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Lifestyle Intervention in Primary Health Care - the Björknäs Study

This study has been completed.
Sponsor:
Collaborator:
County Council of Norrbotten, Sweden
Information provided by:
Umeå University
ClinicalTrials.gov Identifier:
NCT00486941
First received: June 14, 2007
Last updated: July 18, 2007
Last verified: July 2007
History of Changes

June 14, 2007
July 18, 2007
February 2003
Not Provided
  • Changes in anthropometry (BMI, waist and hip cf) [ Time Frame: 3 years ]
  • Maximal oxygen uptake (VO2max) [ Time Frame: 3 years ]
  • Health-related quality of life (EQ 5D, SF-36) [ Time Frame: 3 years ]
  • Self-reported physical activity [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT00486941 on ClinicalTrials.gov Archive Site
  • Blood pressure [ Time Frame: 3 years ]
  • Total cholesterol, HDL and triglycerides [ Time Frame: 3 years ]
  • Glucose tolerance (OGTT) [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
 
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

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

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hypertension
  • Type 2 Diabetes
  • Obesity
  • Dyslipidemia
Behavioral: Exercise and diet - based on DPS and DPP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
March 2006
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00486941
EPN-Umea 02-512
No
Not Provided
Umeå University
County Council of Norrbotten, Sweden
Principal Investigator: Mats CE Eliasson, MD, PhD Umeå University, Umeå, Sweden
Umeå University
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP