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

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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

Tracking Information
First Submitted Date  ICMJE March 29, 2016
First Posted Date  ICMJE April 6, 2016
Last Update Posted Date April 6, 2016
Study Start Date  ICMJE September 2010
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
  • 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
  • Change in Fruit and Vegetable Intake [ Time Frame: Baseline, 6 and 12 months ]
    Two-Item Cup F&V intake screener
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
Change in fruit and vegetable eating behaviors [ Time Frame: Baseline, 6 and 12 months ]
F&V habits questions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Innovative Approaches to Increase F&V Intake Thru Worksites
Official Title  ICMJE Innovative Approaches to Increase F&V Intake Thru Worksites: The Fresh Initiative
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.
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  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Food Habits
  • Eating Behavior
Intervention  ICMJE
  • 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
  • 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
Study Arms
  • Experimental: Access Intervention
    Worksites in this condition received weekly Fruit and Vegetable markets
    Intervention: Other: Access 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
    Interventions:
    • Other: Access Intervention
    • Behavioral: Enhanced Intervention
  • Active Comparator: Comparison Intervention
    Worksites in this condition received Stress and Physical Activity Interventions
    Intervention: Behavioral: Comparison Behavioral Intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2016)
1804
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date December 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02729675
Other Study ID Numbers  ICMJE R01CA133396( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kim Gans, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE University of Connecticut
Investigators  ICMJE
Principal Investigator: KIM Gans Brown University
PRS Account Brown University
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP