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

Sponsor

University of Oulu (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04425304

Collaborator

(none)

200

Enrollment

Location

Arms

30.9

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Group counseling Behavioral: Intensive group counseling Behavioral: Persuasive ICT support	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 2, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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: Intensive group counseling 14 times Behavioral: Persuasive ICT support Weekly reminders for 12 months

Outcome Measures

Primary Outcome Measures

Change in body weight [Baseline to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oulu University Hospital	Oulu		Finland	90029 OYS

Sponsors and Collaborators

University of Oulu

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janne Hukkanen, Professor of Internal Medicine, University of Oulu

ClinicalTrials.gov Identifier:

NCT04425304

Other Study ID Numbers:

Resepti-Onnikka

First Posted:

Jun 11, 2020

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of May 17, 2022