杂货以及针对高血压和2型糖尿病的成年人的多组分生活方式干预 (DASH-Life)
杂货以及居住在城市食品沙漠中的高血压和2型糖尿病的成年人的多组分生活方式干预（DASH-LIFE）：飞行员随机临床试验
People with high blood pressure and diabetes often have low levels of key nutrients as a result of not eating enough fresh fruits and vegetables. Research studies suggest that these nutrients can lower blood pressure and blood sugar. This study will investigate if providing encouragement to adopt this healthy and nutritious way of eating and providing guidance on weight management will lower blood pressure and blood sugar. The DASH-Life research study will recruit adults with hypertension and type 2 diabetes who live in Baltimore metro areas that don't have many stores selling healthy foods. The DASH-Life research study is 6 months long. Participants will be randomly assigned to one of two groups: 1) Self-Shopping DASH (S-DASH) diet advice group, or 2) Coaching DASH (C-DASH) diet advice group.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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-
Maryland
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Baltimore、Maryland、美国、21207
- Johns Hopkins ProHealth Clinical Research Unit
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 years or older
- Diabetes Mellitus Type 2 defined by: self-reported type 2 diabetes diagnosis, or HbA1c>=6.5%, or treatment of diabetes with diabetes medications(s)
- Baseline systolic BP 110-159 mmHg (with or without medications.)
- Serum potassium level >3.0 and <5 mmol/L,
- Estimated glomerular filtration rate (eGFR) >=45 mL/min/1.73m2.
- Willing and able to complete required procedures in English.
- Living in Healthy Food Priority Area in Baltimore; the US Department of Agriculture (USDA) defined low income, low access areas, or census blocks with area deprivation index (ADI) 60 and above (State Decile>=6.)
Exclusion Criteria:
- Hypoglycemia requiring hospitalization or the assistance of another person in the last 6 months
- Cardiovascular event within 6 months
- Unstable dose (i.e., change in the 3 months prior to screening or prior to randomization) glucagon-like peptide-1 (GLP-1) receptor agonists
- HbA1c ≥ 10%
- Type 1 diabetes
- Baseline systolic BP < 110 mmHg
- Weight >400 lbs due to the maximum weight on study scale
- Chronic disease that might interfere with trial participation
- Current participation in another clinical trial that might affect blood pressure, weight loss, diabetes, or ability to adhere to study procedures
- Current participation in program with conflicting dietary guidance (i.e., meal replacement or keto diets)
- Unwillingness or inability to adopt a DASH-like diet
- Planning to leave area in the next 6 months
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：自我购物破折号饮食咨询小组（S-DASH）
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Participants assigned to the S-DASH group will receive a brochure about the DASH eating plan. For the first three months, Participants will also receive a gift card to shop at a local supermarket. During months 4-6, participants will be asked to continue following the DASH eating plan listed in the brochure but will no longer be provided the grocery gift card. |
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实验性的：教练定向量身定制的破折号杂货以及生活方式干预（C-DASH）
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Participants assigned to the C-DASH group will meet by telephone with the study coach for 1 hour, and then have brief weekly conversations (about 15-30 minutes) by phone during the first three months. During these weekly calls, the study coach will assist participant with selecting fruits, vegetables, nuts, and beans. During months 4-6, the study coach will continue to work with participant to set goals for following the DASH-Life way of eating, but the study will no longer provide a weekly food allowance to purchase groceries. |
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 |
|---|---|---|
|
Feasibility as assessed by the number of participants enrolled
大体时间：Baseline
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The observed count of responses to the prescreening will be summarized. Recruitment yields at screening visit and randomization visit will be derived. |
Baseline
|
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Acceptability as assessed by the Acceptability of the Intervention Measure survey
大体时间：3 months
|
Acceptability of the intervention will be quantitatively measured by the Acceptability of Intervention Measure (AIM) survey. The survey consists of 4 items, each measured on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree). The score is calculated as the mean of the responses to the 4 items. A higher score is better. |
3 months
|
合作者和调查者
调查人员
- 首席研究员：Jessica Yeh, PhD、Johns Hopkins University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.