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Completed

NCT Number: NCT00486941

Lifestyle Intervention in Primary Health Care - the Björknäs Study

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

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Key information

Conditions

Hypertension Behavior Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Björknäs Health Centre

Boden, SE-96164, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise and diet - based on DPS and DPP

Behavioral

Primary outcomes

  1. Changes in anthropometry (BMI, waist and hip cf)

    Time frame: 3 years

  2. Maximal oxygen uptake (VO2max)

    Time frame: 3 years

  3. Health-related quality of life (EQ 5D, SF-36)

    Time frame: 3 years

  4. Self-reported physical activity

    Time frame: 3 years

Secondary outcomes

  1. Blood pressure

    Time frame: 3 years

  2. Total cholesterol, HDL and triglycerides

    Time frame: 3 years

  3. Glucose tolerance (OGTT)

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • County Council of Norrbotten, Sweden

Registry information

Official study title

A Randomized Trial of Lifestyle Intervention in Primary Health Care for the Modification of Cardiovascular Risk Factors - the Björknäs Study

Important dates

Study start
2003
Study completion
2006
First posted
Jun 15, 2007
Registry last updated
Jul 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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