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Table 1 The detectable risk reduction for T2D in the intervention compared to the control group. Power was set to 80% and p < 0.05. There were a total of 60 clusters with 30 participants in each cluster. Alternate assumptions were compared, e.g. 10% drop-out in clusters and 10 and 20% drop-outs rates in participants and with 20% and 40% lower T2D event rates than estimated. The baseline predicted event rate for the control group was 6.8% per year or 19.0% in 3 years

From: The iHealth-T2D study: a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes—a statistical analysis plan

Assumptions

Detectable risk reduction

Drop-out rate clusters

Event rate

Drop-out rate participants

ICC

0% (n = 60)

Baseline (19.0% in 3 years)

0% (n = 30/cluster)

0.01

21%

0% (n = 60)

Baseline (19.0% in 3 years)

0% (n = 30/cluster)

0.05

28%

0% (n = 60)

Baseline (19.0% in 3 years)

0% (n = 30/cluster)

0.1

35%

0% (n = 60)

Baseline (19.0% in 3 years)

10% (n = 27/cluster)

0.01

22%

0% (n = 60)

Baseline (19.0% in 3 years)

10% (n = 27/cluster)

0.05

29%

0% (n = 60)

Baseline (19.0% in 3 years)

10% (n = 27/cluster)

0.1

36%

0% (n = 60)

Baseline (19.0% in 3 years)

20% (n = 24/cluster)

0.01

23%

0% (n = 60)

Baseline (19.0% in 3 years)

20% (n = 24/cluster)

0.05

30%

0% (n = 60)

Baseline (19.0% in 3 years)

20% (n = 24/cluster)

0.1

36%

10% (n = 54)

Baseline (19.0% in 3 years)

10% (n = 27/cluster)

0.01

22%

10% (n = 54)

Baseline (19.0% in 3 years)

10% (n = 27/cluster)

0.05

30%

10% (n = 54)

Baseline (19.0% in 3 years)

10% (n = 27/cluster)

0.1

37%

0% (n = 60)

20% lower (15.2% in 3 years)

10% (n = 27/cluster)

0.01

24%

0% (n = 60)

20% lower (15.2% in 3 years)

10% (n = 27/cluster)

0.05

32%

0% (n = 60)

20% lower (15.2% in 3 years)

10% (n = 27/cluster)

0.1

40%

0% (n = 60)

40% lower (11.4% in 3 years)

10% (n = 27/cluster)

0.01

28%

0% (n = 60)

40% lower (11.4% in 3 years)

10% (n = 27/cluster)

0.05

37%

0% (n = 60)

40% lower (11.4% in 3 years)

10% (n = 27/cluster)

0.1

46%