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Designing Food Voucher Programs to Reduce Disparities in Healthy Diets

Coupons for Healthy Intake Using Variable Economic Strategies (CHIVES)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02843178
Acronym
CHIVES
Enrollment
359
Registered
2016-07-25
Start date
2016-12-31
Completion date
2018-10-09
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

nutrition, food security, behavioral economics

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.

Detailed description

Participants for the trial will be recruited via advertisements at community sites including primary care clinics, housing assistance sites, and soup kitchens in the city of San Francisco. Recruitment materials will direct interested individuals to attend one of the study information sessions at a 'store front' site in San Francisco for an initial screening evaluation by the study staff, and a study orientation session to detail the study purpose, procedures, and participant rights. The orientation sessions will consist of a 60-minute session at a centrally-located room. After the orientation session, participants will be invited to sign a consent form, complete the baseline assessment, and be randomized to one of the four intervention conditions in a 1:1:1:1 allocation. We will use permuted block randomization so that sample sizes in each intervention group are nearly equal. Allocation sequence will be concealed prior to assignment; staff for sequence generation, allocation concealment, and implementation will be separate. Those agreeing to participate will sign a written consent form after the study orientation and before randomized to one of four voucher conditions, as part of our 2-by-2 study design: (1) vouchers targeted to fruits and vegetables and valid for sequential weeks of the month; (2) vouchers targeted to fruits and vegetables and valid over the entire month; (3) vouchers applicable to any food and valid for sequential weeks of the month; and (4) vouchers applicable to any food and valid over the entire month. Half of participants will receive a blue voucher valid for any food (not tobacco, alcohol, or prepared foods), while the other half will receive a green voucher valid only for qualified fruits and vegetables (fresh or frozen fruits, vegetables, or herbs without added sugars or fats, to correspond to the eligibility guidelines of existing voucher programs). All vouchers will have the same individual value ($5), but one half of participants will receive four vouchers that are each valid for the whole month (a lump sum payment of $20), while the other half will receive four vouchers that are each valid for one sequential week of the month, as labeled on the voucher (a distributed payment of $5 per week). Therefore, all intervention groups will be balanced on time and attention from study staff, as well as effort to obtain the vouchers. By having all vouchers in small increments of $5, we minimize the need for a large voucher to be spent all at once, reducing the risk of food spoilage affecting intervention effectiveness. Having all vouchers be worth the same value also simplifies processing of the voucher at the level of the food vendor. We have specifically designed the monetary amounts of the trial to be sufficient for achieving nutritional goals (the Healthy People 2020 goal of consuming 1.4 cups of fruits and vegetables per day), but not be unduly large so as to be coercive to low-income populations. Vouchers will be mailed to each participant toward the end of the month prior that the vouchers were valid for, i.e. vouchers for March 2017 will be mailed at the end of February 2017. Vouchers will be prepared following the guidelines in the Trial Protocol. To redeem vouchers, participants present the voucher to a cashier, and sign and date the voucher at the time of redemption. The cashier processes the voucher just as they processes vouchers for the Women, Infants and Children's program or manufacturer's coupons, and the vendor then submits the redeemed voucher for payment (the financial infrastructure is handled by the San Francisco General Hospital Foundation). The names of the vendors who will accept the vouchers are printed on each voucher, along with their address and business hours. All voucher rules will be reviewed with participants during the orientation session. We will continue routine meetings with the neighborhood food vendors' managers to ensure continued active participation and correct usage of the vouchers. Following informed consent, participants will complete a baseline survey and a 24-hour dietary recall before being randomized to one of the four study conditions. The recall includes three distinct passes to obtain a participant's food intake during the previous 24 hours-a quick list, a detailed description, and a review-including foods obtained at home and away from home, and including bartered, foraged, food pantry and other non-purchased items. Participants are provided standard 2-dimensional booklets for reference to portion sizes. Our research assistants are blinded to the participant's intervention arm and skilled in guiding dietary recalls among diverse participants in a non-judgmental, comprehensive manner. The baseline recall will be conducted in person at the store front site; subsequent recalls will be conducted over telephone. Recalls will be performed during week 1 and week 4 of the month-0 (baseline), month-6, and month-12 assessments. Two recalls each will be done during week 1 (one weekday and one weekend) and two during week 4 (one weekday and one weekend) of the assessment months. This minimizes the number of recalls required to capture intra-person variation in diet between weekdays and weekends, while simultaneously capturing the monthly consumption cycle among participants (the key hypothesized mediator for the lump sum vs. distributed voucher effect). In addition to dietary recalls, research assistants will orally administer surveys to prevent literacy-based biases, consistent with recent Institute of Medicine recommendations. These 20-minute surveys will be conducted at months 0, 6, and 12 and will cover attitudes and preferences regarding the vouchers and fruits and vegetables generally, shopping patterns, food expenditures, household environment, and food insecurity. Each participant will receive vouchers for a total of 6 months. The participants will then be tracked by the recruitment/retention coordinator through brief telephone contact monthly to ensure retention until they complete the month 12 survey and dietary recall (6 months after the end of the intervention), after which they are discharged from the study. In addition to participants who receive the vouchers, we will also conduct a brief survey with managers of the ten stores who have signed memos of understanding with the City of San Francisco and San Francisco General Foundation to accept the vouchers. The managers will be given informed consent forms to consider participating in a post- intervention survey. The paper-based vendor survey will be hand-delivered to vendors' managers to assess: (i) whether managers have any difficulties with the voucher system and whether those difficulties are at the point of sale, at the point of reimbursement, and/or when answering questions to customers about the vouchers; (ii) what if any activities were used by vendors to promote fruit and vegetable purchases during the voucher trial period; (iii) what if any activities they had engaged in to sell more fruits and vegetables; and (iv) a free text entry to elicit what changes vendors would propose to the voucher system in future

Interventions

BEHAVIORALVouchers

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.

Sponsors

University of California, San Francisco
CollaboratorOTHER
University of California, Irvine
CollaboratorOTHER
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 6Baseline and Month 6Fruit and vegetable intake (measured in Cup-equivalents) at the end of month 6 of the trial, assessed by 24-hour dietary recall

Secondary

MeasureTime frameDescription
Change in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 12Baseline and Month 12Fruit 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.
Change in Healthy Eating Index From Baseline to Month 6Baseline and Month 6Healthy 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).
Voucher Utilization RateMonths 1-6 of interventionPercent of vouchers utilized by participants in each study arm

Other

MeasureTime frameDescription
Voucher Ease of Use SurveyMonth 6Survey 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.
Self-reported Height SurveyMonth 6Self-reported height by phone survey.
Food Security SurveyBaseline, Month 6, and Month 12This 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.
Self-reported Weight SurveyMonth 6Self-reported weight by phone survey.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
86
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. 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.
90
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. 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.
92
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. 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.
91
Total359

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up8863
Overall StudyWithdrawal by Subject0011

Baseline characteristics

Characteristic1: Distributed, Targeted VouchersTotal4: Lump Sum, Untargeted Vouchers3: Distributed, Untargeted Vouchers2: Lump Sum, Targeted Vouchers
Age, Continuous52.2 years
STANDARD_DEVIATION 13.1
51.5 years
STANDARD_DEVIATION 13.5
50.9 years
STANDARD_DEVIATION 13.5
52.4 years
STANDARD_DEVIATION 14.1
50.7 years
STANDARD_DEVIATION 13.4
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants56 Participants15 Participants13 Participants14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
72 Participants303 Participants76 Participants79 Participants76 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants9 Participants1 Participants4 Participants2 Participants
Race (NIH/OMB)
Asian
17 Participants61 Participants14 Participants13 Participants17 Participants
Race (NIH/OMB)
Black or African American
24 Participants90 Participants21 Participants21 Participants24 Participants
Race (NIH/OMB)
More than one race
2 Participants25 Participants7 Participants8 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants2 Participants1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants30 Participants8 Participants5 Participants11 Participants
Race (NIH/OMB)
White
35 Participants142 Participants39 Participants40 Participants28 Participants
Region of Enrollment
United States
86 participants359 participants91 participants92 participants90 participants
Sex: Female, Male
Female
56 Participants234 Participants57 Participants61 Participants60 Participants
Sex: Female, Male
Male
30 Participants125 Participants34 Participants31 Participants30 Participants
SNAP participation22 Participants99 Participants25 Participants26 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 860 / 900 / 920 / 91
other
Total, other adverse events
0 / 860 / 900 / 920 / 91
serious
Total, serious adverse events
0 / 860 / 900 / 920 / 91

Outcome results

Primary

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

Time frame: Baseline and Month 6

ArmMeasureValue (MEAN)
1: Distributed, Targeted VouchersChange in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 60.18 Change in Cup-equivalents, mo 0 to mo 6
2: Lump Sum, Targeted VouchersChange in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 60.08 Change in Cup-equivalents, mo 0 to mo 6
3: Distributed, Untargeted VouchersChange in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 60.09 Change in Cup-equivalents, mo 0 to mo 6
4: Lump Sum, Untargeted VouchersChange in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 60.04 Change in Cup-equivalents, mo 0 to mo 6
Secondary

Change in Cup-equivalents of Fruit and Vegetable Intake From Baseline to 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.

Time frame: Baseline and Month 12

ArmMeasureValue (MEAN)
1: Distributed, Targeted VouchersChange in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 120.0316 Change in Cup-equivalents, mo 0 to mo 12
2: Lump Sum, Targeted VouchersChange in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 120.0180 Change in Cup-equivalents, mo 0 to mo 12
3: Distributed, Untargeted VouchersChange in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 12-0.0849 Change in Cup-equivalents, mo 0 to mo 12
4: Lump Sum, Untargeted VouchersChange in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 120.2112 Change in Cup-equivalents, mo 0 to mo 12
Secondary

Change in Healthy Eating Index From Baseline to 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).

Time frame: Baseline and Month 6

ArmMeasureValue (MEAN)
1: Distributed, Targeted VouchersChange in Healthy Eating Index From Baseline to Month 61.2 change in Index from mo 0 to mo 6
2: Lump Sum, Targeted VouchersChange in Healthy Eating Index From Baseline to Month 60.7 change in Index from mo 0 to mo 6
3: Distributed, Untargeted VouchersChange in Healthy Eating Index From Baseline to Month 62.1 change in Index from mo 0 to mo 6
4: Lump Sum, Untargeted VouchersChange in Healthy Eating Index From Baseline to Month 6-0.3 change in Index from mo 0 to mo 6
Secondary

Voucher Utilization Rate

Percent of vouchers utilized by participants in each study arm

Time frame: Months 1-6 of intervention

ArmMeasureValue (NUMBER)
1: Distributed, Targeted VouchersVoucher Utilization Rate66.8 Percent of vouchers utilized
2: Lump Sum, Targeted VouchersVoucher Utilization Rate81.8 Percent of vouchers utilized
3: Distributed, Untargeted VouchersVoucher Utilization Rate67.8 Percent of vouchers utilized
4: Lump Sum, Untargeted VouchersVoucher Utilization Rate80.4 Percent of vouchers utilized
Other Pre-specified

Food Security Survey

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.

Time frame: Baseline, Month 6, and Month 12

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
1: Distributed, Targeted VouchersFood Security Surveymonth 1229 Participants
1: Distributed, Targeted VouchersFood Security Surveymonth 627 Participants
1: Distributed, Targeted VouchersFood Security Surveybaseline24 Participants
2: Lump Sum, Targeted VouchersFood Security Surveymonth 630 Participants
2: Lump Sum, Targeted VouchersFood Security Surveybaseline27 Participants
2: Lump Sum, Targeted VouchersFood Security Surveymonth 1232 Participants
3: Distributed, Untargeted VouchersFood Security Surveybaseline37 Participants
3: Distributed, Untargeted VouchersFood Security Surveymonth 642 Participants
3: Distributed, Untargeted VouchersFood Security Surveymonth 1231 Participants
4: Lump Sum, Untargeted VouchersFood Security Surveymonth 638 Participants
4: Lump Sum, Untargeted VouchersFood Security Surveymonth 1233 Participants
4: Lump Sum, Untargeted VouchersFood Security Surveybaseline29 Participants
Other Pre-specified

Self-reported Height Survey

Self-reported height by phone survey.

Time frame: Month 6

ArmMeasureValue (MEAN)
1: Distributed, Targeted VouchersSelf-reported Height Survey65.64 inches
2: Lump Sum, Targeted VouchersSelf-reported Height Survey66.03 inches
3: Distributed, Untargeted VouchersSelf-reported Height Survey66.14 inches
4: Lump Sum, Untargeted VouchersSelf-reported Height Survey66.17 inches
Other Pre-specified

Self-reported Weight Survey

Self-reported weight by phone survey.

Time frame: Month 6

ArmMeasureValue (MEAN)
1: Distributed, Targeted VouchersSelf-reported Weight Survey181.30 pounds
2: Lump Sum, Targeted VouchersSelf-reported Weight Survey172.77 pounds
3: Distributed, Untargeted VouchersSelf-reported Weight Survey178.50 pounds
4: Lump Sum, Untargeted VouchersSelf-reported Weight Survey174.43 pounds
Other Pre-specified

Voucher Ease of Use Survey

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.

Time frame: Month 6

ArmMeasureValue (MEAN)
1: Distributed, Targeted VouchersVoucher Ease of Use Survey2.87 score on a scale
2: Lump Sum, Targeted VouchersVoucher Ease of Use Survey2.72 score on a scale
3: Distributed, Untargeted VouchersVoucher Ease of Use Survey2.56 score on a scale
4: Lump Sum, Untargeted VouchersVoucher Ease of Use Survey2.58 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026