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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04425304

Enrollment

200

Registered

2020-06-11

Start date

2020-06-02

Completion date

2024-05-23

Last updated

2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

BEHAVIORALPersuasive ICT support

Weekly reminders for 12 months

BEHAVIORALGroup counseling

4 times

BEHAVIORALIntensive group counseling

14 times

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Change in body weight	Baseline to 2 years

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026