Table 1.
Primary outcomes and effect sizes
Primary outcome | Experimental mean change | Sham control Mean change | Pooled standard deviation | Effect size (d) | Sample required (total cohort) |
---|---|---|---|---|---|
HOMA2-IR | −0.6 | 0 | 0.8 | 0.75 | 52 |
HbA1c (mmol/mol) | −13.1 | 0 | 18.6 | 0.70 | 78 |
Sample size estimates were driven by hypothesized differences between the experimental and control participants in the primary outcomes of the trial: insulin resistance and glucose homeostasis, as measured using HOMA2-IR and HbA1c respectively. Effect sizes were calculated based on an average of published studies of PRT in diabetes/obesity [6, 26].
HbA1c glycosylated hemoglobin, HOMA2-IR homeostatic model of assessment of insulin resistance 2