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

Cardiovascular Risk Factor Clinical Trial

Official title:

Implementation of a Structured Lifestyle Program in a Primary Care Setting. Changes in Lifestyle and Effects on Cardiovascular Risk in Patients With High Cardiovascular Risk.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681002
• Other study ID #: DNR 2014/ 497
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: October 2014

Study information

• Verified date: September 2018
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Patients diagnosed with

• hypertension

• diabetes mellitus type 2

• impaired glucose tolerance

Exclusion Criteria:

• dementia

• severe psychiatric disease

• difficulties to understand Swedish

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Lifestyle Risk Reduction
• Primary Care

Intervention

Behavioral:
• structured lifestyle program
Intensive Lifestyle counseling during one year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical activity	Patients rating perceived physical activity on a scale 0-10 at baseline and at 12 months	From baseline to 12 months
Secondary	Framingham risk score	The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. Cardiovascular risk scoring systems give an estimate of the probability that a person will develop cardiovascular disease within a specified amount of time, in this case 10 years. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.	From baseline to 12 months