The Effects of an Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
The aim of the trial is to study the effect of a lifestyle change program in patients with obesity and risk of cardiovascular diseases. The main focus is to motivate and support lifestyle changes.
Two different group counseling methods (intensive and standard) with or without internet support will be compared. Thus, the patients will be randomized into four arms. Patients will be recruited from local general practice teams. The intensive lifestyle counseling consists of 12 group counseling sessions and 2 personal counseling sessions. The standard counseling consists of 4 group sessions. The internet-based counseling contains aspects of cognitive behavior therapy and persuasive design system and consists of weekly reminders, tasks, self-monitoring, and reflection.
The main outcome is the decrease in body weight. Secondary outcomes are changes in eating behavior, eating habits, components of metabolic syndrome (waist circumference, plasma lipid and glucose values), and calculated scores of cardiometabolic condition, cardiovascular risk and adiposity.
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
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index 30 to 40 kg/m2
- •+ 2 risk factors of cardiovascular diseases:
- •Elevated blood pressure or hypertension
- •High LDL or hypocholesterolemic drug
- •Low HDL or hypocholesterolemic drug
- •Elevated triglyceride value or hypolipidemic drug
- •Elevated glucose value or diabetes medication
- •Access to email and internet
排除标准
- •Untreated hypothyroidism
- •Oral corticosteroid treatment
- •Pregnancy and lactation
- •Angina pectoris
- •Cardiac insufficiency
- •Coronary Heart Disease
- •Inability to speak Finnish
- •Anticipated lack of compliance
结局指标
主要结局
Change in body weight
时间窗: Baseline to 2 years
次要结局
未报告次要终点
研究者
Janne Hukkanen
Professor of Internal Medicine
University of Oulu