The EValuating Interventions in Diabetogenic Environments Through Natural Controlled Experiments (EVIDENCE) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 2
- 主要终点
- Change in fruit and vegetable consumption
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
24-hour dietary recalls are conducted by blinded registered dietitians
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Fruit and vegetable voucher (Behavioral)
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.
干预措施: Fruit and vegetable voucher (Behavioral)
结局指标
主要结局
Change in fruit and vegetable consumption
时间窗: Month 0 to Month 6
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).
次要结局
- Change in SSB consumption(Month 0 to Month 6)
- Change in nutrition quality per HEI score(Month 0 to Month 6)
- Overall percentage of vouchers redeemed(Month 0 to Month 6)
- Change in nutrition quality per AHEI score(Month 0 to Month 6)
- Change in overall caloric intake(Month 0 to Month 6)
研究者
Christopher Gardner
Assistant Professor of Medicine
Stanford University