Tools for Lasting Lifestyle Changes (TLC)
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|ClinicalTrials.gov Identifier: NCT03807323|
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Lifestyle Risk Reduction||Behavioral: Lifestyle counselling and exercise||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Feasibility study|
|Masking:||None (Open Label)|
|Official Title:||New Tools for Lasting Lifestyle Changes Among Inactive Obese People at Risk of Cardiovascular Disease (TLC)|
|Actual Study Start Date :||September 25, 2017|
|Actual Primary Completion Date :||October 4, 2018|
|Actual Study Completion Date :||October 4, 2018|
Experimental: 'Lifestyle counselling and exercise' .
The study is a single-arm study where all participants undergo the same intervention 'Lifestyle counselling and exercise' .
Behavioral: Lifestyle counselling and exercise
The program consists of:
- 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
- Change from baseline central obesity at 6 months [ Time Frame: 6 months ]Change from baseline waist circumference (cm) at 6 months standardized measured
- Change from baseline VO2max at 6 months [ Time Frame: 6 months ]Change from baseline VO2max at 6 months measured on treadmill test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807323
|UiT the Arctic University of Norway|
|Tromsø, Norway, 9037|
|Principal Investigator:||Sameline Grimsgaard, MD, MPH, PhD||Professor|