- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02729675
Innovative Approaches to Increase F&V Intake Thru Worksites (Good to Go)
Innovative Approaches to Increase F&V Intake Thru Worksites: The Fresh Initiative
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Access Intervention
Worksites in this condition received weekly Fruit and Vegetable markets
|
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 Names:
|
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
|
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 Names:
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 Names:
|
Active Comparator: Comparison Intervention
Worksites in this condition received Stress and Physical Activity Interventions
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 6 and 12 months
|
Change in Fruit and Vegetable Intake
Time Frame: Baseline, 6 and 12 months
|
Two-Item Cup F&V intake screener
|
Baseline, 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fruit and vegetable eating behaviors
Time Frame: Baseline, 6 and 12 months
|
F&V habits questions
|
Baseline, 6 and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: KIM Gans, Brown University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01CA133396 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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