Table 1 Study measures and data collection time periods

Socio-demographics/Lifestyle

Patient Interview

Age, sex, ethnicity, current marital status, highest level of education, occupation, current employment status, current household income level, smoking status (current, past, never)

Pre-surgery

Anthropometric

Standardized Case Report Form

Weight¹, height², BMI³

Pre-surgery, 3, 6, 12, 18, 24 months and annually thereafter

Medical History/Self-reported baseline comorbid conditions

Standardized Case Report Form

Diabetes, hypertension, dyslipidemia, sleep apnea, NAFLD, PCOS, etc.

Pre-surgery

Assessment of obesity-related comorbid conditions to evaluate changes in comorbid status

Standardized Case Report Form

Patient Interview

Diabetes, hypertension, dyslipidemia, NAFLD, PCOS

3, 6, 12, 18, 24 months and annually thereafter

PCOS will be assessed at 12 months only

Medication use

Standardized Case Report Form

Prescribed and over-the-counter medications (name, type, dosage, frequency and duration)

Pre-surgery, 3, 6, 12, 18, 24 months and annually thereafter

Clinical characteristics

Standardized Case Report Form

Blood pressure⁴, heart rate

Pre-surgery, 3, 6, 12, 18, 24 months and annually thereafter

Laboratory values

Meditech laboratory module

HbA1c, fasting blood glucose, insulin level, creatinine, fasting lipid panel (including total cholesterol, LDL, HDL, triglycerides), high sensitivity (hs) CRP, GGT, albumin, total bilirubin, ALP, ALT, total protein, ferritin, hemoglobin, MCV, TSH, 25-OH D, Vitamin B12

Pre-surgery, 3, 6, 12, 18, 24 months and annually thereafter

Health-related QoL

Validated surveys

SF 12v2, EQ‐5D, IWQoL‐Lite

Pre-surgery, 6, 12, 18, 24 months

Operative data

Clinical database and chart review

Minor and major complications

During surgery and up to 30 days post-surgery