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

University of Oulu

Status: Active, not recruiting

Conditions: Obesity

Treatments: Behavioral: Group counseling; Behavioral: Persuasive ICT support; Behavioral: Intensive group counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT04425304

Resepti-Onnikka

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Group counseling

Active Comparator group

Treatment:

Behavioral: Group counseling

Group counseling + persuasive ICT support

Experimental group

Treatment:

Behavioral: Persuasive ICT support

Behavioral: Group counseling

Intensive group counseling

Active Comparator group

Treatment:

Behavioral: Intensive group counseling

Intensive group counseling + persuasive ICT support

Experimental group

Treatment:

Behavioral: Persuasive ICT support

Behavioral: Intensive group counseling