NCT03026608

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
Last Updated

January 20, 2017

Status Verified

December 1, 2016

Enrollment Period

3.7 years

First QC Date

January 2, 2017

Last Update Submit

January 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Fruit and Vegetable Consumption

    Measured via food frequency questionnaire

    Change from baseline to 6 months

Secondary Outcomes (1)

  • Change Score for Perceived access to fresh fruits and vegetables

    Change from baseline to 6 months

Other Outcomes (1)

  • Change in Body Mass Index

    Change from baseline to 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Communities randomized to the intervention group receive the Veggie Van program shortly after randomization.

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).

Behavioral: Veggie Van Program

Interventions

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

Delayed Intervention Control GroupIntervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Officials

  • Alice Ammerman, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 20, 2017

Study Start

September 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 20, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

No plan to share individual data