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Table 1 SMILE measurements, instruments and data collection schedule

From: Cost-effectiveness of a lifestyle intervention for people with a serious mental illness (SMILE): design of a pragmatic cluster-randomised controlled trial

  Baseline 3 month 6 month 12 month
PRIMARY
Weight loss (kg) x X x x
CLINICAL OUTCOMES
BMI (kg/m2) x X x x
Waist circumference (cm) x X x x
Lipid profiles* x    x
Glucose metabolism (mmol/l) x    x
Systolic BP (mm/hg) x   x x
Diastolic BP (mm/hg) x   x x
PATIENT REPORTS
Quality of life (SF12 and EQ-5D-5 L) x   x x
Health related self-efficacy (PAM-13) x   x x
Self-reported views on physical activity, nutrition status and sleep x   x x
Smoking status x   x x
DEMOGRAPHICS
Age, gender, ethnicity x    
Education level x    
Marital status x    x
Employment status x    x
Diagnosis of SMI x    
Number of years receiving ambulatory mental care x    
COSTS
Health care utilization and lost productivity questionnaire x   x x
Medication use x   x x
OTHER
Compliance to group sessions Weekly /monthly
  1. *Lipid profiles include fasting cholesterol (HDL, LDL, total) and fasting triglycerides (mmol/l)