Lifestyle Intervention in Primary Health Care - the Björknäs Study

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486941
• Other study ID #: EPN-Umea 02-512
• 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
• 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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension
• Obesity
• Type 2 Diabetes

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