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Completed

NCT Number: NCT04425304

Effects of 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, 90029 OYS, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group counseling

Behavioral

4 times

Intensive group counseling

Behavioral

14 times

Persuasive ICT support

Behavioral

Weekly reminders for 12 months

Primary outcomes

  1. Change in body weight

    Time frame: Baseline to 2 years

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2020
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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