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Table 3 Power for the three main outcomes for different combinations of effect sizes and assuming an ICC of 0.02, a CAC of 0.8, and a type I error rate of 0.05. Power for non-linear models calculated using a normal approximation. pp percentage point

From: Protocol for a parallel group, two-arm, superiority cluster randomised trial to evaluate a community-level complementary-food safety and hygiene and nutrition intervention in Mali: the MaaCiwara study (version 1.3; 10 November 2022)

Outcome

Assumed model

Assumed baseline

Effect size

Obs. per cluster period

Power

Primary outcomes

 Water and food safety and hygiene behaviour

Binomial-logistic

50%

 + 5 pp

27 mother–child pairs

4 opportunities per pair

69%

 + 10 pp

 > 99%

 + 20 pp

 > 99%

 Food and water contamination

Poisson

10 cfu/g

 − 1

10 samples per cluster

 > 99%

 − 2

 > 99%

 Diarrhoea

Binomial-logistic

13%

 − 2 pp

27 mother–child pairs

33%

 − 3 pp

64%

 − 5 pp

97%

 − 7 pp

 > 99%

Outcome

Assumed model

Assumed baseline

Main effect

Interaction effect

Obs. per cluster period

Power

Subgroup analyses

 Water and food safety and hygiene behaviour

Binomial-logistic

50%

0 pp

 + 5 pp

27 mother–child pairs

4 opportunities per pair

67%

0 pp

 + 10 pp

 > 99%

 + 5 pp

 + 5 pp

69%

 + 5 pp

 + 10 pp

 > 99%

 Food and water contamination

Poisson

10 cfu/g

0

 − 1

10 samples per cluster

29%

0

 − 2

84%

 − 2

 − 1

34%

 − 2

 − 2

91%

 Diarrhoea

Binomial-logistic

13%

0 pp

 − 2 pp

27 mother–child pairs

11%

0 pp

 − 5 pp

54%

 − 2 pp

 − 2 pp

13%

 − 2 pp

 − 5 pp

65%

 − 5 pp

 − 2 pp

18%