New Tools for Lasting Lifestyle Changes Among Inactive Obese People at Risk of Cardiovascular Disease (TLC)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- University of Tromso
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Change from baseline physical activity at 6 months
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from baseline physical activity at 6 months
Time Frame: 6 months
Change from baseline steps counted by activity trackers (Polar M430) at 6 months
Secondary Outcomes
- Change from baseline central obesity at 6 months(6 months)
- Change from baseline VO2max at 6 months(6 months)