NCT04425304

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Group counseling	4 times
BEHAVIORAL	Intensive group counseling	14 times
BEHAVIORAL	Persuasive ICT support	Weekly reminders for 12 months

Timeline

• Start date: 2020-06-02
• Primary completion: 2024-05-23
• Completion: 2024-05-23
• First posted: 2020-06-11
• Last updated: 2024-12-11

Locations

1 site across 1 country: Finland