The intervention was a 6 week intensive, tailored, educational program that included a motivational interview, smoking secession program, dietary and physical activity counselling, and patient education. The main outcome measures were substance-free days, time to relapse and treatment adherence assessed after 6 weeks and 12 months. Secondary outcomes were lifestyle factors, co-morbidity, and quality of life.
Variables
Risk factors
At inclusion the patients were screened for four riskfactors: smoking (daily smoking or daily use of snuff ), physical inactivity (being physical active less than 30 min per day ), overweight (BMI > 25.5 or waistmeasure >80 cm for women / >94 cm for men ) or underweight (BMI < 20.5 ).
Comorbidity
##heart, lung, diabetes or lever
and at least one of the following chronic health conditions: lung-, heart-, liver diseases and diabetes.
Other variables
## Education (three categories Low, medium and high), age (continious), sex, randomisation (Intervention or control), quality of life (SF-36)(high or low, cutoff at median), being treated for alcohol/drug addiction, number of comorbidities.
Analysis
Predictors for successful change of risk factor(s) was identified, and odds ratios (ORs) and 95% confidence intervals (95% CI) were estimated using logistic regression analyses. Initially univariate analyses were conducted testing the association between successful change of lifestyle and trial arm, age, sex, alcohol or drug treatment, number of comorbidities, substance free days, quality of life, level of education, number of riskfactors at baseline, respectively. Age was entered as a continious variable while all other variables were entered as categorical variables. Hereafter, the multivariable logistic regression analysis were fitted based on the initial analyses. The final model were adjusted for quality of life, number of risk factors and ###. Patients with missing data were excluded from the analysis.
In the initial univariate analyses a two-sided p-value <0.2 was used to identify factors of importance. In the final analysis a two-sided p-value <0.05 was considered statistically significant.
Ethical considerations
FROM ART 3: All the patients were informed about the procedure of the data collection and physical examinations before the written informed consent was given. Separate rooms were used to maintain the privacy during the interviews and examinations. Information was kept in the case report files, however, data requiring new / revised clinical intervention, such as untreated comorbidity or acute aggravation were passed to the treating physician according to the guidelines at the clinic.
The project was approved by the
Central Ethical Review Board (Dnr 2010/470) and the Swedish Data Protection Authority and registered in www.clinicaltrials.gov. The patients participated after giving informed consent, which could be withdrawn at any time without explanation or consequences for the usual treatment and care, and the new VIP intervention was compared to the treatment as usual.