Fruit and Vegetable Vouchers With and Without an SSB Tax (EVIDENCE)
The EValuating Interventions in Diabetogenic Environments Through Natural Controlled Experiments (EVIDENCE) Trial
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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San Francisco, California, 미국, 94158
- University of California
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Stanford, California, 미국, 94305
- Stanford University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: San Francisco
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.
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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.
다른 이름들:
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활성 비교기: Los Angeles
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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in fruit and vegetable consumption
기간: Month 0 to Month 6
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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).
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Month 0 to Month 6
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in nutrition quality per HEI score
기간: Month 0 to Month 6
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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).
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Month 0 to Month 6
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Change in nutrition quality per AHEI score
기간: Month 0 to Month 6
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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).
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Month 0 to Month 6
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Change in SSB consumption
기간: Month 0 to Month 6
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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).
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Month 0 to Month 6
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Change in overall caloric intake
기간: Month 0 to Month 6
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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).
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Month 0 to Month 6
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Overall percentage of vouchers redeemed
기간: Month 0 to Month 6
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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.
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Month 0 to Month 6
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dean Schillinger, MD, University of California, San Francisco
- 수석 연구원: Sanjay Basu, MD, PhD, Assistant Professor of Medicine
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
심혈관 질환에 대한 임상 시험
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University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국