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

15 luglio 2020 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

313

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • San Francisco, California, Stati Uniti, 94158
        • University of California
      • Stanford, California, Stati Uniti, 94305
        • Stanford University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Altri nomi:
  • Voucher
Comparatore attivo: 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.
Comportamentale: 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.
Altri nomi:
  • Voucher

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in fruit and vegetable consumption
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in nutrition quality per HEI score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Stanford University

Collaboratori

University of California, San Francisco

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

31 maggio 2018

Completamento primario (Effettivo)

9 settembre 2019

Completamento dello studio (Effettivo)

9 settembre 2019

Date di iscrizione allo studio

Primo inviato

31 maggio 2018

Primo inviato che soddisfa i criteri di controllo qualità

21 giugno 2018

Primo Inserito (Effettivo)

26 giugno 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 luglio 2020

Ultimo verificato

1 luglio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 43831

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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