- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03026608
Green Cart Program Evaluation
January 17, 2017 updated by: University of North Carolina, Chapel Hill
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
201
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Under 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Communities randomized to the intervention group receive the Veggie Van program shortly after randomization.
|
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
|
|
Active Comparator: Delayed Intervention Control Group
This group will receive the Veggie Van intervention approximately 6 months after baseline data collection and randomization (after the collection of 6 months outcomes data).
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fruit and Vegetable Consumption
Time Frame: Change from baseline to 6 months
|
Measured via food frequency questionnaire
|
Change from baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change Score for Perceived access to fresh fruits and vegetables
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Mass Index
Time Frame: Change from baseline to 6 months
|
measured via self-reported height and weight
|
Change from baseline to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Alice Ammerman, PhD, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
January 2, 2017
First Submitted That Met QC Criteria
January 17, 2017
First Posted (Estimate)
January 20, 2017
Study Record Updates
Last Update Posted (Estimate)
January 20, 2017
Last Update Submitted That Met QC Criteria
January 17, 2017
Last Verified
December 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 12-1689
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No plan to share individual data
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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