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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Group counseling; Behavioral: Intensive group counseling; Behavioral: Persuasive ICT support

• Registration Number: NCT04425304
• Lead Sponsor: University of Oulu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-02
• Study First Submitted: 2020-06-06
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Primary Completion: 2024-05-23
• Study Completion: 2024-05-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group counseling + persuasive ICT support	Group counseling	-
Intensive group counseling	Intensive group counseling	-
Intensive group counseling + persuasive ICT support	Intensive group counseling	-
Intensive group counseling + persuasive ICT support	Persuasive ICT support	-
Group counseling	Group counseling	-
Group counseling + persuasive ICT support	Persuasive ICT support	-

Primary Outcome Measures

Name	Time	Method
Change in body weight	Baseline to 2 years

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland