Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Innovative Approaches to Increase F&V Intake Thru Worksites (Good to Go)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02729675
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
University of Connecticut
Information provided by (Responsible Party):
Kim Gans, Brown University

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.

Condition or disease Intervention/treatment Phase
Food Habits Eating Behavior Other: Access Intervention Behavioral: Enhanced Intervention Behavioral: Comparison Behavioral Intervention Phase 2

Detailed Description:

"Good to Go" (GTG) is a cluster randomized trial, which is studying the efficacy of innovative multi-level worksite interventions including educational/behavioral interventions and/or a fruit and vegetable (F&V) market at the worksite to improve F&V intake of employees. The hypothesis is that providing convenient, inexpensive access to F&V at the workplace through a F&V market will increase the availability of F&V at the workplace as well as at home and increase F&V intake of the employee. However, because it is unclear if improving F&V access and availability alone is adequate to increase F&V intake, the investigators will test the efficacy of the F&V delivery intervention alone and in combination with a promotional/educational intervention delivered at the worksite. The efficacy of these innovative interventions will be tested during a cluster randomized trial with 21 worksites to determine which interventions are most efficacious in increasing F&V consumption.

The primary specific aims of this proposed research are to employ a cluster randomized trial to study the efficacy of delivering fresh F&V at reduced prices for purchase at worksites (access intervention); the F&V delivery intervention paired with educational interventions to change informational and social environments at the worksite (enhanced intervention); and a comparison intervention acting as an attention placebo. The study will compare the efficacy of the Access intervention and the enhanced intervention with the comparison Arm and will also compare the efficacy of the Access intervention to the Enhanced intervention.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1804 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Innovative Approaches to Increase F&V Intake Thru Worksites: The Fresh Initiative
Study Start Date : September 2010
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Access Intervention
Worksites in this condition received weekly Fruit and Vegetable markets
Other: Access Intervention
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.
Other Name: Fresh to You Fruit and Vegetable Mobile Market Intervention

Experimental: Enhanced Intervention
Worksites in this condition received weekly Fruit and Vegetable markets and Educational Interventions including Campaigns, Newsletters, DVDs, A Website, and Chef Demonstrations
Other: Access Intervention
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.
Other Name: Fresh to You Fruit and Vegetable Mobile Market Intervention

Behavioral: Enhanced 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.
Other Name: Educational plus Access Intervention

Active Comparator: Comparison Intervention
Worksites in this condition received Stress and Physical Activity Interventions
Behavioral: Comparison Behavioral 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.
Other Name: Attention Placebo Control




Primary Outcome Measures :
  1. Change in Fruit and Vegetable Intake [ Time Frame: Baseline, 6 and 12 months ]
    Measured by National Cancer Institute Eating at America's Table All Day Screener

  2. Change in Fruit and Vegetable Intake [ Time Frame: Baseline, 6 and 12 months ]
    Two-Item Cup F&V intake screener


Secondary Outcome Measures :
  1. Change in fruit and vegetable eating behaviors [ Time Frame: Baseline, 6 and 12 months ]
    F&V habits questions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729675


Sponsors and Collaborators
Brown University
University of Connecticut
Investigators
Layout table for investigator information
Principal Investigator: KIM Gans Brown University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kim Gans, Principal Investigator/Adjunct Professor, Brown University
ClinicalTrials.gov Identifier: NCT02729675     History of Changes
Other Study ID Numbers: R01CA133396 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kim Gans, Brown University:
fruit & vegetable, market, education, worksite, food access