Effects of Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients
NCT ID: NCT04425304
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2020-06-02
2024-05-23
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Group counseling
Group counseling
4 times
Group counseling + persuasive ICT support
Group counseling
4 times
Persuasive ICT support
Weekly reminders for 12 months
Intensive group counseling
Intensive group counseling
14 times
Intensive group counseling + persuasive ICT support
Intensive group counseling
14 times
Persuasive ICT support
Weekly reminders for 12 months
Interventions
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Group counseling
4 times
Intensive group counseling
14 times
Persuasive ICT support
Weekly reminders for 12 months
Eligibility Criteria
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Inclusion Criteria
* \+ 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
* Oral corticosteroid treatment
* Pregnancy and lactation
* Angina pectoris
* Cardiac insufficiency
* Coronary Heart Disease
* Inability to speak Finnish
* Anticipated lack of compliance
30 Years
65 Years
ALL
No
Sponsors
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University of Oulu
OTHER
Responsible Party
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Janne Hukkanen
Professor of Internal Medicine
Principal Investigators
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Janne Hukkanen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oulu, Oulu University Hospital
Locations
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Oulu University Hospital
Oulu, , Finland
Countries
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Other Identifiers
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Resepti-Onnikka
Identifier Type: -
Identifier Source: org_study_id