Lifestyle intervention trial: a multidisciplinary lifestyle modification programme

ISRCTN	ISRCTN79355192
DOI	https://doi.org/10.1186/ISRCTN79355192
Secondary identifying numbers	N/A

Submission date: 17/02/2009
Registration date: 07/05/2009
Last edited: 07/05/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lena Håglin
Scientific

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

Email	lena.haglin@vll.se

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Study acronym	VHC-intervention
Study objectives	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(s)	The Ethics Committee of the Medical Faculty of Umeå University gave approval on the 22nd November 2006 (ref: 05-177M)
Health condition(s) or problem(s) studied	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
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 study start date	01/08/1994
Completion date	01/12/1996

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	2083 patients (1180 women and 903 men)
Key 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.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/08/1994
Date of final enrolment	01/12/1996

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Public Health and Clinical Medicine, Family Medicine

Umeå
90185
Sweden

Sponsor information

Umeå University (Sweden)
University/education

Department of Family Medicine
Department of Public Health and Clinical Medicine
University Hospital
Umeå
90185
Sweden

Email	brittinger.hogberg@vll.se
Website	http://www.umu.se
"ROR"	https://ror.org/05kb8h459

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	principles of learning results:	01/05/1999	Yes	No
Results article	gender difference results:	01/06/2001	Yes	No
Results article	outcome results:	01/07/2006	Yes	No
Results article	mortality results:	01/09/2007	Yes	No