|
Outcome | Definition and measurement | Timepoint measured |
Baseline | EOP | 1-year |
|
Primary outcome | | | | |
Fasting plasma glucose (FPG 0-hour) | Reduction in FPG (0-hour) on a 75 gram oral glucose tolerance test (OGTT) | ✓ | | ✓ |
Secondary outcomes | | | | |
Glucose tolerance (GT2 hour) | Reduction in postload glucose tolerance (2-hour) on a 75 gram OGTT | ✓ | | ✓ |
Insulin resistance (IR) | Reduction in IR as measured by Homeostasis Model Assessment (HOMA2- IR), using fasting glucose and insulin values [33] on a 75 gram OGTT | ✓ | | ✓ |
Lipid profile | (i) Reduction in triglycerides, LDL, and total cholesterol (ii) Improvement in HDL cholesterol | ✓ | ✓ | ✓ |
Diet adherence | Improvement in overall Mediterranean Diet Score, a composite diet index based on the traditional Mediterranean dietary pattern [34] | ✓ | ✓ | ✓ |
Weight and shape | (i) Reduction in weight (kilograms) (ii) Reduction in waist circumference (CM) | ✓ | ✓ | ✓ |
Physical activity and fitness | (i) Total exercise per week (frequency × duration) (ii) Change in cardiorespiratory fitness measured using maximal metabolic equivalent (METmax) on an objective physical fitness test (Chester Step Test) [35] | ✓ | ✓ | ✓ |
Mood | (i) Positive mental health: 4 items from RAND SF-36 questionnaire addressing affective aspects of wellbeing [21] (ii) Nonspecific psychological distress: 5 items from the Mental Health Index-5 (MHI-5) in the RAND SF-36 questionnaire [21] (iii) Depression, anxiety, and stress: 21 items from Depression, Anxiety, and Stress Scale (DASS-21) [22] | ✓ | | ✓ |
Cognition | (i) Perceived social support: Multidimensional Scale of Perceived Social Support from family, friends, and a significant other [25] (ii) Motivation to change: a one item forced choice question with 5 options to assess current stage of change [13] (iii) Diabetes-related self-efficacy: 18-item assessment of confidence to engage in exercise and healthy eating under different “barrier” conditions [13] | ✓ | | ✓ |
Wellbeing | (i) General health: stand-alone measure of self-rated health included in the Irish Survey of Lifestyle, Attitudes, and Nutrition (SLÁN), 2007 [23] (ii) Quality of life: single-item assessment included in SLÁN 2007 [23] | ✓ | | ✓ |
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