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NCT04425304Completed

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

Source: ClinicalTrials.gov · Last updated 11 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
200 (actual)
First submitted
6 Jun 2020
Start date
2 Jun 2020
Primary completion date
23 May 2024
Lead sponsor
University of Oulu
Diseases
Obesity
NCT number
NCT04425304

What you commit to

  • Study type: Interventional
  • Participants enrolled: 200
  • From 2 Jun 2020 to the primary completion date, 23 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Oral corticosteroid treatment

Other illness

  • Angina pectoris
  • Cardiac insufficiency
  • Coronary Heart Disease

Other

  • Untreated hypothyroidism
  • Pregnancy and lactation
  • Inability to speak Finnish
  • Anticipated lack of compliance

Who the study is looking for

  • 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

Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Oulu University Hospital
Coordinator of this site? Confirm its status
OuluFinlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.