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

May 8, 2023 updated by: Janne Hukkanen, University of Oulu

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90029 OYS
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group counseling
Behavioral: Group counseling
4 times
Experimental: Group counseling + persuasive ICT support
Behavioral: Group counseling
4 times
Behavioral: Persuasive ICT support
Weekly reminders for 12 months
Active Comparator: Intensive group counseling
Behavioral: Intensive group counseling
14 times
Experimental: Intensive group counseling + persuasive ICT support
Behavioral: Persuasive ICT support
Weekly reminders for 12 months
Behavioral: Intensive group counseling
14 times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight
Time Frame: Baseline to 2 years
Baseline to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Investigators

  • Principal Investigator: Janne Hukkanen, MD, PhD, University of Oulu, Oulu University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2020

Primary Completion (Anticipated)

August 31, 2024

Study Completion (Anticipated)

August 31, 2024

Study Registration Dates

First Submitted

June 6, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Resepti-Onnikka

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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