The effect of youths as change agents on cardiovascular disease risk factors among adult neighbours: a cluster randomised controlled trial in Sri Lanka

Table 2 Effect of intervention on primary and secondary outcomes at 12th-month follow-up

	Intervention group (n = 245)		Control group (n = 238)		Between-group difference at follow-up^c
	Mean ± SD, median (IQR)⁺, or number (%) at the end of the follow-up	Mean ± SD of change from baseline^a	Mean ± SD, median (IQR)⁺, or number (%) at the end of the follow-up	Mean ± SD of change from baseline^a	Difference in means^b or OR (95% CI)	p-value
Primary outcomes
Body weight (kg)	61.8 ± 12.7	−1.51 ± 3.18	64.0 ± 12.8	1.36 ± 2.30	− 2.83 (− 3.31, − 2.35)^b	< 0.001
BMI (kg/m²)	24.4 ± 4.4	− 0.59 ± 1.27	25.5 ± 4.7	0.54 ± 0.95	− 1.12 (− 1.32, − 0.94)^b	< 0.001
Systolic blood pressure (mmHg)	127.1 ± 18.9	0.44 ± 15.4	128.4 ± 18.1	1.11 ± 13.4	−0.88 (− 3.18, 1.42)^b	0.45
Diastolic blood pressure (mmHg)	84.0 ± 10.7	0.44 ± 10.6	85.4 ± 10.1	1.01 ± 9.20	−0.94 (− 2.64, 0.77)^b	0.28
Secondary outcomes
Physical activity
Leisure-time physical activities, recommended level^d	31 (12.7)		20 (8.4)		1.58 (0.84, 2.96)	0.15
Sedentary times (minutes/day)	180 (120, 300)⁺	3.33 ± 180	180 (120, 300)⁺	5.27 ± 140	1.16 (− 28.0, 30.3)^b	0.94
Dietary intake
Vegetables, ≥ two servings/day	106 (43.3)		92 (38.7)		1.24 (0.79, 1.94)	0.35
Fruits, ≥ one serving/day	112 (45.7)		82 (34.5)		1.71 (1.10, 2.65)	0.02
Snacks, ≥ twice/day	52 (21.2)		107 (45.0)		0.32 (0.21, 0.48)	< 0.001
Sugar-sweetened beverages, ≥ once/day	14 (5.7)		15 (6.3)		0.86 (0.35, 2.09)	0.74
Current smoking	29 (11.8)		29 (12.2)		0.86 (0.32, 2.31)	0.77
Alcohol intake, > low risk of drinking level^e	9 (11.8)		17 (22.1)		0.50 (0.15, 1.71)	0.27

BMI body mass index, SD standard deviation, IQR inter-quartile range, CI confidence interval
^aChange from baseline = outcome values at the end of the follow-up – outcome values at baseline
^bThe analysis of ‘difference in means’ was used the calculated outcome of ‘change from baseline’
^cMultilevel linear regression for continuous outcomes and multilevel logistic regression for binary outcomes, with Grama Niladari divisions as the cluster variable and adjustment for each outcome variable at baseline
^dRecommended leisure-time physical activity was defined over 3 hours/week of 4.5 metabolic-equivalents (METs) of moderate-intense physical activity or over 1 hour/week of 7.5 METs of vigorous-intense physical activity
^elow risk of drinking level was two drinks/day for men and one drink/day for women

ISSN: 1471-2458