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

U

University of Oulu

Status

Active, not recruiting

Conditions

Obesity

Treatments

Behavioral: Group counseling
Behavioral: Persuasive ICT support
Behavioral: Intensive group counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT04425304
Resepti-Onnikka

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

200 participants in 4 patient groups

Group counseling
Active Comparator group
Treatment:
Behavioral: Group counseling
Group counseling + persuasive ICT support
Experimental group
Treatment:
Behavioral: Persuasive ICT support
Behavioral: Group counseling
Intensive group counseling
Active Comparator group
Treatment:
Behavioral: Intensive group counseling
Intensive group counseling + persuasive ICT support
Experimental group
Treatment:
Behavioral: Persuasive ICT support
Behavioral: Intensive group counseling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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