Implementation of a Structured Lifestyle Program in Primary Care. Changes in Lifestyle Habits and Cardiovascular Risk.

NCT ID: NCT03681002

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2014-10-31

Brief Summary

The aim of the present study is to describe and evaluate the effect of a structured lifestyle intervention program, focusing on lifestyle habits, in a primary care setting in patients with high cardiovascular risk. Furthermore, we want to explore the patient´s experience of lifestyle change and counseling after participation in the intervention program and to investigate the cost-effectiveness of the program.

Detailed Description

Intervention The intervention program comprises five individual visits to the same nurse, specialised in diabetes care and the metabolic syndrome every three month during one year. The nurse led a person centered dialog based on the answers from a questionnaire. At every visit, focus was primarily on lifestyle habits, using motivational interviewing to strengthen the patient's ability to modify one or more lifestyle habits. Dietary counselling was in accordance with the Swedish recommendation in nutrition. If the patient were in need of extended counseling regarding one or more lifestyle habits, he or she could be referred within the primary care unit to a specialist. During the 12-month period, all patients where offered to participate in evening group sessions at three different occasions. Topics were physical activity, fatty acids, healthy food, tobacco and alcohol, stress, sleep and methods of how to change behavior".

Conditions

Cardiovascular Risk Factor; Lifestyle Risk Reduction; Primary Care

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

structured lifestyle program

individual counseling focusing on Lifestyle habits

Group Type: OTHER

structured lifestyle program

Intervention Type: BEHAVIORAL

Intensive Lifestyle counseling during one year

Interventions

structured lifestyle program

Intensive Lifestyle counseling during one year

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Patients diagnosed with

• hypertension
• diabetes mellitus type 2
• impaired glucose tolerance

Exclusion Criteria

• dementia
• severe psychiatric disease
• difficulties to understand Swedish

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mattias K Damberg

Role: PRINCIPAL_INVESTIGATOR

Associate professor, Department of Public health and caring sciences; Family medicine and preventive medicin

Other Identifiers

DNR 2014/ 497

Identifier Type: -

Identifier Source: org_study_id