Lifestyle Intervention in Primary Health Care - the Björknäs Study

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hypertension, Type 2 Diabetes, Obesity, Dyslipidemia

Intervention / Treatment
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* Behavioral: Exercise and diet - based on DPS and DPP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Exercise and diet - based on DPS and DPP|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 3 years | 
| Total cholesterol, HDL and triglycerides |  | 3 years | 
| Glucose tolerance (OGTT) |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Prevention, Health Promotion, Diet, Exercise, Risk Factors, Randomized Controlled Trial