NCT02669472

Brief 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 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,598

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

5.5 years

First QC Date

January 19, 2016

Last Update Submit

January 27, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Fruit and Vegetable Intake

    Measured by National Cancer Institute Eating at America's Table All Day Screener

    Baseline, 6 and 12 months

  • Change in Fruit and Vegetable Intake

    Two-Item Cup F\&V intake screener

    Baseline, 6 and 12 months

Secondary Outcomes (1)

  • Change in fruit and vegetable behaviors

    Baseline, 6 and 12 months

Study Arms (2)

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.

Other: Environmental InterventionBehavioral: 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.

Behavioral: Control

Interventions

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.

Also known as: Fresh To You fruit and vegetable markets
F&V Intervention

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.

Also known as: Nutrition education interventions
F&V Intervention
ControlBEHAVIORAL

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.

Also known as: Physical Activity and Stress Reduction campaigns
Control Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Live in the Housing complex;
  • Speak English or Spanish
  • Ability to read study materials

You may not qualify if:

  • Health issues that would not allow increases in fruit and vegetable intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • Gans 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.

MeSH Terms

Conditions

Feeding Behavior

Interventions

Milieu TherapyEarly Intervention, EducationalExercise

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesChild Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator/Adjunct Professor

Study Record Dates

First Submitted

January 19, 2016

First Posted

February 1, 2016

Study Start

April 1, 2009

Primary Completion

October 1, 2014

Study Completion

June 1, 2015

Last Updated

February 1, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

We will make aggregate data available to share.