New Tools for Lasting Lifestyle Changes Among Inactive Obese People at Risk of Cardiovascular Disease (TLC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change from baseline physical activity at 6 months
研究概览
简要总结
Pilot and feasibility study; a complex intervention focusing on lifestyle change to increase physical activity and reduce cardiovascular disease (CVD) risk among high risk individuals.
详细描述
Interdisciplinary, mixed-method, prospective and single-arm exploratory study aimed to explore study feasibility, responsiveness, participants adherence and adverse events among the participants before deciding to proceed to full-scale evaluation.
Enrollment of max. 20 obese people (BMI>30) with sedentary lifestyle and increased CVD-risk (NORRISK2)..
Participants general health status including cardiopulmonary fitness will be assessed both before and after the intervention (blood pressure, ECG, spirometry, treadmill tests VO2max, blood tests, body composition by Dual-energy X-ray absorptiometry (DEXA) measurements) Participants´ functional capacity assessed by several range of motion tests. Participants nutritional and psychological status assessed by validated questionnaires.
Several blood-tests and ECG will be recorded at three months.
Daily activity level during and six months after the intervention period monitored by Polar M430 pulse watch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •Age 55-74 years
- •Moderate elevated NORRISK 2 score
- •Motivation for lifestyle change
- •Has agreed to attend and participate in a student study during the study period
- •Exclusion criteria: 1.External disease with short life expectancy 2.Diseases that limit physical activity in the project 3.Serious mental illness
- •Previous myocardial infarction 5.EKG changes that show severe rhythm disturbance, unstable angina or heart attack
- •5.EKG changes that show severe rhythm disturbance, unstable angina or heart attack:
排除标准
- 未提供
研究组 & 干预措施
'Lifestyle counselling and exercise' .
The study is a single-arm study where all participants undergo the same intervention 'Lifestyle counselling and exercise' .
干预措施: Lifestyle counselling and exercise (Behavioral)
结局指标
主要结局
Change from baseline physical activity at 6 months
时间窗: 6 months
Change from baseline steps counted by activity trackers (Polar M430) at 6 months
次要结局
- Change from baseline central obesity at 6 months(6 months)
- Change from baseline VO2max at 6 months(6 months)