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
  Purpose

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 Intervention Phase
Hypertension
Type 2 Diabetes
Obesity
Dyslipidemia
Behavioral: Exercise and diet - based on DPS and DPP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 151
Study Start Date: February 2003
Study Completion Date: March 2006
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486941

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00486941     History of Changes
Other Study ID Numbers: EPN-Umea 02-512
Study First Received: June 14, 2007
Last Updated: July 18, 2007
Health Authority: Sweden: Institutional Review Board

Keywords provided by Umeå University:
Primary Prevention
Health Promotion
Diet
Exercise
Risk Factors
Randomized Controlled Trial

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus, Type 2
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 18, 2014