Healthy eating and lifestyle in pregnancy (HELP): a protocol for a cluster randomised trial to evaluate the effectiveness of a weight management intervention in pregnancy

Table 1 Measurement of Outcomes

Outcomes	Measure	When*
Primary outcome
Maternal weight expressed as BMI relative to height measured at baseline	Calibrated adult scales & stadiometer	B, 36w, 6p, 6 m, 12 m
Secondary outcomes
Antenatal and birth complications**	Routinely collected data held in patient records	Birth
Pregnancy weight gain	Calibrated adult scales	B, 36w
Waist circumference and waist-hip ratio	Measuring tape	12 m
Child weight centile (adjusted for birth weight and age)	Calibrated baby scales and measuring tape	Birth, 6p, 6 m, 12 m
Admission to neonatal unit	Patient records	Birth
General mental health	General Health Questionnaire (GHQ) 12 [82]	B, 36w, 6p, 6 m, 12 m
Breast feeding intentions	Study-developed questions	36w
Breast feeding behaviour and weaning	Study-developed questions	6p, 6 m, 12 m
Self-reported physical activity	7 Day Physical Activity Recall (7 Day PAR) [83–85]	B, 36w, 6p, 6 m, 12 m
Diet	Dietary Instrument for Nutrition Education (DINE) [86] (plus additional questions on fruit and vegetables, sugar, sweets)	B, 36w, 6p, 6 m, 12 m
Alcohol	Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) [87]	B, 36w, 6p, 6 m, 12 m
Smoking	Study-developed questions	B, 36w, 6p, 6 m, 12 m
Costs	Participant resource use	B, 36w, 6p, 6 m, 12 m
Health related quality of life	EQ-5D (including visual analogue scale) [88]	B, 36w, 6p, 6 m, 12 m

*B = baseline; 36w = 36 weeks gestation; 6p = 6 weeks postpartum; 6 m = 6 months postpartum; 12 m =12 months postpartum.
**gestational diabetes; pre-eclampsia; thrombosis; proportion staying within IOM guidance on weight gain in pregnancy [20]; form of pain relief; birth delivery mode; gestation at delivery; induction of labour; shoulder dystocia, 3^rd/4^th degree perineal tear; postpartum bleeding or thrombosis; Apgar scores.

ISSN: 1471-2458