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Lifestyle Intervention in Primary Health Care - the Björknäs Study

U

Umeå University

Status and phase

Completed
Phase 3

Conditions

Hypertension
Obesity
Dyslipidemia
Type 2 Diabetes

Treatments

Behavioral: Exercise and diet - based on DPS and DPP

Study type

Interventional

Funder types

Other

Identifiers

NCT00486941
EPN-Umea 02-512

Details and patient eligibility

About

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

Full 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

Enrollment

151 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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