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

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.

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Key information

Conditions

Cardiovascular Risk Factor Behavior Lifestyle Risk Reduction Primary Care Risk Reduction Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients diagnosed with

hypertension
diabetes mellitus type 2
impaired glucose tolerance

Exclusion criteria

dementia
severe psychiatric disease
difficulties to understand Swedish

Treatment and study plan

structured lifestyle program

Behavioral

Intensive Lifestyle counseling during one year

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

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.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study 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.

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Sep 21, 2018
Registry last updated: Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed