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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00486941
Other study ID # EPN-Umea 02-512
Secondary ID
Status Completed
Phase Phase 3
First received June 14, 2007
Last updated July 18, 2007
Start date February 2003
Est. completion date March 2006

Study information

Verified date July 2007
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority Sweden: Institutional Review Board
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 151
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
Exercise and diet - based on DPS and DPP


Locations

Country Name City State
Sweden Björknäs Health Centre Boden

Sponsors (2)

Lead Sponsor Collaborator
Umeå University County Council of Norrbotten, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in anthropometry (BMI, waist and hip cf) 3 years
Primary Maximal oxygen uptake (VO2max) 3 years
Primary Health-related quality of life (EQ 5D, SF-36) 3 years
Primary Self-reported physical activity 3 years
Secondary Blood pressure 3 years
Secondary Total cholesterol, HDL and triglycerides 3 years
Secondary Glucose tolerance (OGTT) 3 years
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