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Lifestyle Intervention in Primary Health Care - the Björknäs Study

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00486941
Enrollment
151
Registered
2007-06-15
Start date
2003-02-28
Completion date
2006-03-31
Last updated
2007-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Hypertension, Obesity, Type 2 Diabetes

Keywords

Primary Prevention, Health Promotion, Diet, Exercise, Risk Factors, Randomized Controlled Trial

Brief summary

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

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

Interventions

BEHAVIORALExercise and diet - based on DPS and DPP

Sponsors

County Council of Norrbotten, Sweden
CollaboratorOTHER_GOV
Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in anthropometry (BMI, waist and hip cf)3 years
Maximal oxygen uptake (VO2max)3 years
Health-related quality of life (EQ 5D, SF-36)3 years
Self-reported physical activity3 years

Secondary

MeasureTime frame
Total cholesterol, HDL and triglycerides3 years
Glucose tolerance (OGTT)3 years
Blood pressure3 years

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026