Fruit and Vegetable Vouchers With and Without an SSB Tax (EVIDENCE)
The EValuating Interventions in Diabetogenic Environments Through Natural Controlled Experiments (EVIDENCE) Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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California
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San Francisco, California, Stany Zjednoczone, 94158
- University of California
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Stanford, California, Stany Zjednoczone, 94305
- Stanford University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Understand English sufficiently to provide informed consent;
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Any gender, aged 21 years or older;
- Have self-reported income ≤250% of the federal poverty level;
- Have regular access to a mobile phone;
- Have a safe and secure mailing address at which to receive vouchers;
- Be a resident of the Counties of San Francisco or Los Angeles as defined by official municipal boundaries.
Exclusion Criteria:
- Currently participating in any other dietary or nutrition study that would impact his or her normal eating patterns;
- Currently be enrolled in and receiving EatSF, CHIVES, or Vouchers4Veggies vouchers;
- Has active diagnosis of cancer or congestive heart failure;
- Is planning to move out of San Francisco or Los Angeles in the next 12 months;
- Currently pregnant.
- Currently live with and share a food budget with a current Vouchers4Veggies, EVIDENCE, or CHIVES study participant.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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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.
Inne nazwy:
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Aktywny 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.
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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.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in fruit and vegetable consumption
Ramy czasowe: Month 0 to Month 6
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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).
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Month 0 to Month 6
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in nutrition quality per HEI score
Ramy czasowe: Month 0 to Month 6
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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).
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Month 0 to Month 6
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Change in nutrition quality per AHEI score
Ramy czasowe: Month 0 to Month 6
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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).
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Month 0 to Month 6
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Change in SSB consumption
Ramy czasowe: Month 0 to Month 6
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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).
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Month 0 to Month 6
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Change in overall caloric intake
Ramy czasowe: Month 0 to Month 6
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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).
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Month 0 to Month 6
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Overall percentage of vouchers redeemed
Ramy czasowe: Month 0 to Month 6
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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.
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Month 0 to Month 6
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Dean Schillinger, MD, University of California, San Francisco
- Główny śledczy: Sanjay Basu, MD, PhD, Assistant Professor of Medicine
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 43831
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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