Lifestyle Intervention in Primary Health Care - the Björknäs Study

Phase 3

Completed

• Conditions: Hypertension; Dyslipidemia; Obesity; Type 2 Diabetes

• Registration Number: NCT00486941
• Lead Sponsor: 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

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 Timeline

• Study Start: 2003-02
• Study Completion: 2006-03
• Study First Submitted: 2007-06-14
• Study First Submitted QC: 2007-06-14
• Study First Posted: 2007-06-15
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-18
• Last Update Posted: 2007-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 activity	3 years

Secondary Outcome Measures

Name	Time	Method
Total cholesterol, HDL and triglycerides	3 years
Glucose tolerance (OGTT)	3 years
Blood pressure	3 years

Trial Locations

Locations (1)

Björknäs Health Centre; 🇸🇪 Boden, Sweden