Health Coaching to Promote Physical Activity for Coronary Heart Disease Prevention

NCT ID: NCT01089842

Last Updated: 2010-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-01-31

Brief Summary

The purpose of this study is to evaluate the efficacy of motivational interviewing-based coaching to increase physical activity to achieve guidelines recommendations for cardiovascular disease prevention.

Detailed Description

Cardiovascular diseases are the main cause of death in developed countries. Epidemiological studies have shown that a sedentary lifestyle is associated with an increased risk of cardiovascular diseases, mainly related to classical risk factors (obesity, diabetes, hypertension). International guidelines recommend, because of that, a minimum of 30 minutes per day at least 5 days per week of moderate physical activity for primary and secondary cardiovascular disease prevention.

Physical inactivity is an increasing public health problem in developed countries. It is known that clinical advice has a poor efficacy to increase levels of physical activity on individuals and new strategies need to be developed.

Coaching is a strategy of personal help that is being widely and successfully used in business world. It consists of an structured and individualized process of assistance to people to promote cognitive changes needed to achieve behavioural changes. It can be a complementary method to information and sanitary education emphasizing on consciousness and responsibility of the patient and is now starting to be used in medical practice. The purpose of the study is to define usefulness of an strategy based on coaching techniques to promote physical activity practice and healthy lifestyle on individuals with known coronary heart disease or cardiovascular risk factors.

Conditions

Coronary Disease; Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Health coaching

Group Type: EXPERIMENTAL

Health coaching

Intervention Type: BEHAVIORAL

Coaching based advice will be performed by previously trained nurses. Intervention will be directed to increase physical activity to achieve levels recommended on guidelines. Patients will receive one session per month during 6 months. Time for each session is estimated on 10 to 20 minutes. Sessions will be mostly carried out by phone, although physical attendance or internet services can also be used.

Control

Group Type: NO_INTERVENTION

Usual care

Intervention Type: OTHER

Patients on control group will receive usual assistance, including physical activity counselling by their treating physician.

Interventions

Health coaching

Coaching based advice will be performed by previously trained nurses. Intervention will be directed to increase physical activity to achieve levels recommended on guidelines. Patients will receive one session per month during 6 months. Time for each session is estimated on 10 to 20 minutes. Sessions will be mostly carried out by phone, although physical attendance or internet services can also be used.

Intervention Type: BEHAVIORAL

Usual care

Patients on control group will receive usual assistance, including physical activity counselling by their treating physician.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients wiht coronary risk factors or known ischaemic heart disease defined as sedentary (<600MET-min/week).

Exclusion Criteria

• Bundle branch block or pacemaker rhythm
• Limitation or contraindication to moderate physical activity (fast walking)
• Unstable clinical situation
• Communication difficulties due to language or sensorial deficiencies.
• Lack of informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Corporacion Parc Tauli

Principal Investigators

Joan R Guma

Role: PRINCIPAL_INVESTIGATOR

Corporacion Parc Tauli

Locations

Hospital de Sabadell

Sabadell, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Joan R Guma

Role: CONTACT

jgumag@gmail.com

0034937231010

Other Identifiers

CIR08/034

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI08/90182

Identifier Type: -

Identifier Source: org_study_id