Tools for Lasting Lifestyle Changes (TLC)
New Tools for Lasting Lifestyle Changes Among Inactive Obese People at Risk of Cardiovascular Disease (TLC)
研究概览
详细说明
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.
The participants will be interviewed with focus on their prior health, activity habits and intervention experiences at three months and six months after end of the intervention. Two focus-group interviews at end of intervention.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Tromsø、挪威、9037
- UiT The Arctic University of Norway
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
Inclusion Criteria:
- Age 55-74 years
- BMI> 30
- 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 4. 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:
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：'Lifestyle counselling and exercise' .
The study is a single-arm study where all participants undergo the same intervention 'Lifestyle counselling and exercise' .
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The program consists of:
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change from baseline physical activity at 6 months
大体时间：6 months
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Change from baseline steps counted by activity trackers (Polar M430) at 6 months
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline central obesity at 6 months
大体时间：6 months
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Change from baseline waist circumference (cm) at 6 months standardized measured
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6 months
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Change from baseline VO2max at 6 months
大体时间：6 months
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Change from baseline VO2max at 6 months measured on treadmill test
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6 months
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合作者和调查者
调查人员
- 首席研究员：Sameline Grimsgaard, MD, MPH, PhD、Professor
出版物和有用的链接
一般刊物
- Deraas TS, Hopstock L, Henriksen A, Morseth B, Sand AS, Njolstad I, Pedersen S, Sagelv E, Johansson J, Grimsgaard S. Complex lifestyle intervention among inactive older adults with elevated cardiovascular disease risk and obesity: a mixed-method, single-arm feasibility study for RESTART-a randomized controlled trial. Pilot Feasibility Stud. 2021 Oct 27;7(1):190. doi: 10.1186/s40814-021-00921-0.
- Hopstock LA, Deraas TS, Henriksen A, Martiny-Huenger T, Grimsgaard S. Changes in adiposity, physical activity, cardiometabolic risk factors, diet, physical capacity and well-being in inactive women and men aged 57-74 years with obesity and cardiovascular risk - A 6-month complex lifestyle intervention with 6-month follow-up. PLoS One. 2021 Aug 25;16(8):e0256631. doi: 10.1371/journal.pone.0256631. eCollection 2021.
- Henriksen A, Sand AS, Deraas T, Grimsgaard S, Hartvigsen G, Hopstock L. Succeeding with prolonged usage of consumer-based activity trackers in clinical studies: a mixed methods approach. BMC Public Health. 2020 Aug 27;20(1):1300. doi: 10.1186/s12889-020-09406-w.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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研究美国 FDA 监管的设备产品
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