NCT02843178

Brief Summary

Improving diets through increased food and vegetable (F\&V) consumption significantly reduces the risk of cardiovascular disease (CVD). Programs increasing the accessibility and affordability of F\&Vs among low-income Americans have been hindered by the food consumption cycle associated with poverty: the tendency to over-consume calories shortly after receiving funds at the beginning of each month, draining the budget for F\&V purchases, or for all food purchases, by month's end. An emerging theory about dietary behavior suggests that providing funds for food in smaller installments distributed throughout the month will smooth the consumption cycle and improve healthy eating-counteracting the tendency to respond to lump sum, once-monthly funding installments by purchasing calorie-dense foods immediately after funds are received. The theory also suggests that funds targeted toward specific healthy foods (e.g., F\&Vs) will improve diets more than untargeted funds, despite the inconvenience of utilizing targeted funds. We will rigorously test both hypotheses in a real-world setting by comparing alternative approaches for delivering food purchasing vouchers. We have established and tested the infrastructure to provide vouchers accepted by numerous food sellers (e.g., supermarkets, corner shops) in low-income neighborhoods. Leveraging this infrastructure, we will conduct a randomized trial with a two-by-two factorial design, comparing $20 of vouchers valid for one month to four $5 vouchers each valid for a sequential week of the month (lump sum versus distributed funding), and comparing vouchers restricted to F\&V purchases to vouchers redeemable for any food (targeted versus untargeted funding). Low-income adults (N=288) recruited through our community partners will be randomized to one of four 6-month interventions: monthly targeted, monthly untargeted, weekly targeted, or weekly untargeted vouchers. Participants will be assessed through efficient verbal 24-hour dietary recalls validated among low-literacy populations, to determine daily consumption of F\&Vs and metrics of overall dietary quality at months 0, 6 and 12 (6 months after vouchers end). Additional surveys will identify moderators and mediators of dietary improvement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
359

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

July 20, 2016

Results QC Date

December 14, 2018

Last Update Submit

July 24, 2019

Conditions

Keywords

nutritionfood securitybehavioral economics

Outcome Measures

Primary Outcomes (1)

  • Change in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 6

    Fruit and vegetable intake (measured in Cup-equivalents) at the end of month 6 of the trial, assessed by 24-hour dietary recall

    Baseline and Month 6

Secondary Outcomes (3)

  • Change in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 12

    Baseline and Month 12

  • Change in Healthy Eating Index From Baseline to Month 6

    Baseline and Month 6

  • Voucher Utilization Rate

    Months 1-6 of intervention

Other Outcomes (4)

  • Voucher Ease of Use Survey

    Month 6

  • Self-reported Height Survey

    Month 6

  • Food Security Survey

    Baseline, Month 6, and Month 12

  • +1 more other outcomes

Study Arms (4)

1: distributed, targeted vouchers

EXPERIMENTAL

Participants receive four $5 vouchers each valid for a subsequent week of the month (i.e., one voucher valid for week 1 only, a second for week 2 only, a third for week 3 only, and a fourth for week 4 only), starting in month 1 and continuing every month through month 6. The voucher is restricted to pay for fruits and vegetables.

Behavioral: Vouchers

2: lump sum, targeted vouchers

ACTIVE COMPARATOR

Participants receive four $5 vouchers each valid for an entire month, starting in month 1 and continuing every month through month 6. The voucher is restricted to pay for fruits and vegetables.

Behavioral: Vouchers

3: distributed, untargeted vouchers

ACTIVE COMPARATOR

Participants receive four $5 vouchers each valid for a subsequent week of the month (i.e., one voucher valid for week 1 only, a second for week 2 only, a third for week 3 only, and a fourth for week 4 only), starting in month 1 and continuing every month through month 6. The voucher can pay for any food but not tobacco, alcohol or prepared foods.

Behavioral: Vouchers

4: lump sum, untargeted vouchers

ACTIVE COMPARATOR

Participants receive four $5 vouchers each valid for an entire month, starting in month 1 and continuing every month through month 6. The voucher can pay for any food but not tobacco, alcohol or prepared foods.

Behavioral: Vouchers

Interventions

VouchersBEHAVIORAL

A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill.

1: distributed, targeted vouchers2: lump sum, targeted vouchers3: distributed, untargeted vouchers4: lump sum, untargeted vouchers

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHIVES Study Office

San Francisco, California, 94124, United States

Location

Related Publications (4)

  • White JS, Basu S. Does the benefits schedule of cash assistance programs affect the purchase of temptation goods? Evidence from Peru. J Health Econ. 2016 Mar;46:70-89. doi: 10.1016/j.jhealeco.2016.01.005. Epub 2016 Jan 29.

    PMID: 26874596BACKGROUND
  • Whittle HJ, Palar K, Hufstedler LL, Seligman HK, Frongillo EA, Weiser SD. Food insecurity, chronic illness, and gentrification in the San Francisco Bay Area: An example of structural violence in United States public policy. Soc Sci Med. 2015 Oct;143:154-61. doi: 10.1016/j.socscimed.2015.08.027. Epub 2015 Aug 20.

    PMID: 26356827BACKGROUND
  • Seligman HK, Bolger AF, Guzman D, Lopez A, Bibbins-Domingo K. Exhaustion of food budgets at month's end and hospital admissions for hypoglycemia. Health Aff (Millwood). 2014 Jan;33(1):116-23. doi: 10.1377/hlthaff.2013.0096.

    PMID: 24395943BACKGROUND
  • Basu S, Gardner CD, White JS, Rigdon J, Carroll MM, Akers M, Seligman HK. Effects Of Alternative Food Voucher Delivery Strategies On Nutrition Among Low-Income Adults. Health Aff (Millwood). 2019 Apr;38(4):577-584. doi: 10.1377/hlthaff.2018.05405.

MeSH Terms

Conditions

Cardiovascular Diseases

Limitations and Caveats

Dietary data are from self-report, via 24-hour dietary recalls. Survey data are from self-reported scales.

Results Point of Contact

Title
Mandy Murphy Carroll, Study Coordinator
Organization
Stanford University

Study Officials

  • Sanjay Basu, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Hilary K Seligman, MD, MS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Christopher D Gardner, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 25, 2016

Study Start

December 1, 2016

Primary Completion

October 9, 2018

Study Completion

October 9, 2018

Last Updated

August 28, 2019

Results First Posted

August 28, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations