Clinical trial NCT00486941: Lifestyle Intervention in Primary Health Care - the Björknäs Study
Official title: A Randomized Trial of Lifestyle Intervention in Primary Health Care for the Modification of Cardiovascular Risk Factors - the Björknäs Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Type 2 Diabetes
Obesity
Dyslipidemia
Keywords: Primary Prevention
Health Promotion
Diet
Exercise
Risk Factors
Randomized Controlled Trial
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: County Council of Norrbotten, Sweden
First posted: 2007-06-15
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: Changes in anthropometry (BMI, waist and hip cf)
timeFrame: 3 years
measure: Maximal oxygen uptake (VO2max)
timeFrame: 3 years
measure: Health-related quality of life (EQ 5D, SF-36)
timeFrame: 3 years
measure: Self-reported physical activity
timeFrame: 3 years
Secondary outcomes:
measure: Blood pressure
timeFrame: 3 years
measure: Total cholesterol, HDL and triglycerides
timeFrame: 3 years
measure: Glucose tolerance (OGTT)
timeFrame: 3 years
Other outcomes:
Locations:
city: Boden
country: Sweden
facility: Björknäs Health Centre
Study officials:
affiliation: Umeå University, Umeå, Sweden
name: Mats CE Eliasson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eriksson KM, Westborg CJ, Eliasson MC. A randomized trial of lifestyle intervention in primary healthcare for the modification of cardiovascular risk factors. Scand J Public Health. 2006;34(5):453-61. doi: 10.1080/14034940500489826.
citation: Eriksson MK, Hagberg L, Lindholm L, Malmgren-Olsson EB, Osterlind J, Eliasson M. Quality of life and cost-effectiveness of a 3-year trial of lifestyle intervention in primary health care. Arch Intern Med. 2010 Sep 13;170(16):1470-9. doi: 10.1001/archinternmed.2010.301.
citation: Eriksson MK, Franks PW, Eliasson M. A 3-year randomized trial of lifestyle intervention for cardiovascular risk reduction in the primary care setting: the Swedish Bjorknas study. PLoS One. 2009;4(4):e5195. doi: 10.1371/journal.pone.0005195. Epub 2009 Apr 14.