NCT02729675

Brief Summary

The purpose of this project is to study the efficacy of a delivery system to offer fresh fruits and vegetables (F\&V) at discount prices for purchase at worksites in conjunction with educational interventions on increasing employees' F\&V consumption in comparison to an intervention receiving fruit and vegetable markets alone or a comparison intervention.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,804

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_2

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, 2010

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
Last Updated

April 6, 2016

Status Verified

March 1, 2016

Enrollment Period

5.1 years

First QC Date

March 29, 2016

Last Update Submit

March 31, 2016

Conditions

Keywords

fruit & vegetable, market, education, worksite, food access

Outcome Measures

Primary Outcomes (2)

  • Change in Fruit and Vegetable Intake

    Measured by National Cancer Institute Eating at America's Table All Day Screener

    Baseline, 6 and 12 months

  • Change in Fruit and Vegetable Intake

    Two-Item Cup F\&V intake screener

    Baseline, 6 and 12 months

Secondary Outcomes (1)

  • Change in fruit and vegetable eating behaviors

    Baseline, 6 and 12 months

Study Arms (3)

Access Intervention

EXPERIMENTAL

Worksites in this condition received weekly Fruit and Vegetable markets

Other: Access Intervention

Enhanced Intervention

EXPERIMENTAL

Worksites in this condition received weekly Fruit and Vegetable markets and Educational Interventions including Campaigns, Newsletters, DVDs, A Website, and Chef Demonstrations

Other: Access InterventionBehavioral: Enhanced Intervention

Comparison Intervention

ACTIVE COMPARATOR

Worksites in this condition received Stress and Physical Activity Interventions

Behavioral: Comparison Behavioral Intervention

Interventions

The 7 worksites in this arm received year-round, weekly mobile F\&V markets (Fresh To You - FTY) selling local and non-local fresh produce at or below local supermarket prices. The markets carried 50 to 70 different produce items and were held both indoors and outdoors depending on the weather and worksite preference. When held indoors, F\&V were sold in a cafeteria or other highly trafficked area. In good weather, the markets were held outside on the worksite property in a retrofitted a car trailer. Each market lasted two hours. On average, FTY prices were 15% to 25% lower than local retail supermarket prices. Signs, posters, email blasts and flyers advertised the markets. The FTY intervention at each worksite began with a Kick-Off event, which included the first FTY market. Each employee who attended the first market received a large, reusable shopping bag with the FTY logo on it and a freezer pack to keep F\&V fresh.

Also known as: Fresh to You Fruit and Vegetable Mobile Market Intervention
Access InterventionEnhanced Intervention

The 7 worksites in this arm received the Access intervention described above as well as set of educational/behavioral interventions. At the Kick-Off, employees received the first month's newsletter and an educational digital video disk (DVD) in the reusable shopping bag. They also received a chef-run cooking demonstration/taste-testing along with recipes and information about the upcoming intervention activities. Intervention activities included two 6-week campaigns (Just Add Two and Choose Color, Choose Health); a 90 minute DVD with cooking demonstrations about preparing quick, healthy inexpensive meals and unusual F\&V; a two-page, full-color newsletter distributed monthly; Food demonstrations/tastings delivered once a month by chefs including an easy to prepare, F\&V-based recipe; a total of 12 recipe handouts that correlated with the monthly cooking demonstration; a Good to Go website; and a project bulletin board.

Also known as: Educational plus Access Intervention
Enhanced Intervention

Brown University contracted with the Greater Providence Young Men's Christian Association (YMCA) to provide a physical activity and stress reduction intervention at the 7 worksites in the comparison group. Two, six-week campaigns were developed jointly by the Brown study team and YMCA staff. These campaigns followed the same format as the enhanced intervention group campaigns and were provided during the same time periods as those at the enhanced intervention sites. Everyone who participated in the campaigns also received a free, 6-week membership to the YMCA.

Also known as: Attention Placebo Control
Comparison Intervention

Eligibility Criteria

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

You may qualify if:

  • works at least 25 hours per week at the worksite
  • is on-site at least half of every day shift during the week
  • reads and understands English.

You may not qualify if:

  • has a medical condition that would prevent consumption of most fruits and vegetables,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Risica PM, Gorham G, Dionne L, Nardi W, Ng D, Middler R, Mello J, Akpolat R, Gettens K, Gans KM. A multi-level intervention in worksites to increase fruit and vegetable access and intake: Rationale, design and methods of the 'Good to Go' cluster randomized trial. Contemp Clin Trials. 2018 Feb;65:87-98. doi: 10.1016/j.cct.2017.12.002. Epub 2017 Dec 12.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • KIM Gans

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator/Adjunct Professor

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 6, 2016

Study Start

September 1, 2010

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

April 6, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share