Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group counseling | Active Comparator |
| |
| Group counseling + persuasive ICT support | Experimental |
| |
| Intensive group counseling | Active Comparator |
| |
| Intensive group counseling + persuasive ICT support | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group counseling | Behavioral | 4 times |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Baseline to 2 years |
Not provided
Not provided
Inclusion Criteria:
Body mass index 30 to 40 kg/m2
+ 2 risk factors of cardiovascular diseases:
Access to email and internet
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janne Hukkanen, MD, PhD | University of Oulu, Oulu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Oulu | 90029 OYS | Finland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intensive group counseling | Behavioral | 14 times |
|
| Persuasive ICT support | Behavioral | Weekly reminders for 12 months |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |