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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)