Innovative Approaches to Increase F&V Intake Thru Worksites

Eating Behavior Clinical Trial

— Good to Go  

Official title:

Innovative Approaches to Increase F&V Intake Thru Worksites: The Fresh Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729675
• Other study ID #: R01CA133396
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2016
• Last updated: March 31, 2016
• Start date: September 2010
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1804
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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,

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Eating Behavior
• Food Habits

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	University of Connecticut

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fruit and Vegetable Intake	Measured by National Cancer Institute Eating at America's Table All Day Screener	Baseline, 6 and 12 months	No
Primary	Change in Fruit and Vegetable Intake	Two-Item Cup F&V intake screener	Baseline, 6 and 12 months	No
Secondary	Change in fruit and vegetable eating behaviors	F&V habits questions	Baseline, 6 and 12 months	No