Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes Residing in Urban Food Deserts (DASH-Life): Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Feasibility as assessed by the number of participants enrolled
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 120-159 mmHg (with or without medications.)
- •Serum potassium level >3.0 and <5 mmol/L,
- •Estimated glomerular filtration rate (eGFR) >=45 mL/min/1.73m
- •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.)
排除标准
- •Hypoglycemia requiring hospitalization or the assistance of another person in the last 6 months
- •Cardiovascular event within 6 months
- •On diabetes or weight loss medications such as glucagon-like peptide 1 (GLP-1), GLP-1/glucose-dependent insulin-releasing peptide (GIP), insulin, or any combination of these medications
- •HbA1c ≥ 10%
- •Type 1 diabetes
- •Baseline systolic BP < 100 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
研究组 & 干预措施
Self-Shopping DASH diet advice group (S-DASH)
干预措施: Self-Shopping DASH diet advice (Behavioral)
Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention (C-DASH)
干预措施: Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention (Behavioral)
结局指标
主要结局
Feasibility as assessed by the number of participants enrolled
时间窗: Baseline
The observed count of responses to the prescreening will be summarized. Recruitment yields at screening visit and randomization visit will be derived.
Acceptability as assessed by the Acceptability of the Intervention Measure survey
时间窗: 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.
次要结局
未报告次要终点