A Randomized Trial of Lifestyle Intervention in Primary Health Care for the Modification of Cardiovascular Risk Factors - the Björknäs Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Umeå University
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- Maximal oxygen uptake (VO2max)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
- •BP >180/105,
- •Dementia; or
- •Severe psychiatric disease
Outcomes
Primary Outcomes
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
Changes in anthropometry (BMI, waist and hip cf)
Time Frame: 3 years
Secondary Outcomes
- Total cholesterol, HDL and triglycerides(3 years)
- Glucose tolerance (OGTT)(3 years)
- Blood pressure(3 years)