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Lifestyle Intervention in Primary Health Care - the Björknäs Study

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ClinicalTrials.gov Identifier: NCT00486941
Recruitment Status : Completed
First Posted : June 15, 2007
Last Update Posted : July 20, 2007
County Council of Norrbotten, Sweden
Information provided by:
Umeå University

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

Condition or disease Intervention/treatment Phase
Hypertension Type 2 Diabetes Obesity Dyslipidemia Behavioral: Exercise and diet - based on DPS and DPP Phase 3

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  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Lifestyle Intervention in Primary Health Care for the Modification of Cardiovascular Risk Factors - the Björknäs Study
Study Start Date : February 2003
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 3 years ]
  2. Total cholesterol, HDL and triglycerides [ Time Frame: 3 years ]
  3. Glucose tolerance (OGTT) [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486941

Björknäs Health Centre
Boden, Sweden, SE-96164
Sponsors and Collaborators
Umeå University
County Council of Norrbotten, Sweden
Principal Investigator: Mats CE Eliasson, MD, PhD Umeå University, Umeå, Sweden