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.
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
- Conditions the study is for
- Fruit and Vegetable Consumption, Food Insecurity
- What is being tested?
- Veggie Van Program
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Fruit and Vegetable Consumption, Food Insecurity
- 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 group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Communities randomized to the intervention group receive the Veggie Van program shortly after randomization. Receives: Behavioral: Veggie Van Program |
| Delayed Intervention Control Group | Active comparator | 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). Receives: Behavioral: Veggie Van Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fruit and Vegetable Consumption
Measured via food frequency questionnaire
Measured: Change from baseline to 6 months
Secondary outcomes (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.
- First posted20 Jan 2017 (estimated)
- Study startSep 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fruit and Vegetable ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo
- Responsible party
- Sponsor
- Investigators
- Alice Ammerman, PhD, Principal investigator, University of North Carolina, Chapel Hill
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Public-Private Mobile Market to Improve Fruit & Vegetable Access
- ClinicalTrials.gov ID
- NCT03026608
- Acronym / sponsor ID
- 12-1689
- Conditions
- Fruit and Vegetable Consumption, Food Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University at Buffalo
- Study start
- Sep 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Veggie Van ProgramCommunities randomized to the intervention group receive the Veggie Van program shortly after randomization. |
| Delayed Intervention Control Group | Active comparator | Behavioral: Veggie Van ProgramThis group will receive the Veggie Van intervention approximately 6 months after baseline data collection and randomization (after the collection of 6 months outcomes data). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Veggie Van ProgramThis 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 | Behavioural | Delayed Intervention Control Group, Intervention Group |
Primary outcome
Change in Fruit and Vegetable Consumption
Time frame: Change from baseline to 6 months
Measured via food frequency questionnaire
1 secondary outcome
Change Score for Perceived access to fresh fruits and vegetables
Time frame: Change from baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Derived from this study: PubMed 29304862Leone 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.
- Individual participant dataSharing planned: No. No plan to share individual data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Ammerman, PhD principal investigator
University of North Carolina, Chapel Hill
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.