Dietary HabitsPhase 2LWVBNCT02669472
Fresh to You: Multilevel Approaches in Low Income Housing to Increase F&V Intake
A Phase 2 study testing Environmental Intervention and Educational Intervention in people with Dietary Habits and Dietary Modification, run by Brown University.
Trial summary
Live Well, Viva Bien (LWVB) is an NCI-funded, cluster randomized controlled trial (RCT) that was conducted in 15 subsidized housing complexes to evaluate the efficacy of a multicomponent intervention comprised of a year-round, discount, mobile fresh F\&V market -'Fresh To You' (FTY)- that was paired with a nutrition… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Dietary Modification
- What is being tested?
- Environmental Intervention and Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,598 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jun 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
- Live in the Housing complex;
- Speak English or Spanish
- Ability to read study materials
Who cannot join
- Health issues that would not allow increases in fruit and vegetable intake
About this study
Live Well, Viva Bien (LWVB) is an NCI-funded, cluster randomized controlled trial (RCT) that was conducted in 15 subsidized housing complexes to evaluate the efficacy of a multicomponent intervention comprised of a year-round, discount, mobile fresh F\&V market -'Fresh To You' (FTY)- that was paired with a nutrition education component including included educational newsletters, campaigns, taste-testings and videos in both English and Spanish. The primary aim of the LWVB grant was to study the efficacy of FTY combined with a motivational/educational intervention to see if it increased F\&V consumption compared to a Comparison intervention (attention placebo).
Read the detailed description
'Live Well, Viva Bien' (LWVB) is a cluster randomized controlled trial in 15 subsidized housing complexes designed to evaluate the efficacy of a multicomponent intervention that includes discount, mobile fresh F\&V markets--'Fresh To You'(FTY) markets-in conjunction with a nutrition education intervention. The primary aims of this study are to: 1) Conduct formative research with residents living in subsidized housing projects to inform the multi-level intervention and; 2) Implement a group randomized trial to study the efficacy of the FTY markets combined with the educational/motivational interventions at increasing F\&V access, availability, and consumption compared to a Comparison intervention (attention placebo). Secondary aims are: 1) To include extensive implementation process evaluation to determine costs, reach, fidelity and dose and the relationship of these variables with evaluation outcomes; and to 2) Use a mediating variable framework to examine relationships among important psychosocial factors/determinants with changes in F\&V consumption.
All study activities occurred at housing sites in Providence County, Rhode Island. Pre-intervention focus groups were conducted with housing complex residents (from non-study sites) to inform intervention development. A total of 15 subsidized housing complexes were recruited into the evaluation cohort. One smaller housing complex served as a pilot site for the intervention group and the remaining 14 demographically-matched sites were randomized into either the intervention or control group. Adult residents from each housing site were recruited for the evaluation cohort prior to randomization. The multicomponent intervention lasted one year and included baseline, 6 and 12 month follow-up surveys as well as extensive quantitative and qualitative process evaluation throughout the course of the study. All study protocols were approved by the Brown University Institutional Review Board.
The intervention sites received regularly-scheduled, discount, fresh F\&V markets for one year. These FTY markets were not farmer's markets, but rather mobile markets selling both local and non-local produce on a year-round basis at prices at or below local supermarket prices. Intervention sites, markets received markets the first two weeks of each month. In addition, these Housing sites also received a motivational/educational intervention components over the course of the year including two campaigns (Just Add 2 and Color Your Plate), three, 20-minute DVDs, a two-page, full-color monthly newsletter , 48 Recipe cards, and cooking demonstrations at the housing sites.
The Comparison/Control Intervention sites received physical activity and stress reduction campaigns delivered by the Greater Providence YMCA.
Extensive process evaluation was conducted. Outcome measures included three different measures of F\&V intake. Data on potential mediators and moderators was also conducted.
- Conditions
- Dietary Habits, Dietary Modification
- Being tested
- Environmental Intervention, Educational Intervention, Control
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental InterventionOther
Also called Fresh To You fruit and vegetable markets
Intervention sites received regularly-scheduled, discount, fresh F\&V markets for one year during the first two weeks of each month. The markets brought between 50-70 different produce items, including culturally desired ethnic produce. Markets at the senior and disabled housing complexes were held indoors as were markets at family housing complexes during inclement weather. In good weather, markets were held outside at the family complexes using a mobile retrofitted car trailer. The produce items were set up in racks on three sides of the trailer and shoppers entered through the rear door. FTY markets accepted cash, debit/credit cards and EBT cards (SNAP). Each market lasted two hours and the produce was sold at prices 15%-25% lower than local retail supermarket prices.
Educational InterventionBehavioural
Also called Nutrition education interventions
Each household in the housing site received a reusable shopping bag that contained a binder with: an overview page, sleeves to store 12 newsletters, three DVDs and 48 recipe cards. The 20-minute DVDs included cooking demonstrations, tips and testimonials. A two-page, full-color newsletter was delivered each household each month. It had information about a particular F\&V in season as well as other tips and recipes. Two 6-week long educational and motivational campaigns were also offered: ''Just Add 2', and 'Color Your Plate'. Both campaigns included full-color campaign booklets, goal-setting activities, educational and motivational content, and F\&V trackers with incentives/prizes for completing and turning in the trackers. All materials were provided in English and Spanish.
ControlBehavioural
Also called Physical Activity and Stress Reduction campaigns
We contracted with the Greater Providence YMCA to bring to provide physical activity and stress reduction programming. Two, six-week campaigns followed the same format and timing of the intervention group campaigns. Campaigns participants received a free, 6-week membership to the YMCA. The 'Take 10!' campaign aimed to increase participants' daily physical activity by 10 minutes per day until they reached the goal of at least 30-60 minutes per day. The second campaign was 'Stress Less' aimed to help participants reduce the amount of stress that they experienced by including relaxation activity into their daily routine.
| Study group | Role | What they receive |
|---|---|---|
| F&V Intervention | Experimental | Housing complexes randomized to the intervention arm received a multicomponent intervention comprised of a year-round, discount, mobile fresh fruit and vegetable market ('Fresh To You') that was paired with nutrition education interventions including educational newsletters, recipe cards, campaigns, taste-testings and videos in both English and Spanish. Receives: Other: Environmental Intervention; Behavioral: Educational Intervention |
| Control Intervention | Experimental | Housing complexes randomized to the comparison arm received a year-long intervention on physical activity and stress reduction including educational campaigns and materials in both English and Spanish.and a YMCA membership for those who joined the campaigns. Receives: Behavioral: Control |
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 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 posted1 Feb 2016 (estimated)
- Study startApr 2009
- Primary completionOct 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dietary 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kim Gans, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669472
- Sponsor's protocol ID
- NCI
- Other IDs
- R01CA134903
- Acronym
- LWVB
- Status last verified
- Jan 2016
- First submitted
- 19 Jan 2016
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We will make aggregate data available to share.
Publications
Gans KM, Risica PM, Keita AD, Dionne L, Mello J, Stowers KC, Papandonatos G, Whittaker S, Gorham G. Multilevel approaches to increase fruit and vegetable intake in low-income housing communities: final results of the 'Live Well, Viva Bien' cluster-randomized trial. Int J Behav Nutr Phys Act. 2018 Aug 20;15(1):80. doi: 10.1186/s12966-018-0704-2.
PubMed 30126463Gans KM, Gorham G, Risica PM, Dulin-Keita A, Dionne L, Gao T, Peters S, Principato L. A multi-level intervention in subsidized housing sites to increase fruit and vegetable access and intake: Rationale, design and methods of the 'Live Well, Viva Bien' cluster randomized trial. BMC Public Health. 2016 Jun 28;16:521. doi: 10.1186/s12889-016-3141-7.
PubMed 27353149
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fresh to You: Multilevel Approaches in Low Income Housing to Increase F&V Intake
- ClinicalTrials.gov ID
- NCT02669472
- Acronym / sponsor ID
- LWVB / NCI
- Conditions
- Dietary Habits, Dietary Modification
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,598 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- University of Connecticut, National Cancer Institute (NCI)
- Study start
- Apr 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Feb 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.
Live Well, Viva Bien (LWVB) is an NCI-funded, cluster randomized controlled trial (RCT) that was conducted in 15 subsidized housing complexes to evaluate the efficacy of a multicomponent intervention comprised of a year-round, discount, mobile fresh F\&V market -'Fresh To You' (FTY)- that was paired with a nutrition education component including included educational newsletters, campaigns, taste-testings and videos in both English and Spanish. The primary aim of the LWVB grant was to study the efficacy of FTY combined with a motivational/educational intervention to see if it increased F\&V consumption compared to a Comparison intervention (attention placebo).
Detailed description
'Live Well, Viva Bien' (LWVB) is a cluster randomized controlled trial in 15 subsidized housing complexes designed to evaluate the efficacy of a multicomponent intervention that includes discount, mobile fresh F\&V markets--'Fresh To You'(FTY) markets-in conjunction with a nutrition education intervention. The primary aims of this study are to: 1) Conduct formative research with residents living in subsidized housing projects to inform the multi-level intervention and; 2) Implement a group randomized trial to study the efficacy of the FTY markets combined with the educational/motivational interventions at increasing F\&V access, availability, and consumption compared to a Comparison intervention (attention placebo). Secondary aims are: 1) To include extensive implementation process evaluation to determine costs, reach, fidelity and dose and the relationship of these variables with evaluation outcomes; and to 2) Use a mediating variable framework to examine relationships among important psychosocial factors/determinants with changes in F\&V consumption.
All study activities occurred at housing sites in Providence County, Rhode Island. Pre-intervention focus groups were conducted with housing complex residents (from non-study sites) to inform intervention development. A total of 15 subsidized housing complexes were recruited into the evaluation cohort. One smaller housing complex served as a pilot site for the intervention group and the remaining 14 demographically-matched sites were randomized into either the intervention or control group. Adult residents from each housing site were recruited for the evaluation cohort prior to randomization. The multicomponent intervention lasted one year and included baseline, 6 and 12 month follow-up surveys as well as extensive quantitative and qualitative process evaluation throughout the course of the study. All study protocols were approved by the Brown University Institutional Review Board.
The intervention sites received regularly-scheduled, discount, fresh F\&V markets for one year. These FTY markets were not farmer's markets, but rather mobile markets selling both local and non-local produce on a year-round basis at prices at or below local supermarket prices. Intervention sites, markets received markets the first two weeks of each month. In addition, these Housing sites also received a motivational/educational intervention components over the course of the year including two campaigns (Just Add 2 and Color Your Plate), three, 20-minute DVDs, a two-page, full-color monthly newsletter , 48 Recipe cards, and cooking demonstrations at the housing sites.
The Comparison/Control Intervention sites received physical activity and stress reduction campaigns delivered by the Greater Providence YMCA.
Extensive process evaluation was conducted. Outcome measures included three different measures of F\&V intake. Data on potential mediators and moderators was also conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F&V Intervention | Experimental | Other: Environmental Intervention, Behavioral: Educational InterventionHousing complexes randomized to the intervention arm received a multicomponent intervention comprised of a year-round, discount, mobile fresh fruit and vegetable market ('Fresh To You') that was paired with nutrition education interventions including educational newsletters, recipe cards, campaigns, taste-testings and videos in both English and Spanish. |
| Control Intervention | Experimental | Behavioral: ControlHousing complexes randomized to the comparison arm received a year-long intervention on physical activity and stress reduction including educational campaigns and materials in both English and Spanish.and a YMCA membership for those who joined the campaigns. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Live in the Housing complex;
- Speak English or Spanish
- Ability to read study materials
Key exclusion criteria (1 listed)
- Health issues that would not allow increases in fruit and vegetable intake
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 |
|---|---|---|
| Environmental InterventionAlso: Fresh To You fruit and vegetable marketsIntervention sites received regularly-scheduled, discount, fresh F\&V markets for one year during the first two weeks of each month. The markets brought between 50-70 different produce items, including culturally desired ethnic produce. Markets at the senior and disabled housing complexes were held indoors as were markets at family housing complexes during inclement weather. In good weather, markets were held outside at the family complexes using a mobile retrofitted car trailer. The produce items were set up in racks on three sides of the trailer and shoppers entered through the rear door. FTY markets accepted cash, debit/credit cards and EBT cards (SNAP). Each market lasted two hours and the produce was sold at prices 15%-25% lower than local retail supermarket prices. | Other | F&V Intervention |
| Educational InterventionAlso: Nutrition education interventionsEach household in the housing site received a reusable shopping bag that contained a binder with: an overview page, sleeves to store 12 newsletters, three DVDs and 48 recipe cards. The 20-minute DVDs included cooking demonstrations, tips and testimonials. A two-page, full-color newsletter was delivered each household each month. It had information about a particular F\&V in season as well as other tips and recipes. Two 6-week long educational and motivational campaigns were also offered: ''Just Add 2', and 'Color Your Plate'. Both campaigns included full-color campaign booklets, goal-setting activities, educational and motivational content, and F\&V trackers with incentives/prizes for completing and turning in the trackers. All materials were provided in English and Spanish. | Behavioural | F&V Intervention |
| ControlAlso: Physical Activity and Stress Reduction campaignsWe contracted with the Greater Providence YMCA to bring to provide physical activity and stress reduction programming. Two, six-week campaigns followed the same format and timing of the intervention group campaigns. Campaigns participants received a free, 6-week membership to the YMCA. The 'Take 10!' campaign aimed to increase participants' daily physical activity by 10 minutes per day until they reached the goal of at least 30-60 minutes per day. The second campaign was 'Stress Less' aimed to help participants reduce the amount of stress that they experienced by including relaxation activity into their daily routine. | Behavioural | Control 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 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 1 Feb 2016.
- Derived from this study: PubMed 30126463Gans KM, Risica PM, Keita AD, Dionne L, Mello J, Stowers KC, Papandonatos G, Whittaker S, Gorham G. Multilevel approaches to increase fruit and vegetable intake in low-income housing communities: final results of the 'Live Well, Viva Bien' cluster-randomized trial. Int J Behav Nutr Phys Act. 2018 Aug 20;15(1):80. doi: 10.1186/s12966-018-0704-2.
- Derived from this study: PubMed 27353149Gans KM, Gorham G, Risica PM, Dulin-Keita A, Dionne L, Gao T, Peters S, Principato L. A multi-level intervention in subsidized housing sites to increase fruit and vegetable access and intake: Rationale, design and methods of the 'Live Well, Viva Bien' cluster randomized trial. BMC Public Health. 2016 Jun 28;16:521. doi: 10.1186/s12889-016-3141-7.
- Individual participant dataSharing planned: No. We will make aggregate data available to share.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Environmental Intervention and Educational Intervention in people with Dietary Habits and Dietary Modification, 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 1 Feb 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 NCT02669472, which also lists 2 linked publications.
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 1 Feb 2016.