Cardiovascular Diseases Clinical Trial
Official title:
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).
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.
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