Fruit and Vegetable Vouchers With and Without an SSB Tax

NCT03567967 | Completed DMC

• 1 other identifier: 43831
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Cardiovascular Diseases

Keywords

nutrition; fruits and vegetables; sugar-sweetened beverages

Outcome Measures

Primary Outcomes (1)

• Change in fruit and vegetable consumption

  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).

  Month 0 to Month 6

Secondary Outcomes (5)

• Change in nutrition quality per HEI score

  Month 0 to Month 6

• Change in nutrition quality per AHEI score

  Month 0 to Month 6

• Change in SSB consumption

  Month 0 to Month 6

• Change in overall caloric intake

  Month 0 to Month 6

• Overall percentage of vouchers redeemed

  Month 0 to Month 6

Study Arms (2)

San Francisco

EXPERIMENTAL

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.

Behavioral: Fruit and vegetable voucher

Los Angeles

ACTIVE COMPARATOR

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.

Behavioral: Fruit and vegetable voucher

Interventions

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.

Also known as: Voucher

Los Angeles; San Francisco

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• University of California, San Francisco: collaborator

Study Sites (2)

University of California

San Francisco, California, 94158, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Related Links

• San Francisco program
• Los Angeles program

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Fruit

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sanjay Basu, MD, PhD

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

• Dean Schillinger, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 24-hour dietary recalls are conducted by blinded registered dietitians
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 26, 2018
• Study Start: May 31, 2018
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)