Lifestyle Intervention in Primary Health Care - the Björknäs Study
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Type 2 Diabetes Obesity Dyslipidemia |
Behavioral: Exercise and diet - based on DPS and DPP |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomized Trial of Lifestyle Intervention in Primary Health Care for the Modification of Cardiovascular Risk Factors - the Björknäs Study |
- Changes in anthropometry (BMI, waist and hip cf) [ Time Frame: 3 years ]
- Maximal oxygen uptake (VO2max) [ Time Frame: 3 years ]
- Health-related quality of life (EQ 5D, SF-36) [ Time Frame: 3 years ]
- Self-reported physical activity [ Time Frame: 3 years ]
- Blood pressure [ Time Frame: 3 years ]
- Total cholesterol, HDL and triglycerides [ Time Frame: 3 years ]
- Glucose tolerance (OGTT) [ Time Frame: 3 years ]
| Enrollment: | 151 |
| Study Start Date: | February 2003 |
| Study Completion Date: | March 2006 |
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
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Sweden | |
| Björknäs Health Centre | |
| Boden, Sweden, SE-96164 | |
| Principal Investigator: | Mats CE Eliasson, MD, PhD | Umeå University, Umeå, Sweden |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00486941 History of Changes |
| Other Study ID Numbers: | EPN-Umea 02-512 |
| Study First Received: | June 14, 2007 |
| Last Updated: | July 18, 2007 |
| Health Authority: | Sweden: Institutional Review Board |
Keywords provided by Umeå University:
|
Primary Prevention Health Promotion Diet |
Exercise Risk Factors Randomized Controlled Trial |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 2 Hypertension Obesity Dyslipidemias Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Vascular Diseases Cardiovascular Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Lipid Metabolism Disorders |
ClinicalTrials.gov processed this record on June 13, 2013