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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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
-
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.
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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.
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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.
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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.