Randomized Controlled Pilot Trial of Dietary Approached to Stop Hypertension (DASH) Feeding in Older Low Socioeconomic Adults Without Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of enrolled participants per week
研究概览
简要总结
This is a study of the DASH diet (Dietary Approaches to Stop Hypertension) in the exploration of effective strategies for Heart failure (HF) with preserved ejection fraction (HFPEF) prevention.
详细描述
This is a feasibility pilot, randomized clinical trial (RCT), DASH diet feeding trial in 40 older adults. It will also elicit trends in left ventricular remodeling and pathophysiology. This trial investigates the feasibility of performing a DASH diet RCT intervention in HFPEF prevention in older adults of low socioeconomic status (LSES).
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
- None
入排标准
- 年龄范围
- 60 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will have an education level of less than college as a surrogate marker of LSES.
排除标准
- •Participants should not have a diagnosis of heart failure or loop diuretics on their medication list in the EHR or symptoms of dyspnea, edema (assessed via questionnaire)
- •poorly controlled diabetes mellitus ( HBA 1c >9%)
- •or uncontrolled hypertension ( SBP>180, DBP>110)
- •cardiovascular event (MI, stroke, HF, angina, atrial fibrillation) within the previous six months
- •chronic diseases that might interfere with participation (dementia, schizophrenia, dialysis or transplant recipient patients)
- •body-mass index (the weight in kilograms divided by the square of the height in meters) of more than 35
研究组 & 干预措施
DASH diet group
Participants randomized to receive the DASH diet will be prescribed an isocaloric DASH diet using meals (lunch, dinner, snacks) prepared by a Clinical Research Metabolic Kitchen under the direction of a registered dietician. Participants will prepare their own breakfast from a menu. The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day.
干预措施: DASH Diet (Other)
Attention Control Group
Participants randomized to attention control will continue their usual diet, but they will be instructed to limit their sodium intake to 2300 mg/day. They will be requested and voluntarily agree to not make additional diet or exercise changes during the 12-week study.
干预措施: Usual diet (Other)
结局指标
主要结局
Number of enrolled participants per week
时间窗: Up to week 12
Proportion of participants that adhere to the to intervention
时间窗: Up to week 12
Number participants that were retained in the trial
时间窗: Up to week 12
次要结局
- Proportion of participants that adhere to the diet(Up to week 12)