Lifestyle Intervention in Primary Health Care - the Björknäs Study

NCT00486941 | Completed Phase 3

• 1 other identifier: EPN-Umea 02-512
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension; Type 2 Diabetes; Obesity; Dyslipidemia

Keywords

Primary Prevention; Health Promotion; Diet; Exercise; Risk Factors; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Blood pressure

  3 years

• Total cholesterol, HDL and triglycerides

  3 years

• Glucose tolerance (OGTT)

  3 years

Interventions

Exercise and diet - based on DPS and DPP BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from one single health care centre with a diagnosis of:
• Typ 2 diabetes,
• Hypertension,
• Obesity or
• Dyslipidemia

You may not qualify if:

• Coronary heart
• Disease,
• Stroke,
• TIA,
• BP \>180/105,
• Dementia; or
• Severe psychiatric disease

Sponsors & Collaborators

• Umeå University: lead
• County Council of Norrbotten, Sweden: collaborator

Study Sites (1)

Björknäs Health Centre

Boden, SE-96164, Sweden

Location

Related Publications (3)

• 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.

  PMID: 16990155 RESULT

• 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.

  PMID: 20837834 DERIVED

• 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.

  PMID: 19365563 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2; Obesity; Dyslipidemias; Motor Activity

Interventions

Exercise; dentin sialophosphoprotein

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mats CE Eliasson, MD, PhD

  Umeå University, Umeå, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2007
• First Posted: June 15, 2007
• Study Start: February 1, 2003
• Study Completion: March 1, 2006
• Last Updated: July 20, 2007

Record last verified: 2007-07

Locations

SE (1)