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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2014

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".

Interventions

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

Arms, Groups and Cohorts

  • Other: structured lifestyle program
    • individual counseling focusing on Lifestyle habits

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Framingham risk score
    • Time Frame: From baseline to 12 months
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

Patients diagnosed with

  • hypertension – diabetes mellitus type 2 – impaired glucose tolerance Exclusion Criteria:

  • dementia – severe psychiatric disease – difficulties to understand Swedish

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Uppsala University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mattias K Damberg, Principal Investigator, Associate professor, Department of Public health and caring sciences; Family medicine and preventive medicin

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