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Lifestyle Intervention in Primary Health Care - the Björknäs Study

Primary Purpose

Hypertension, Type 2 Diabetes, Obesity

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Exercise and diet - based on DPS and DPP
Sponsored by
Umeå University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Primary Prevention, Health Promotion, Diet, Exercise, Risk Factors, Randomized Controlled Trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Björknäs Health Centre

Outcomes

Primary Outcome Measures

Changes in anthropometry (BMI, waist and hip cf)
Maximal oxygen uptake (VO2max)
Health-related quality of life (EQ 5D, SF-36)
Self-reported physical activity

Secondary Outcome Measures

Blood pressure
Total cholesterol, HDL and triglycerides
Glucose tolerance (OGTT)

Full Information

First Posted
June 14, 2007
Last Updated
July 18, 2007
Sponsor
Umeå University
Collaborators
County Council of Norrbotten, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT00486941
Brief Title
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

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Umeå University
Collaborators
County Council of Norrbotten, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Type 2 Diabetes, Obesity, Dyslipidemia
Keywords
Primary Prevention, Health Promotion, Diet, Exercise, Risk Factors, Randomized Controlled Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Exercise and diet - based on DPS and DPP
Primary Outcome Measure Information:
Title
Changes in anthropometry (BMI, waist and hip cf)
Time Frame
3 years
Title
Maximal oxygen uptake (VO2max)
Time Frame
3 years
Title
Health-related quality of life (EQ 5D, SF-36)
Time Frame
3 years
Title
Self-reported physical activity
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
3 years
Title
Total cholesterol, HDL and triglycerides
Time Frame
3 years
Title
Glucose tolerance (OGTT)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats CE Eliasson, MD, PhD
Organizational Affiliation
Umeå University, Umeå, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Björknäs Health Centre
City
Boden
ZIP/Postal Code
SE-96164
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
16990155
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.
Results Reference
result
PubMed Identifier
20837834
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.
Results Reference
derived
PubMed Identifier
19365563
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.
Results Reference
derived

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Lifestyle Intervention in Primary Health Care - the Björknäs Study

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