Effects of Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients

Study Overview
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Brief Summary
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The aim of the trial is to study the effect of a lifestyle change program in patients with obesity and risk of cardiovascular diseases. The main focus is to motivate and support lifestyle changes. Two different group counseling methods (intensive and standard) with or without internet support will be compared. Thus, the patients will be randomized into four arms. Patients will be recruited from local general practice teams. The intensive lifestyle counseling consists of 12 group counseling sessions and 2 personal counseling sessions. The standard counseling consists of 4 group sessions. The internet-based counseling contains aspects of cognitive behavior therapy and persuasive design system and consists of weekly reminders, tasks, self-monitoring, and reflection. The main outcome is the decrease in body weight. Secondary outcomes are changes in eating behavior, eating habits, components of metabolic syndrome (waist circumference, plasma lipid and glucose values), and calculated scores of cardiometabolic condition, cardiovascular risk and adiposity.

Official Title
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The Effects of an Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Group counseling
* Behavioral: Intensive group counseling
* Behavioral: Persuasive ICT support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index 30 to 40 kg/m2 + 2 risk factors of cardiovascular diseases: Elevated blood pressure or hypertension High LDL or hypocholesterolemic drug Low HDL or hypocholesterolemic drug Elevated triglyceride value or hypolipidemic drug Elevated glucose value or diabetes medication Smoking Access to email and internet Exclusion Criteria: Untreated hypothyroidism Oral corticosteroid treatment Pregnancy and lactation Angina pectoris Cardiac insufficiency Coronary Heart Disease Inability to speak Finnish Anticipated lack of compliance

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group counseling<br> | Behavioral: Group counseling<br>* 4 times<br>|
| Experimental: Group counseling + persuasive ICT support<br> | Behavioral: Group counseling<br>* 4 times<br>Behavioral: Persuasive ICT support<br>* Weekly reminders for 12 months<br>|
| Active Comparator: Intensive group counseling<br> | Behavioral: Intensive group counseling<br>* 14 times<br>|
| Experimental: Intensive group counseling + persuasive ICT support<br> | Behavioral: Intensive group counseling<br>* 14 times<br>Behavioral: Persuasive ICT support<br>* Weekly reminders for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | Baseline to 2 years |