Lifestyle Intervention in Primary Health Care - the Björknäs Study

July 18, 2007 updated by: Umeå University

A Randomized Trial of Lifestyle Intervention in Primary Health Care for the Modification of Cardiovascular Risk Factors - the Björknäs Study

The purpose of this study is to determine whether a short group intervention programe aiming at lifestyle changes at a local health centre can improve risk factors for cardiovascular disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: Exercise and diet - based on DPS and DPP

Detailed Description

Successfully transferring the findings of expensive and tightly controlled lifestyle intervention programmes to the primary care setting is necessary if such knowledge is to be used for disease prevention at the population level. Therefore, our objective was to evaluate the efficacy of a lifestyle intervention programe in the primary health care setting, targeted at patients with moderate- to high-risk of cardiovascular disease according to cardiovascular risk factor levels, physical activity and quality of life ratings.

Randomised controlled trial with follow-up at 3, 12, 24 and 36 months, carried out in a primary health care centre in Northern Sweden. A total of 151 middle-aged men and women, with hypertension, dyslipidemia, type 2 diabetes or obesity were enrolled. The subjects were randomised to an intervention (n = 75) or control group (n = 76). 120 subjects completed the three-year follow-up. The intervention was based on the protocols used in the Finnish Diabetes Prevention study (DPS) and the U.S Diabetes Prevention Program

Study Type

Interventional

Enrollment (Actual)

151

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Sweden
- - Boden, Sweden, SE-96164
    - Björknäs Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients from one single health care centre with a diagnosis of:
- Typ 2 diabetes,
- Hypertension,
- Obesity or
- Dyslipidemia

Exclusion Criteria:

Coronary heart
Disease,
Stroke,
TIA,
BP >180/105,
Dementia; or
Severe psychiatric disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in anthropometry (BMI, waist and hip cf) Time Frame: 3 years	3 years
Maximal oxygen uptake (VO2max) Time Frame: 3 years	3 years
Health-related quality of life (EQ 5D, SF-36) Time Frame: 3 years	3 years
Self-reported physical activity Time Frame: 3 years	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood pressure Time Frame: 3 years	3 years
Total cholesterol, HDL and triglycerides Time Frame: 3 years	3 years
Glucose tolerance (OGTT) Time Frame: 3 years	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

County Council of Norrbotten, Sweden

Investigators

Principal Investigator: Mats CE Eliasson, MD, PhD, Umea University, Umea, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

June 14, 2007

First Submitted That Met QC Criteria