Fruit and Vegetable Vouchers With and Without an SSB Tax

NCT ID: NCT03567967

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2019-09-09

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
24-hour dietary recalls are conducted by blinded registered dietitians

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Fruit and vegetable voucher

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Fruit and vegetable voucher

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Voucher

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Christopher Gardner

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanjay Basu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Medicine

Dean Schillinger, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California

San Francisco, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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43831

Identifier Type: -

Identifier Source: org_study_id

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