TLC: Tools for Lasting Lifestyle Changes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
Instructor-led training twice a week,
One individual nutritionist counselling session of followed by three group based two-hour nutritionist counselling focusing on practical food purchase and preparation and
Three two-hour psychologist-led group counselling sessions based on implementation intentions theory and practical help to make if-then plans focusing on changing food and activity habits.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline physical activity at 6 months [6 months]
Change from baseline steps counted by activity trackers (Polar M430) at 6 months
Secondary Outcome Measures
- Change from baseline central obesity at 6 months [6 months]
Change from baseline waist circumference (cm) at 6 months standardized measured
- Change from baseline VO2max at 6 months [6 months]
Change from baseline VO2max at 6 months measured on treadmill test
Eligibility Criteria
Criteria
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:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UiT the Arctic University of Norway | Tromsø | Norway | 9037 |
Sponsors and Collaborators
- University of Tromso
- University Hospital of North Norway
Investigators
- Principal Investigator: Sameline Grimsgaard, MD, MPH, PhD, Professor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-1100