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Table 1 Secondary outcomes: definitions and measurement techniques

From: An evaluation of Croí MyAction community lifestyle modification programme compared to standard care to reduce progression to diabetes/pre-diabetes in women with prior gestational diabetes mellitus (GDM): study protocol for a randomised controlled trial

  Outcome Definition and measurement Timepoint measured
    Baseline Post-intervention 1-year follow-up
1 Postprandial glucose dysfunction Mean reduction in two-hour postprandial (PP) blood glucose on a 75 gram oral glucose tolerance test (OGTT)  
2 Insulin resistance Decrease in insulin resistance as measured by Homeostasis Model Assessment (HOMA) on insulin and glucose values on a 75 gram OGTT  
3 Diet adherence Two-point improvement in overall MedDietScore - a composite diet index based on the traditional Mediterranean dietary pattern
4 Weight and shape a. Mean weight reduction (kilograms) in individuals with a Body Mass Index (BMI) of >30 kg/m2 at baseline; and
b. Mean reduction in waist circumference in individuals with a measurement of >88 cm at baseline
5 Physical activity and fitness a. Proportions meeting physical activity target of at least 30 minutes of moderate intensity aerobic activity on at least five days of the week; and
b. Change in functional capacity on an objective physical fitness test (Chester Step Test or six-minute walk test), estimated in metabolic equivalents (METs) or time on test
6 Lipid profile a. Proportions achieving a lipid target profile of the following values: total cholesterol <4.5 mmol/l, LDL cholesterol <2.5 mmol/l, triglycerides <1.69 mmol/l, HDL cholesterol >1.29 mmol/l; and
b. Mean reduction in total and LDL cholesterol
7 Psychological evaluation (including: positive mental health; general health; quality of life; perceived social support; motivation to change; diabetes-related self-efficacy; depression, anxiety and stress) a. Positive mental health: four-items from RAND SF-36 questionnaire addressing affective aspects of well-being and five-items from the Mental Health Index-5 (MHI-5) in the RAND SF-36 questionnaire on the occurrence and extent of non-specific psychological distress  
b. General health: Stand-alone measure of self-rated health included in the Irish Survey of Lifestyle, Attitudes and Nutrition (SLÁN), 2007 (originally from The Healthy Days Measures (HRQOL-4))
c. Quality of life: Single-item assessment included in SLÁN 2007 (originally from the World Health Organization’s Quality of Life Survey (WHO-QOL Group, 1998))
d. Perceived social support: Multidimensional Scale of Perceived Social Support from family, friends, and a significant other (Zimet, Dahlem, Zimet and Farley, 1988)
e. Motivation to change: Moore et al.’s (2011) scale developed for Australian randomised controlled trial on a lifestyle intervention programme to prevent type 2 diabetes (based on Prochaska et al.’s (1992) identification of various stages in relation to maintaining a healthier lifestyle)
f. Diabetes-related self-efficacy: 18-item assessment of confidence to engage in exercise and healthy eating under different ‘barrier’ conditions (Moore et al., 2011)
g. Depression, anxiety and stress: 21-item Depression, Anxiety and Stress Scale (DASS-21)