Table 3.

Infant sleep diary and actigraphy data at 6 months of age

					p Value for intervention
	Control	FAB	Sleep	Combination	∆ Four groups	∆ Two groups*
Diary†
24-Hour sleep duration (min)‡	840 (96)	828 (96)	828 (90)	822 (96)	0.631	0.383
Overnight sleep duration (min)‡	654 (84)	648 (78)	642 (78)	636 (78)	0.248	0.086
No night wakings‡	1.5 (1.5)	2.0 (1.5)	1.5 (1.5)	2.0 (2.0)	0.397	0.729
Overnight sleep efficiency (%)	92.1 (13.6)	91.1 (12.0)	90.0 (14.3)	90.4 (12.2)	0.514	0.317
No daytime naps	2.6 (1.3)	2.6 (1.4)	2.7 (1.4)	2.8 (1.3)	0.379	0.096
Longest sleep period overnight (min)	444 (168)	426 (186)	426 (174)	414 (168)	0.536	0.457
Actigraphy§
Sleep onset (hour:min)	20:12 (78)	20:12 (72)	20:24 (78)	20.24 (78)	0.415	0.102
Sleep offset (hour:min)	6:54 (60)	6:54 (60)	6:54 (60)	7:00 (60)	0.293	0.319
24-Hour sleep duration (min)‡	616.4 (94.6)	618.5 (90.7)	615.1 (94.4)	621.7 (93.0)	0.554	0.635
Overnight sleep duration (min)‡	538.9 (105.5)	532.3 (88.2)	528.6 (99.7)	544.1 (95.1)	0.157	–
No night wakings‡	2.6 (1.6)	2.6 (1.5)	2.4 (1.4)	2.4 (1.5)	0.100	0.018
Total night wake (min)	107.7 (87.4)	106.2 (68.6)	104.7 (88.2)	91.4 (68.3)	0.051	0.092
Overnight sleep efficiency (%)	83.5 (12.3)	83.5 (10.4)	83.8 (12.3)	85.7 (10.6)	0.063	0.120
No daytime naps	1.7 (0.9)	1.7 (0.8)	1.7 (0.9)	1.8 (0.8)	0.871	0.544
Nap duration (min)	91.5 (55.4)	92.3 (53.8)	98.9 (57.4)	97.0 (55.5)	0.147	0.025

Data are presented as mean (SD) unless stated otherwise.

*‘Sleep’ (control and FAB combined) versus ‘No Sleep’ (sleep and combination combined).

†Analyses use mean of 2 days from 507 participants with available data.

‡Secondary outcome to the main RCT.³⁰ All others variables are additional outcomes.

§Analyses use mean of 3–7 days (median 4 days) from 498 participants with available data.

–, No analyses due to interaction between sleep and FAB groups.

FAB, food, activity and breastfeeding intervention; RCT, randomised controlled trial.