Tools for Lasting Lifestyle Changes

Study Overview
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Brief Summary
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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
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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.

Official Title
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New Tools for Lasting Lifestyle Changes Among Inactive Obese People at Risk of Cardiovascular Disease (TLC)

Conditions
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Cardiovascular Diseases, Lifestyle Risk Reduction

Intervention / Treatment
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* Behavioral: Lifestyle counselling and exercise


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 'Lifestyle counselling and exercise' .<br>The study is a single-arm study where all participants undergo the same intervention 'Lifestyle counselling and exercise' . | Behavioral: Lifestyle counselling and exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline physical activity at 6 months | Change from baseline steps counted by activity trackers (Polar M430) at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline central obesity at 6 months | Change from baseline waist circumference (cm) at 6 months standardized measured | 6 months | 
| Change from baseline VO2max at 6 months | Change from baseline VO2max at 6 months measured on treadmill test | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary intervention