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

Not Applicable

Completed

• Conditions: Lifestyle Risk Reduction; Cardiovascular Risk Factor; Primary Care
• Interventions: Behavioral: structured lifestyle program

• Registration Number: NCT03681002
• Lead Sponsor: Uppsala University

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".

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2018-09
• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-20
• Last Update Submitted: 2018-09-20
• Study First Posted: 2018-09-21
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
structured lifestyle program	structured lifestyle program	individual counseling focusing on Lifestyle habits

Primary Outcome Measures

Name	Time	Method
Change in physical activity	From baseline to 12 months	Patients rating perceived physical activity on a scale 0-10 at baseline and at 12 months

Secondary Outcome Measures

Name	Time	Method
Framingham risk score	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.