Cardiovascular Diseases Clinical Trial
Official title:
New Tools for Lasting Lifestyle Changes Among Inactive Obese People at Risk of Cardiovascular Disease (TLC)
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.
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.
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