Table 3.

Intervention effect (marginal mean difference from randomisation) of the primary outcome (CVD risk score, z-score) at each study time point and for different study group allocations; from mixed effects generalised linear model.

	Time point 6 months (change in CVD risk score from baseline to 6 months post-randomisation)							Time point 12 months (change in CVD risk score from baseline to 12 months post-randomisation)
	Intervention group		Control group		Difference intervention − control			Intervention group		Control group		Difference intervention − control
	Marginal estimate	95% CI	Marginal estimate	95% CI	Marginal estimate	95% CI	P value	Marginal estimate	95% CI	Marginal estimate	95% CI	Marginal estimate	95% CI	P value
ITT model	−0.17	−0.25 to −0.09	−0.04	−0.12 to 0.04	−0.13	−0.24 to −0.01	0.027	−0.22	−0.30 to −0.13	−0.04	−0.12 to 0.04	−0.18	−0.29 to −0.06	0.003
PP1 model	−0.24	−0.35 to −0.12	−0.03	−0.11 to 0.05	−0.20	−0.35 to −0.06	0.004	−0.25	−0.37 to −0.14	−0.03	−0.11 to 0.05	−0.23	−0.37 to −0.09	0.002
PP2 model	−0.22	−0.34 to −0.09	−0.05	−0.16 to 0.06	−0.17	−0.34 to 0.00	0.048	−0.31	−0.44 to −0.18	−0.03	−0.14 to 0.08	−0.28	−0.45 to −0.11	0.001
PP3 model	−0.22	−0.34 to −0.10	−0.05	−0.15 to 0.06	−0.17	−0.33 to −0.01	0.033	−0.30	−0.41 to −0.18	−0.03	−0.14 to 0.08	−0.27	−0.43 to −0.11	0.001

CI confidence interval, CVD cardiovascular disease, ITT intention-to-treat, PP1 per protocol analysis 1, PP2 per protocol analysis 2, PP3 per protocol analysis 3.

The estimates represent the change in the CVD risk score [z-score] from baseline to 6 and 12 months post-randomisation for the intervention and control group. A negative score represents a reduction in the CVD risk and therefore a favourable outcome. The group allocation differed for each of the models. ITT (intention-to-treat): allocation as randomised (N = 151); PP1 (per protocol analyses 1): control group included participants with <5% increase in maximal power, intervention group included participants with ≥5% increase in maximal power (N = 112); PP2 (per protocol analysis 2): included compliant intervention and control participants only, based on daily self-reported physical activity data with missing days set to 0 activities (N = 82); PP3 (per protocol analysis 3): included compliant intervention and control participants only, based on daily self-reported physical activity data with missing days set to the annual average of activities (N = 87). The models were adjusted for sex, main diagnostic group and baseline CVD risk score. See Fig. 2 for a graphical display of the same results reported in Table 3.

Bold value means a significant p-value based on the significance level of α < 0.05.