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Clinical Trials/NCT03681002
NCT03681002
Completed
Not Applicable

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.

Uppsala University0 sites450 target enrollmentOctober 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Risk Factor
Sponsor
Uppsala University
Enrollment
450
Primary Endpoint
Change in physical activity
Status
Completed
Last Updated
7 years ago

Overview

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".

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
October 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with
  • hypertension
  • diabetes mellitus type 2
  • impaired glucose tolerance

Exclusion Criteria

  • severe psychiatric disease
  • difficulties to understand Swedish

Outcomes

Primary Outcomes

Change in physical activity

Time Frame: From baseline to 12 months

Patients rating perceived physical activity on a scale 0-10 at baseline and at 12 months

Secondary Outcomes

  • Framingham risk score(From baseline to 12 months)

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