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

27 januari 2016 bijgewerkt door: Kim Gans, Brown University
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).

Studie Overzicht

Gedetailleerde beschrijving

'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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1598

Fase

  • Fase 2

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: F&V Intervention
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.
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.
Andere namen:
  • Fresh To You fruit and vegetable markets
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.
Andere namen:
  • Nutrition education interventions
Experimenteel: Control Intervention
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.
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.
Andere namen:
  • Physical Activity and Stress Reduction campaigns

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Fruit and Vegetable Intake
Tijdsspanne: Baseline, 6 and 12 months
Measured by National Cancer Institute Eating at America's Table All Day Screener
Baseline, 6 and 12 months
Change in Fruit and Vegetable Intake
Tijdsspanne: Baseline, 6 and 12 months
Two-Item Cup F&V intake screener
Baseline, 6 and 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in fruit and vegetable behaviors
Tijdsspanne: Baseline, 6 and 12 months
F&V habits questions
Baseline, 6 and 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

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Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2009

Primaire voltooiing (Werkelijk)

1 oktober 2014

Studie voltooiing (Werkelijk)

1 juni 2015

Studieregistratiedata

Eerst ingediend

19 januari 2016

Eerst ingediend dat voldeed aan de QC-criteria

27 januari 2016

Eerst geplaatst (Schatting)

1 februari 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

1 februari 2016

Laatste update ingediend die voldeed aan QC-criteria

27 januari 2016

Laatst geverifieerd

1 januari 2016

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • NCI (HHSN261200700046C)
  • R01CA134903 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

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NEE

Beschrijving IPD-plan

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