Clinical trial NCT02729675: Innovative Approaches to Increase F&V Intake Thru Worksites
Official title: Innovative Approaches to Increase F&V Intake Thru Worksites: The Fresh Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Food Habits
Eating Behavior
Keywords: fruit & vegetable, market, education, worksite, food access
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: University of Connecticut
First posted: 2016-04-06
Enrollment: 1804
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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,

Primary outcomes:
measure: Change in Fruit and Vegetable Intake
timeFrame: Baseline, 6 and 12 months
measure: Change in Fruit and Vegetable Intake
timeFrame: Baseline, 6 and 12 months
Secondary outcomes:
measure: Change in fruit and vegetable eating behaviors
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Brown University
name: KIM Gans
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.