The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Systolic blood pressure
研究概览
简要总结
This study will compare the low-sodium/low-fat DASH (Dietary Approaches to Stop Hypertension) diet with a very low-carbohydrate diet, helping us to better understand how two different dietary approaches may help participants control their blood pressure, lose weight, and reduce their blood glucose.
详细描述
Adults with overweight or obesity, hypertension, and prediabetes or type 2 diabetes are at a high risk of adverse health outcomes including stroke, renal disease, myocardial infarction, and premature death. Evidence suggests that the first-line treatment for adults with this triple burden should be a comprehensive diet and lifestyle intervention.
However, experts disagree about which diet should be recommended. The Dietary Approaches to Stop Hypertension (DASH) diet, a lower fat diet, is the de facto diet for adults with hypertension. A very low-carbohydrate (VLC) diet, a higher fat diet, is becoming the de facto diet for weight and glycemic control. In addition, a VLC diet may reduce blood pressure through weight loss and its impact on insulin (which alters renal sodium transport and leads to diuresis). Given that these two diets, DASH and very low-carbohydrate, are extremely promising options for this population, and the fact that they have never been compared in this population or any other, this comparison is strongly warranted.
The investigators propose to use an interprofessional team (with expertise in nursing, psychology, medicine, policy, nutrition, pharmacy, and behavioral interventions) to conduct a comparative effectiveness trial of two different diets for adults with this triple burden. The HERO Study (Hypertension, Diabetes, and Obesity Education Research Online) will compare the health effects of the DASH and VLC diets.
The investigators propose one aim:
Test the feasibility, acceptability, and preliminary comparative efficacy of the interventions. The investigators will randomize 140 adults with this triple burden to the DASH or VLC versions of the 4-month intervention. Outcome measures include intervention feasibility (recruitment and retention); acceptability (satisfaction with the intervention); and preliminary comparative efficacy as determined by changes in our primary outcome (systolic blood pressure), as well as exploratory secondary outcomes (weight, glycemic control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI of 25-50
- •Diagnosis pre-hypertension or hypertension (within the past 6 months) and current resting systolic blood pressure > 130 mmHg.
- •Diagnosis of either prediabetes or type 2 diabetes, defined as:
- •HbA1c of at least 5.7% or
- •Two-hour glucose tolerance test >140 mg/dL
- •Aged 21-70 years old
- •Access to the internet and text messaging
- •Ability to engage in light physical activity
- •Sufficient control over their food intake to adhere to study diets
- •Willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over 4-month trial
- •Participation in the trial approved by primary care provider, along with agreement to work with the participant and our research team to manage medication changes
排除标准
- •Non-English speaking
- •Current use of insulin, Dilantin, lithium, and warfarin
- •Inability to complete baseline measurements
- •Severe renal or hepatic insufficiency
- •Cardiovascular dysfunction, including diagnosis of:
- •Congestive heart failure
- •Arrhythmias
- •Cardiomyopathy
- •Valvular heart disease
- •Uncontrolled psychiatric disorder
- •Consumes >30 alcoholic drinks per week
- •Currently undergoing chemotherapy
- •Pregnant or planning to get pregnant in the next 12 months
- •Breastfeeding or less than 6 months' post-partum
- •Planned weight loss surgery or similar surgery performed previously
- •Vegan or vegetarian
- •Currently enrolled in a weight loss program or take weight loss supplements (that are not willing to be stopped before enrolling)
- •Expecting to move out of the area within 12 months
- •Any other medical condition that may make either diet dangerous as determined by the study medical team.
结局指标
主要结局
Systolic blood pressure
时间窗: 4 months
Measured with sphygmomanometer, assessed as change in blood pressure (systolic and diastolic blood pressure will both be measured, but systolic blood pressure is the main outcome)
次要结局
- Weight loss(4 months)
- Glycemic control(4 months)
研究者
Laura Saslow
Assistant Professor
University of Michigan