Condition category
Circulatory System
Date applied
17/02/2009
Date assigned
07/05/2009
Last edited
07/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lena Håglin

ORCID ID

Contact details

Department of Public Health and Clinical Medicine
Family Medicine
Umeå University
Umeå
90185
Sweden
lena.haglin@vll.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

VHC-intervention

Study hypothesis

1. A four week, life-style intervention program will improve risk factors for stroke and cardiovascular disease in the short- and long-term
2. A healthy diet and increased physical activity in addition to stress handling will increase survival in the long-term
3. The participants will have positive experiences from the individual guidance and the intervention which in turn will reduce morbidity and mortality risk by decreasing risk factor patterns

Ethics approval

The Ethics Committee of the Medical Faculty of Umeå University gave approval on the 22nd November 2006 (ref: 05-177M)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Risk factors for stroke and cardiovascular disease

Intervention

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 execution of the activities was shared between patients and the staff, consisting of a doctor, nurse, physiotherapists, dietician, and other important supporters.

In total, 114 full-time hours, focusing on food preferences, selections, physical exercise, and stress management were provided during the first four weeks. The activities were repeated during a four-day revisit to the centre 6 or 12 months after the program. The study tried to establish functioning groups as a source to achieve changes and as a start for individual targets. The main focus was to combat risk of future stroke and CVD. The refresher course was used for repetition and revision of the "home program".

The randomised study took advantage of a mismatch between demands and supply of the multidisciplinary programme. Referrals from the county accumulated during the 4 - 6 weeks preceding the admittance dates. Proper referrals were determined by the team doctor and the clinical team at the centre. During seven rounds of admission in 1988 - 1989, 325 patients were properly referred to the programme. They outnumbered the available places. It was not feasible, with available knowledge, to rank the needs for this treatment by the type of risk factor or by the risk factor levels. Instead patients were listed with identity numbers (not names or referral forms) and the list was sent to one researcher (Thomas Svensson) who allocated the cases using random numbers. When a patient allocated to treatment announced that he or she was prevented from coming, one more patient from the full list was randomised to be a case. Eventually 239 patients were randomly allocated to the programme, and 86 patients referred back to their doctor for usual care.

Signs of myocardial infarction (MI) and left ventricular hypertrophy (LVH) are important to include in the study of risk factors for CVD. Other pathological features were also noted (particularly if they had changed during the study period). A previous MI was diagnosed when, at the beginning of the study, there were electrocardiogram (ECG) signs corresponding to the Minnesota Code criteria: 1:1-2, 5:1-2, and 1:3+5:3, MI (ECGsp), coded as 2, and if less specific ECG criteria were found corresponding to Minnesota code 1:3, 5:3, 6:1-4, 7:1-3, 8:0-9, and 9:1-8 MI (ECGnonsp) coded as 1.

The occurrence of signs of a new MI during the study period, i.e, during a period of on average 5 years, as observed from the ECG recording at the end of the study, was diagnosed as a recent MI (ECGsp or ECGnonsp).

Changes in ECG signs after (A) compared with before (B) the intervention were obtained by subtracting the code values (B - A), resulting in a scale with the steps -2, -1, 0, 1, or 2. A negative value denotes diminishing and a positive value signs of a new or increasing signs of previous MI.

LVH was diagnosed when there was a high amplitude QRS complex, Minnesota Code criteria 3:1 and 3:3, or in combination with typical ST and T changes as in Minnesota Code criteria 4:1-4.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/08/1994

Overall trial end date

01/12/1996

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

2083 patients (1180 women and 903 men)

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/08/1994

Recruitment end date

01/12/1996

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Public Health and Clinical Medicine, Family Medicine
Umeå
90185
Sweden

Sponsor information

Organisation

Umeå University (Sweden)

Sponsor details

Department of Family Medicine
Department of Public Health and Clinical Medicine
University Hospital
Umeå
90185
Sweden
brittinger.hogberg@vll.se

Sponsor type

University/education

Website

http://www.umu.se

Funders

Funder type

Government

Funder name

County Council of Västerbotten (Västerbottens läns landsting [VLL]) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 1999 principles of learning results: http://www.ncbi.nlm.nih.gov/pubmed/10406442
2. 2001 gender difference results: http://www.ncbi.nlm.nih.gov/pubmed/11423926
3. 2006 outcome results: http://www.ncbi.nlm.nih.gov/pubmed/16139982
4. 2007 mortality results: http://www.ncbi.nlm.nih.gov/pubmed/17721752

Publication citations

  1. Principles of learning results

    Sjöström M, Karlsson AB, Kaati G, Yngve A, Green LW, Bygren LO, A four week residential program for primary health care patients to control obesity and related heart risk factors: effective application of principles of learning and lifestyle change., Eur J Clin Nutr, 1999, 53 Suppl 2, S72-7.

  2. Gender difference results

    Håglin L, Lindblad A, Bygren LO, Hypophosphataemia in the metabolic syndrome. Gender differences in body weight and blood glucose., Eur J Clin Nutr, 2001, 55, 6, 493-498, doi: 10.1038/sj.ejcn.1601209.

  3. Outcome results

    Kaati G, Bygren LO, Vester M, Karlsson A, Sjöström M, Outcomes of comprehensive lifestyle modification in inpatient setting., Patient Educ Couns, 2006, 62, 1, 95-103, doi: 10.1016/j.pec.2005.06.012.

  4. Mortality results

    Håglin L, Törnkvist B, Bäckman L, Prediction of all-cause mortality in a patient population with hypertension and type 2 DM by using traditional risk factors and serum-phosphate,-calcium and-magnesium., Acta Diabetol, 2007, 44, 3, 138-143, doi: 10.1007/s00592-007-0254-6.

Additional files

Editorial Notes