NCT07130539进行中（未招募）不适用
Mediterranean-DASH Intervention for Neurodegenerative Delay and High-Intensity Interval Training to Improve Blood Pressure and Other Cardiovascular Disease Risk Factors in Adults With Hypertension and Overweight/Obesity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To determine the feasibility of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT in adults with HTN and overweight/obesity.
研究概览
简要总结
This pilot study examines whether a 4-week diet and exercise intervention can improve blood pressure, heart health, and sleep in physically inactive individuals with high blood pressure and overweight or obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 74 years old
- •BMI 25 - 39.9 kg/m2 (for measured BMI)
- •Clinically diagnosed hypertension (physical medical record showing diagnosis of hypertension) with or without current medication use (SPB < 160 mm Hg, DBP < 100 mm Hg)
- •Physically inactive < 7,500 steps per day (measured on Fitbit over 1-week)
- •No current injury, illness, or joint issue that prevents participation in exercise
- •Able to read and speak English
- •Willingness to participate and give informed written consent
- •Willingness to share medical record indicating diagnosis of HTN and current medication use
排除标准
- •Pregnant, breastfeeding, lactating
- •Current smoker
- •Food allergy or lactose intolerance
- •Height > 6 foot 6 inches (78 inches)
- •Blood pressure ≥ 160/100 mm Hg (Contraindication to exercise testing)
- •History of diagnosed cardiovascular diseases including heart attack, stroke, irregular heartbeat such as atrial fibrillation, coronary artery or peripheral artery disease, or heart failure
- •History of liver, kidney, or metabolic disease (including type I or II diabetes)
- •History of cancer
- •Diagnosed moderate to severe obstructive sleep apnea, CPAP use, insomnia, h/o other sleep disorder
- •Night shift and/or rotating shift worker (current or in the past 2 years)
- •Current use of sleep medications or sleep aids
- •Excessive alcohol intake - ≥ 8 drinks per week in women, ≥ 15 drinks per week in men
- •History of gastric bypass or other weight loss surgery
- •Current use of metformin, insulin, dietary supplements or drugs for glycemic control or weight loss
- •Weight stable for the last 2 months (< 5 pounds body weight change)
- •Currently following a special diet for weight loss (Keto, Atkins, Intermittent Fasting)
- •A "yes" response to any questions on the PAR-Q (excluding Question 6 on use of BP medications)
- •Exercise training (≥ 2 days per week structured aerobic and resistance training at gym)
- •Prior hospitalization for COVID-19
- •Any medications or supplements that may alter study outcomes as determined by study PI
结局指标
主要结局
To determine the feasibility of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT in adults with HTN and overweight/obesity.
时间窗: From baseline to end of treatment at 4 weeks
Adherence to the lifestyle intervention will be determined by ≥ 75% supervised exercise training visits completed and ≥ 75% dietary compliance.
次要结局
- To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve nocturnal blood pressure in adults with HTN and overweight/obesity.(At baseline and at the end of the 4 week intervention)
- To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to lower blood pressure in adults with HTN and overweight/obesity.(Baseline and end of intervention at 4 weeks)
- To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve cardiorespiratory fitness in adults with HTN and overweight/obesity.(Baseline and end of intervention at 4 weeks)
- To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve cardiometabolic blood biomarkers in adults with HTN and overweight/obesity.(At baseline and end of the intervention at 4 weeks)
- To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to lower visceral fat in adults with HTN and overweight/obesity.(Baseline and end of intervention at 4 weeks)
- To evaluate the efficacy of a 4-week novel lifestyle intervention consisting of a MIND diet and HIIT to improve quality of life in adults with HTN and overweight/obesity.(Baseline and at the end of the intervention at 4 weeks)
研究者
Wesley Tucker
Associate Professor of Nutrition
Texas Woman's University
研究点 (2)
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