The Effects of an Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oulu
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in body weight
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Intensive group counseling + persuasive ICT support
Intervention: Intensive group counseling (Behavioral)
Intensive group counseling + persuasive ICT support
Intervention: Persuasive ICT support (Behavioral)
Group counseling
Intervention: Group counseling (Behavioral)
Group counseling + persuasive ICT support
Intervention: Group counseling (Behavioral)
Group counseling + persuasive ICT support
Intervention: Persuasive ICT support (Behavioral)
Intensive group counseling
Intervention: Intensive group counseling (Behavioral)
Outcomes
Primary Outcomes
Change in body weight
Time Frame: Baseline to 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Janne Hukkanen
Professor of Internal Medicine
University of Oulu