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Table 1 Key measures and instruments

From: Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial

Key Measures Instruments Notes
Body weight and composition TANITA scales BC420MA Body weight, and bioimpedance for body composition.
Height Stadiometer SECA 123  
HbA1c Turbidimetric inhibition immunoassay for haemolysed whole blood in ROCHE COBAS 6000c Module Measured at a central laboratory.
Continuous Glucose Monitoring iPro2 Professional CGM system (Medtronic MiniMed) Continuous glucose monitoring system (CGMS) will be used for 7 consecutive days.
Quality of Life 1. EQ-5D-5 L
2. IWQOL-LITE
1. EQ-5D-5 L comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
2. Impact of Weight on Quality Of Life-Lite (IWQOL-Lite) is a validated 31-item, self-report measure of obesity-specific quality of life. In addition to a total score, there are scores on five domains: physical function; self-esteem; sexual life; public distress; work.
Mental Health HADS The Hospital Anxiety and Depression Scale (HADS) comprises 14 items, 7 for anxiety, and 7 for depression. The scale yields individual anxiety and depression scores as well as an overall HADS score.
Physical Activity 1. IPAQ
2. SIT-Q-7D
3. ActiGraph GT3X
1. The International Physical Activity Questionnaire (IPAQ) comprises of seven questions recalling the previous week’s physical activity falling into four different physical activity domains: leisure-time activities, domestic and gardening activities, work-related activities, and transportation.
2. The Sedentary Behaviour Questionnaire (SIT-Q-7d) is a self-report recall measure of sedentariness over the last seven days. It assesses total daily sedentary time as an aggregate of sitting/lying down in five domains (meals, transportation, occupation, non-occupational screen time, and other sedentary time).
3. The ActiGraph GT3X is a wrist-worn activity monitor that uses triaxial accelerometry to collect physical activity and sleep data. Accerometry will be carried out over 7 consecutive days.
Energy Expenditure Indirect calorimetry (Cosmed Fitmate GS) Portable desktop indirect calorimeter for measurement of Resting Metabolic Rate (RMR)
Liver transient elastography EchoSens Fibroscan 502 Touch Non-invasive elastography device which gives 50 Hz shear wave speed measurements and estimates of liver stiffness as well as 3.5 MHz ultrasound coefficient of attenuation.