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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03026608
Other study ID # 12-1689
Secondary ID
Status Completed
Phase N/A
First received January 2, 2017
Last updated January 17, 2017
Start date September 2012
Est. completion date May 2016

Study information

Verified date December 2016
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 201
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Veggie Van Program
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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill University at Buffalo

Outcome

Type Measure Description Time frame Safety issue
Other Change in Body Mass Index measured via self-reported height and weight Change from baseline to 6 months
Primary Change in Fruit and Vegetable Consumption Measured via food frequency questionnaire Change from baseline to 6 months
Secondary 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. Change from baseline to 6 months
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