在老年人中实施创新食品处方计划
在美国,大约 10% 的成年人很难找到水果和蔬菜等健康食品。 对于可能生病并且发现四处走动很困难的老年人来说更加困难,这使得获得健康食物变得困难。 研究人员正试图通过测试两种帮助老年人(65 岁及以上)获得营养食物的新方法来解决这个问题。 研究人员从老年人那里得到了很多帮助和想法,以使这些方法发挥最大作用。
这项研究在纽约州布法罗东区的伊利县医疗中心 (ECMC) 进行,那里居住着许多非裔美国人。 这个地方没有受到公平对待,所以当地商店里没有多少地方可以买到新鲜的水果和蔬菜。 ECMC 校园内设有三个诊所,可以帮助那些无法轻易获得健康食品的人。 我们研究的每位参与者都将被分入三个项目之一,每个项目持续 12 周,他们每周都会得到食物。
在“常规护理”计划中,医生开具处方,参与者获得一张代金券,可以在市场或商店购买更多水果和蔬菜。
在“农产品处方箱配送”项目中,一箱水果和蔬菜被送到参与者家中。 参与者可以在线选择自己喜欢的内容,也可以通过呼叫帮助者来选择。 如果他们不挑选,他们会得到一个普通的盒子。
在“送餐盒”项目中,参与者将三餐的食材装在一个盒子里。 参与者可以在线或通过电话选择自己喜欢的三餐。 如果参赛者不选择,将为参赛者选择三餐。
对于第二个和第三个程序,参与者将收到消息,提醒参与者何时选择食物、何时选择时间即将结束以及何时食物正在路上。 如果参与者无法使用消息或互联网,他们可以致电帮助者寻求支持。 研究人员相信,这项研究将表明,这些方法可以帮助难以获取食物的老年人多吃水果和蔬菜。 调查人员还将找出与纽约州布法罗地区通常的方式相比,哪种方式效果最好。
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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Buffalo、New York、美国、14214
- University at Buffalo
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参与标准
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
描述
纳入标准:
- 65岁或以上
- 英语会话
排除标准:
- 65岁以下
- 不会说英语
- 认知障碍(认知功能筛查)
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Produce Prescription Mobile Market
Usual care control is a produce prescription model prescribed by a clinician, providing funds to purchase approx.
9-11 servings of fruit and vegetables per person at designated mobile market provider(s).
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在流动市场购买水果和蔬菜的凭证
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实验性的:Produce Prescription Delivery
Intervention arm 1 is a healthy food delivery model, wherein the participant receives a customizable produce box providing approx.
9-11 servings of fruits and vegetables per person.
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果蔬盒配送
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实验性的:Healthy Meal Kit Delivery
Intervention arm 2 is a healthy meal kit delivery model providing all ingredients to make 3+ meals with approx.
9-11 servings of fruits and vegetables, with 6-9 meal options to choose from each week.
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烹饪健康膳食的食材送到家
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Average Percentage of Prescriptions Redeemed
大体时间:Average over the 12-week intervention
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Redemption will be measured as the weekly usage of the interventions.
Participants will receive an automatic notification after each delivery (or weekly for the usual care arm) and will be asked to confirm that they received their delivery/redeemed their prescription.
If they do not initially confirm, they will receive two reminder notifications.
Redemption will be measured as the percentage of all 12 deliveries/mobile market visits that are either confirmed via post on the usage survey.
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Average over the 12-week intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Average Percentage of Fruit and Vegetables Used
大体时间:Measured weekly for duration of 12-week intervention
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Usage will be measured in the self-reported weekly text surveys that will ask participants approximately what percentage of the fruits and vegetables that they receive was used by someone in their household: all (coded as 100%), most (coded as 75%), about half (coded as 50%), some (coded as 25%) and none (coded as 0%).
Answers from all completed surveys over 12 weeks will be averaged to get a percent of food usage for each participant.
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Measured weekly for duration of 12-week intervention
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Eligible Participants Who Were Interested in the Program
大体时间:Collected once per eligible individual during approximately 4-week recruitment period
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Program interest is defined as the percentage of the total eligible individuals that were referred to the program who were 1.) reachable for recruitment and 2.) did not decline participation via either opt-out letter or when contacted by researchers (those who declined prior to being provided detail on their assigned intervention).
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Collected once per eligible individual during approximately 4-week recruitment period
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Percent of Eligible Participants Enrolled
大体时间:Collected once per eligible individual during approximately 4-week recruitment period
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Program enrollment will be measured as the percentage of patients eligible and referred that decide to enroll.
Patients who choose not to enroll will be asked to provide more information on why they do not want to enroll.
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Collected once per eligible individual during approximately 4-week recruitment period
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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水果和蔬菜消费
大体时间:在基线和 12 周干预期后收集
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2021行为危险因素监测系统水果和蔬菜模块
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在基线和 12 周干预期后收集
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营养安全
大体时间:在基线和 12 周干预期后收集
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营养安全将采用美国农业部粮食安全调查模块(评估可及性和负担能力)与一套新的营养安全措施相结合来衡量,这些新的营养安全措施补充了美国农业部的工具,以帮助捕获营养安全的其余支柱(可用性) 、利用率和稳定性)
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在基线和 12 周干预期后收集
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购买、准备和食用新鲜水果和蔬菜的自我效能感
大体时间:在基线和 12 周干预期后收集
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10 点李克特量表(强烈不同意到强烈同意,其中正分表示积极信念)使用根据购物者研究改编的项目选择,其中自我效能被证明与营养行为相关。
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在基线和 12 周干预期后收集
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吃水果和蔬菜的障碍
大体时间:在基线和 12 周干预期后收集
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之前在低收入成年人中测试过的 4 点李克特量表(强烈不同意到强烈同意,其中正分数表示积极信念)反映了文献中发现的常见好处/障碍。
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在基线和 12 周干预期后收集
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Health Status and Disease Risk
大体时间:Collected at baseline and after 12-week intervention period
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Health status and disease risk will be measured using one subscale of the RAND 36-Item Short Form Health Survey (SF-36): 1.) General health: 1 item with a 5-point Likert scale where 1 is excellent and 5 is poor; this is combined with the EQ-5D-5L survey, which consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
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Collected at baseline and after 12-week intervention period
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合作者和调查者
调查人员
- 首席研究员:Lucia Leone, PhD、University at Buffalo
- 首席研究员:Jill Tirabassi, MPH, MD、University at Buffalo
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
想要访问医疗保健 x 食品计划数据的研究人员将被要求在 AHA 精准医学平台上创建一个帐户,并获得使用该数据集提出的研究的批准。
此外,任何希望访问数据的人都可以通过电子邮件(lucialeo@buffalo.edu, jilltira@buffalo.edu)。
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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