Food HabitsPhase 2Good to GoNCT02729675
Innovative Approaches to Increase F&V Intake Thru Worksites
A Phase 2 study testing Access Intervention, Enhanced Intervention and Comparison Behavioral Intervention in people with Food Habits and Eating Behavior, run by Brown University.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Habits, Eating Behavior
- What is being tested?
- Access Intervention, Enhanced Intervention and Comparison Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,804 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- has a medical condition that would prevent consumption of most fruits and vegetables,
About this study
Official title: Innovative Approaches to Increase F&V Intake Thru Worksites: The Fresh Initiative
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.
Read the 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.
- Conditions
- Food Habits, Eating Behavior
- Being tested
- Access Intervention, Enhanced Intervention, Comparison Behavioral Intervention
- Keywords
- fruit & vegetable, market, education, worksite, food access
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access InterventionOther
Also called Fresh to You Fruit and Vegetable Mobile Market 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.
Enhanced InterventionBehavioural
Also called Educational plus Access 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 InterventionBehavioural
Also called Attention Placebo Control
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.
| Study group | Role | What they receive |
|---|---|---|
| Access Intervention | Experimental | Worksites in this condition received weekly Fruit and Vegetable markets Receives: Other: Access Intervention |
| Enhanced Intervention | Experimental | Worksites in this condition received weekly Fruit and Vegetable markets and Educational Interventions including Campaigns, Newsletters, DVDs, A Website, and Chef Demonstrations Receives: Other: Access Intervention; Behavioral: Enhanced Intervention |
| Comparison Intervention | Active comparator | Worksites in this condition received Stress and Physical Activity Interventions Receives: Behavioral: Comparison Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fruit and Vegetable Intake
Measured by National Cancer Institute Eating at America's Table All Day Screener
Measured: Baseline, 6 and 12 months
Change in Fruit and Vegetable Intake
Two-Item Cup F\&V intake screener
Measured: Baseline, 6 and 12 months
Secondary outcomes (1)
Change in fruit and vegetable eating behaviors
F\&V habits questions
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startSep 2010
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food HabitsStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut
- Responsible party
- Principal investigator, Kim Gans, Brown University
- Investigators
- KIM Gans, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729675
- Sponsor's protocol ID
- R01CA133396
- Acronym
- Good to Go
- Status last verified
- Mar 2016
- First submitted
- 29 Mar 2016
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 29242108
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Approaches to Increase F&V Intake Thru Worksites: The Fresh Initiative
- ClinicalTrials.gov ID
- NCT02729675
- Acronym / sponsor ID
- Good to Go / R01CA133396
- Conditions
- Food Habits, Eating Behavior
- Keywords
- fruit & vegetable, market, education, worksite, food access
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,804 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- University of Connecticut
- Study start
- Sep 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Access Intervention | Experimental | Other: Access InterventionWorksites in this condition received weekly Fruit and Vegetable markets |
| Enhanced Intervention | Experimental | Other: Access Intervention, Behavioral: Enhanced InterventionWorksites in this condition received weekly Fruit and Vegetable markets and Educational Interventions including Campaigns, Newsletters, DVDs, A Website, and Chef Demonstrations |
| Comparison Intervention | Active comparator | Behavioral: Comparison Behavioral InterventionWorksites in this condition received Stress and Physical Activity Interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- has a medical condition that would prevent consumption of most fruits and vegetables,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access InterventionAlso: Fresh to You Fruit and Vegetable Mobile Market InterventionThe 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 | Access Intervention, Enhanced Intervention |
| Enhanced InterventionAlso: Educational plus Access InterventionThe 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. | Behavioural | Enhanced Intervention |
| Comparison Behavioral InterventionAlso: Attention Placebo ControlBrown 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. | Behavioural | Comparison Intervention |
Primary outcome
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
1 secondary outcome
Change in fruit and vegetable eating behaviors
Time frame: Baseline, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Derived from this study: PubMed 29242108Risica 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KIM Gans principal investigator
Brown University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Access Intervention, Enhanced Intervention and Comparison Behavioral Intervention in people with Food Habits and Eating Behavior, run by Brown University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fruit and Vegetable Intake (time frame: Baseline, 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02729675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.