Fresh to You: Multilevel Approaches in Low Income Housing to Increase F&V Intake — LWVB  

Dietary Habits Clinical Trial

Official title: Fresh to You: Multilevel Approaches in Low Income Housing to Increase F&V Intake

Status Completed

Clinical 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 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).

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dietary Habits
• Dietary Modification

• NCT number: NCT02669472
• Study type: Interventional
• Source: Brown University
• Status: Completed
• Phase: Phase 2
• Start date: April 2009
• Completion date: June 2015