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Lifestyle intervention trial: a multidisciplinary lifestyle modification programme

A randomised controlled trial of a multidisciplinary lifestyle modification programme to improve risk factors for stroke and cardiovascular disease in the short- and long-term

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79355192
Enrollment
2083
Registered
2009-05-07
Start date
1994-08-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk factors for stroke and cardiovascular disease Circulatory System Complications and ill-defined descriptions of heart disease

Interventions

The education and rehabilitation program at Vindeln Health Centra (VHE-centre) has recently been described. A problem-based learning perspective was established and the responsibility of planning and

Sponsors

Umeå University (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All ages and both men and women 2. Remittance from primary health care or hospital doctors to target the components of a healthy lifestyle. The patients admitted to the centre in groups of 30 for a comprehensive activity 3. Able to take part in a four week long and organised program 4. The randomisation was performed after the inclusion of participants which eliminated the risk of selection bias. The outcomes from the intervention were assessed at baseline, after four weeks, sixth month and 11/2 year or one year and five years by the health care staff. 5. Sixty-four percent of the patients were hypertensive, 20% had type 2 diabetes mellitus, and 55% had a body mass index (BMI) greater than 30. In addition to the main diagnosis, around 50% had a second subsidiary diagnosis and exhibited a high number of risk factors associated with the insulin resistance syndrome.

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
1. Survival analysis and ECG recordings 2. Dietary assessments before and after the four week intervention 3. Baseline to follow up after 6 months, 1 or 11/2 years and 5 years for stroke and CVD risk factors 4. Weight loss and improved VO2-max

Secondary

MeasureTime frame
1. Changes in risk factor levels including weight loss and all-cause and CVD mortality over short and long term 2. ECG-changes, with MI-signs calculations at baseline and after 5 years 3. Food selections at admittance and at one year follow up registered by a questionnaire developed for this study 4. Psycho-social status and stress related health behaviour evaluation from questionnaires 5. Death certificates to assure diagnosis related risk factor changes

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026