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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03681002
Other study ID # DNR 2014/ 497
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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