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Designing Food Voucher Programs to Reduce Disparities in Healthy Diets (CHIVES)

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ClinicalTrials.gov Identifier: NCT02843178
Recruitment Status : Completed
First Posted : July 25, 2016
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
University of California, San Francisco
University of California, Irvine
Information provided by (Responsible Party):
Christopher Gardner, Stanford University

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Vouchers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 359 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Coupons for Healthy Intake Using Variable Economic Strategies (CHIVES)
Study Start Date : December 2016
Actual Primary Completion Date : October 9, 2018
Actual Study Completion Date : October 9, 2018

Arm Intervention/treatment
Experimental: 1: distributed, targeted vouchers
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
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.

Active Comparator: 2: lump sum, targeted vouchers
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
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.

Active Comparator: 3: distributed, untargeted vouchers
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
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.

Active Comparator: 4: lump sum, untargeted vouchers
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
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.




Primary Outcome Measures :
  1. Change in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 6 [ Time Frame: Baseline and 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


Secondary Outcome Measures :
  1. Change in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ]
    Fruit and vegetable intake (measured in Cup-equivalents) at the end of month 12 of the trial (6 months after voucher program has ended), assessed by 24-hour dietary recall.

  2. Change in Healthy Eating Index From Baseline to Month 6 [ Time Frame: Baseline and Month 6 ]
    Healthy Eating Index (a composite metric of nutrition quality) estimated from 24-hour dietary recall. The scores range from 0 to 100. An ideal overall Healthy Eating Index score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans (DGA).

  3. Voucher Utilization Rate [ Time Frame: Months 1-6 of intervention ]
    Percent of vouchers utilized by participants in each study arm


Other Outcome Measures:
  1. Voucher Ease of Use Survey [ Time Frame: Month 6 ]
    Survey of how easy participants found it to use vouchers. This is a composite score ranging from 0 (hard) to 3 (easy) based on individual scores of 0 (hard) or 1 (easy) in response to three questions at month 6 (the questions are in the appendix), which assessed participants' understanding of how to use the vouchers, ability to determine which foods were redeemable, and ease of redeeming the voucher with a cashier.

  2. Self-reported Height Survey [ Time Frame: Month 6 ]
    Self-reported height by phone survey.

  3. Food Security Survey [ Time Frame: Baseline, Month 6, and Month 12 ]
    This is the 6-item United States Department of Agriculture food security scale; the survey questions are in the appendix under "Main Survey." Each of the responses to the 6 questions were scored as a 1 or 0, depending of the particular question. The individual scores were then totaled, and individuals could receive a score anywhere from 0 indicating the most food security to 6 indicating the least food security. Then, the totaled individual 0 to 6 scores (fs_total) were broken into two categories, 0-1 being food secure, and 2-6 being food insecure. The number of participants below reflects the total number of participants who were food secure (that is, scored fs_total = 0-1) at Baseline, Month 6, and Month 12, respectively.

  4. Self-reported Weight Survey [ Time Frame: Month 6 ]
    Self-reported weight by phone survey.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Inclusion Criteria: age ≥21 years; household income <250% of the federal poverty level; has regular access to a phone; understands English sufficiently to provide informed consent; a resident of the City of San Francisco as defined by official municipal boundaries; willing to be randomized. Exclusion Criteria: participating in a diet including any other dietary or nutrition study; currently has diagnosed cancer or congestive heart failure; is pregnant; planning to move in the next year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843178


Locations
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United States, California
CHIVES Study Office
San Francisco, California, United States, 94124
Sponsors and Collaborators
Stanford University
University of California, San Francisco
University of California, Irvine
Investigators
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Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by Christopher Gardner, Stanford University:
Publications of Results:
Other Publications:
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Responsible Party: Christopher Gardner, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02843178    
Other Study ID Numbers: 36763
First Posted: July 25, 2016    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Gardner, Stanford University:
nutrition
food security
behavioral economics
Additional relevant MeSH terms:
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Cardiovascular Diseases