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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Communities randomized to the intervention group receive the Veggie Van program shortly after randomization.
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
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).
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University at Buffalo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings