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Fruit and Vegetable Vouchers With and Without an SSB Tax (EVIDENCE)

15. juli 2020 oppdatert av: Christopher Gardner, Stanford University

The EValuating Interventions in Diabetogenic Environments Through Natural Controlled Experiments (EVIDENCE) Trial

We aim to examine whether a purchasing incentive for healthy foods has the same effect on dietary intake in a community with and a community without a purchasing penalty for unhealthy foods. We will perform a randomized non-inferiority trial in two locations, San Francisco (SF) and Los Angeles (LA) to test whether a voucher for purchasing fresh fruits and vegetables has a similar effect in LA and in SF, where the former does not but the latter does have a tax on sugar-sweetened beverages. Participants will be recruited from 4 neighborhoods (N=312) with 2 SF neighborhoods (exposed to the SSB tax) and 2 LA neighborhoods (not exposed to the SSB tax).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

We will test the hypothesis that a positive incentive for healthy foods (fresh fruits and vegetables, F&Vs) will be utilized as effectively in a community without a purchasing penalty for unhealthy foods (a sugar-sweetened beverage [SSB] tax) as in a community with a purchasing penalty for unhealthy foods (a SSB tax). Our experiment will test the empirically-driven hypothesis in a real-world setting through a noninferiority design: comparing the impact of F&V vouchers in two counties, one without (Los Angeles) and one with (San Francisco) a SSB tax.

Each study participant will receive four paper vouchers per month for a total of six months. Each of these vouchers can be redeemed for fresh or frozen fruits and vegetables at a number of specified local corner stores, supermarkets, or farmer's markets.

Half of these participants will receive and spend these vouchers in an environment which has implemented a SSB tax (SF); the other half will receive and spend these same vouchers in a non-tax environment (LA).

Each individual participant will be enrolled in the study for a total of seven months from initial orientation and participant consent (M0) to final data collection during final month of intervention (M6).

We are using a non-inferiority trial design. We are aiming to test whether there is a significant difference in total cup-equivalents of F&V intake in LA participants as compared to SF participants when given F&V vouchers. That is, we aim to test whether the F&V voucher is less effective in LA than in SF. This is important to test because it has been purported that SF has a unique food environment with high accessibility to fresh F&V through farmer's markets and a plethora of corner stores, as well as a SSB tax that discourages less healthy foods, potentially leaving more funds for healthier F&Vs. Thus, we aim to determine the change in consumption of F&V in LA participants is non-inferiority to that of SF participants, when both are given F&V vouchers.

Studietype

Intervensjonell

Registrering (Faktiske)

313

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • San Francisco, California, Forente stater, 94158
        • University of California
      • Stanford, California, Forente stater, 94305
        • Stanford University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Understand English sufficiently to provide informed consent;
  2. Provision of signed and dated informed consent form;
  3. Stated willingness to comply with all study procedures and availability for the duration of the study;
  4. Any gender, aged 21 years or older;
  5. Have self-reported income ≤250% of the federal poverty level;
  6. Have regular access to a mobile phone;
  7. Have a safe and secure mailing address at which to receive vouchers;
  8. Be a resident of the Counties of San Francisco or Los Angeles as defined by official municipal boundaries.

Exclusion Criteria:

  1. Currently participating in any other dietary or nutrition study that would impact his or her normal eating patterns;
  2. Currently be enrolled in and receiving EatSF, CHIVES, or Vouchers4Veggies vouchers;
  3. Has active diagnosis of cancer or congestive heart failure;
  4. Is planning to move out of San Francisco or Los Angeles in the next 12 months;
  5. Currently pregnant.
  6. Currently live with and share a food budget with a current Vouchers4Veggies, EVIDENCE, or CHIVES study participant.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: San Francisco
Each study participant will receive four paper vouchers per month for a total of six months. Each of these vouchers can be redeemed for fresh or frozen fruits and vegetables at a number of specified local corner stores, supermarkets, or farmer's markets. The San Francisco participants will receive and spend these vouchers in an environment which has implemented a sugar-sweetened beverage tax.
Atferdsmessig: Fruit and vegetable voucher
Participants will receive four vouchers, each dated for a month, to be used on fruits and vegetables at specified local corner stores, supermarkets, and farmer's markets for a duration of six months. Each study participant will have the same intervention, as this is a non-inferiority trial to compare voucher use in LA and test whether the nutritional effects of that use are non-inferior to use in SF.
Andre navn:
  • Voucher
Aktiv komparator: Los Angeles
Each study participant will receive four paper vouchers per month for a total of six months. Each of these vouchers can be redeemed for fresh or frozen fruits and vegetables at a number of specified local corner stores, supermarkets, or farmer's markets. The Los Angeles participants will receive and spend these vouchers in an environment which has NOT implemented a sugar-sweetened beverage tax.
Atferdsmessig: Fruit and vegetable voucher
Participants will receive four vouchers, each dated for a month, to be used on fruits and vegetables at specified local corner stores, supermarkets, and farmer's markets for a duration of six months. Each study participant will have the same intervention, as this is a non-inferiority trial to compare voucher use in LA and test whether the nutritional effects of that use are non-inferior to use in SF.
Andre navn:
  • Voucher

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in fruit and vegetable consumption
Tidsramme: Month 0 to Month 6
Change in fruit and vegetable consumption from baseline (BL), i.e., before voucher receipt, to the end of the intervention at the end of month 6 (M6), i.e., during the final month of voucher receipt, measured by two 24-hour recalls at each data collection point (BL and M6).
Month 0 to Month 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in nutrition quality per HEI score
Tidsramme: Month 0 to Month 6
Change in nutrition quality of study participants from BL to M6, measured by the Healthy Eating Index (HEI), which is calculated from two 24-hour recalls at each data collection point (BL and M6).
Month 0 to Month 6
Change in nutrition quality per AHEI score
Tidsramme: Month 0 to Month 6
Change in nutrition quality of study participants from BL to M6, measured by the Alternative Healthy Eating Index (AHEI), which is calculated from two 24-hour recalls at each data collection point (BL and M6).
Month 0 to Month 6
Change in SSB consumption
Tidsramme: Month 0 to Month 6
Change in SSB consumption from BL to M6, measured in change in fluid ounces, as measured by two 24-hour recalls at each data collection point (BL and M6).
Month 0 to Month 6
Change in overall caloric intake
Tidsramme: Month 0 to Month 6
Change in overall caloric intake from BL to M6, measured in change in kcal, as measured by two 24-hour dietary recalls at each data collection point (BL and M6).
Month 0 to Month 6
Overall percentage of vouchers redeemed
Tidsramme: Month 0 to Month 6
Overall percentage of vouchers redeemed per participant, measured by how many vouchers each participant redeemed as compared to how many vouchers they received over the 6 month intervention period.
Month 0 to Month 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Stanford University

Samarbeidspartnere

University of California, San Francisco

Etterforskere

  • Hovedetterforsker: Dean Schillinger, MD, University of California, San Francisco
  • Hovedetterforsker: Sanjay Basu, MD, PhD, Assistant Professor of Medicine

Publikasjoner og nyttige lenker

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Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. mai 2018

Primær fullføring (Faktiske)

9. september 2019

Studiet fullført (Faktiske)

9. september 2019

Datoer for studieregistrering

Først innsendt

31. mai 2018

Først innsendt som oppfylte QC-kriteriene

21. juni 2018

Først lagt ut (Faktiske)

26. juni 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juli 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juli 2020

Sist bekreftet

1. juli 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 43831

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

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Nei

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