan to share individual data

Publications

  • Leone LA, Tripicchio GL, Haynes-Maslow L, McGuirt J, Grady Smith JS, Armstrong-Brown J, Gizlice Z, Ammerman A. Cluster randomized controlled trial of a mobile market intervention to increase fruit and vegetable intake among adults in lower-income communities in North Carolina. Int J Behav Nutr Phys Act. 2018 Jan 5;15(1):2. doi: 10.1186/s12966-017-0637-1.

    PubMed 29304862

Questions about this trial

What is this clinical trial studying?

A study testing Veggie Van Program in people with Fruit and Vegetable Consumption and Food Insecurity, run by University of North Carolina, Chapel Hill.

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 3 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Fruit and Vegetable Consumption (time frame: Change from baseline to 6 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 NCT03026608, which also lists 1 linked publication.

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 20 Jan 2017.

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