Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk in Vulnerable Populations: the MeDiPA Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in 24-hour ambulatory DBP among subjects, after 6 months.
研究概览
简要总结
The purpose of this randomized controlled trial is to test the effects of a hypocaloric Mediterranean diet or of physical activity in participants who take at least 2 antihypertensive drugs but do not reach blood pressure treatment goal.
This study is a randomized, controlled, single-center, parallel group trial with three arms: hypocaloric Mediterranean diet (MeDi), physical activity (PA), or control. The control group will receive usual care (no intervention). This study will not be blinded.
The interventions will last 6 months, while the study follow-up will last 12 months. Four study visits will take place: baseline, at 3 months, at 6 months, at 12 months. The primary outcome is change in mean 24-hour ambulatory systolic blood pressure and diastolic blood pressure among groups after 6 months of intervention. Secondary and exploratory outcomes include change in other measures of blood pressure, body composition, other markers of cardiometabolic disease, inflammation markers, safety outcomes, and quality of life, among others.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •18 - 70 years
- •Taking ≥ 2 antihypertensive drugs (includes combination therapy)
- •Office SBP ≥ 140mmHg and/or DBP ≥ 90mmHg on two occasions
- •BMI 25 - 40 kg/m2
- •Waist circumference ≥ 88 cm (women) or ≥ 102 cm (men)
- •Sedentary lifestyle (< 150 minutes/week of moderate intensity physical activity)
- •Weight stable (± 5 kg in the last 6 months)
- •Not on a weight loss diet
- •Willing to comply to an intervention of either a hypocaloric Mediterranean diet or physical activity (or control) for 6 months
排除标准
- •Unable to provide informed consent
- •Pregnant or lactating
- •Office BP ≥ 160/100 mmHg
- •Diabetes mellitus type 1
- •History of cardiovascular disease (including uncompensated heart failure, recent infarction or stroke in the last 6 months, severe arrhythmia, heart failure or unstable angina pectoris)
- •Chronic kidney disease stages 4 or 5
- •Cancer in the last 5 years
- •Changes in concurrent medication (anti-hypertensives, anti-diabetics, lipid-lowering drugs) in the last 3 months
- •Regular use of oral corticosteroids in excess of 5 mg prednisolone (or equivalent) during the last month
- •Use of GLP-1 analogues for < 1 year
- •Drug or alcohol abuse
- •Eating disorders or severe dietary restrictions
- •Impediments to physical activity at recommended levels due to musculoskeletal and other conditions.
结局指标
主要结局
Change in 24-hour ambulatory DBP among subjects, after 6 months.
时间窗: baseline to 6 months
24-hour ambulatory blood pressure will be measured with a device that allows free-living. Change = (6 month measurement - baseline measurement).
Change in 24-hour ambulatory SBP among subjects, after 6 months.
时间窗: Baseline to 6 months
24-hour ambulatory blood pressure will be measured with a device that allows free-living. Change = (6 month measurement - baseline measurement).
次要结局
- Change in other measures of blood pressure, within and among subjects, after 6 and 12 months.(Baseline to 6 months, baseline to 12 months)
- Change in body composition, within and among subjects, after 6 months.(Baseline to 6 months)
- Change in safety outcomes, within and among subjects, after 6 and 12 months.(Baseline to 6 months, baseline to 12 months)
- Change in markers of cardiometabolic risk, within and among subjects, after 6 and 12 months.(Baseline to 6 months, baseline to 12 months)
- Change in inflammation markers, within and among subjects, after 6 and 12 months.(Baseline to 6 months, baseline to 12 months)
研究者
Kari Anne Sveen
MD, PhD
Oslo University Hospital