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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.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
Yes
University of California
San Francisco, California, United States
Stanford University
Stanford, California, United States
Start Date
May 31, 2018
Primary Completion Date
September 9, 2019
Completion Date
September 9, 2019
Last Updated
July 17, 2020
313
ACTUAL participants
Fruit and vegetable voucher
BEHAVIORAL
Lead Sponsor
Stanford University
Collaborators
NCT06909773
NCT06505109
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06189313