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OpenTrials
Completed

NCT Number: NCT03567967

Fruit and Vegetable Vouchers With and Without an SSB Tax

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).

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fruit and vegetable voucher

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.

Other names: Voucher

Primary outcomes

  1. Change in fruit and vegetable consumption

    Time frame: 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).

Secondary outcomes

  1. Change in nutrition quality per HEI score

    Time frame: 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).

  2. Change in nutrition quality per AHEI score

    Time frame: 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).

  3. Change in SSB consumption

    Time frame: 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).

  4. Change in overall caloric intake

    Time frame: 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).

  5. Overall percentage of vouchers redeemed

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • University of California, San Francisco

Registry information

Official study title

The EValuating Interventions in Diabetogenic Environments Through Natural Controlled Experiments (EVIDENCE) Trial

Acronym: EVIDENCE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2018
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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