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

NCT04425304 | Completed

• 1 other identifier: Resepti-Onnikka
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Baseline to 2 years

Study Arms (4)

Group counseling

ACTIVE COMPARATOR

Behavioral: Group counseling

Group counseling + persuasive ICT support

EXPERIMENTAL

Behavioral: Group counseling; Behavioral: Persuasive ICT support

Intensive group counseling

ACTIVE COMPARATOR

Behavioral: Intensive group counseling

Intensive group counseling + persuasive ICT support

EXPERIMENTAL

Behavioral: Intensive group counseling; Behavioral: Persuasive ICT support

Interventions

Group counseling BEHAVIORAL

4 times

Group counseling; Group counseling + persuasive ICT support

Intensive group counseling BEHAVIORAL

14 times

Intensive group counseling; Intensive group counseling + persuasive ICT support

Persuasive ICT support BEHAVIORAL

Weekly reminders for 12 months

Group counseling + persuasive ICT support; Intensive group counseling + persuasive ICT support

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Untreated hypothyroidism
• Oral corticosteroid treatment
• Pregnancy and lactation
• Angina pectoris
• Cardiac insufficiency
• Coronary Heart Disease
• Inability to speak Finnish
• Anticipated lack of compliance

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University Hospital

Oulu, 90029 OYS, Finland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Janne Hukkanen, MD, PhD

  University of Oulu, Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 11, 2020
• Study Start: June 2, 2020
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)