A complex intervention to improve pregnancy outcome in obese women; the UPBEAT randomised controlled trial

Briley, A. L. et al. (2014) A complex intervention to improve pregnancy outcome in obese women; the UPBEAT randomised controlled trial. BMC Pregnancy and Childbirth, 14, 74. (doi:10.1186/1471-2393-14-74) (PMID:24533897) (PMCID:PMC3938821)

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Abstract

Background: Despite the widespread recognition that obesity in pregnant women is associated with adverse outcomes for mother and child, there is no intervention proven to reduce the risk of these complications. The primary aim of this randomised controlled trial is to assess in obese pregnant women, whether a complex behavioural intervention, based on changing diet (to foods with a lower glycemic index) and physical activity, will reduce the risk of gestational diabetes (GDM) and delivery of a large for gestational age (LGA) infant. A secondary aim is to determine whether the intervention lowers the long term risk of obesity in the offspring.

Methods/Design: Multicentre randomised controlled trial comparing a behavioural intervention designed to improve glycemic control with standard antenatal care in obese pregnant women.

Inclusion criteria; women with a BMI ≥30 kg/m2 and a singleton pregnancy between 15+0 weeks and 18+6 weeks’ gestation. Exclusion criteria; pre-defined, pre-existing diseases and multiple pregnancy. Randomisation is on-line by a computer generated programme and is minimised by BMI category, maternal age, ethnicity, parity and centre. Intervention; this is delivered by a health trainer over 8 sessions. Based on control theory, with elements of social cognitive theory, the intervention is designed to improve maternal glycemic control. Women randomised to the control arm receive standard antenatal care until delivery according to local guidelines. All women have a 75 g oral glucose tolerance test at 27+0- 28+6 weeks’ gestation.

Primary outcome; Maternal: diagnosis of GDM, according to the International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria. Neonatal; infant LGA defined as >90th customised birth weight centile.

Sample size; 1546 women to provide 80% power to detect a 25% reduction in the incidence of GDM and a 30% reduction in infants large for gestational age.

Discussion: All aspects of this protocol have been evaluated in a pilot randomised controlled trial, with subsequent optimisation of the intervention. The findings of this trial will inform whether lifestyle mediated improvement of glycemic control in obese pregnant women can minimise the risk of pregnancy complications.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Sanders, Prof Thomas and Nelson, Professor Scott and Poston, Prof Lucilla and Sattar, Professor Naveed
Authors: Briley, A. L., Barr, S., Badger, S., Bell, R., Croker, H., Godfrey, K. M., Holmes, B., Kinnunen, T. I., Nelson, S. N., Oteng-Ntim, E., Patel, N., Robson, S. C., Sandall, J., Sanders, T., Sattar, N., Seed, P. T., Wardle, J., and Poston, L.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:BMC Pregnancy and Childbirth
Publisher:BioMed Central
ISSN:1471-2393
ISSN (Online):1471-2393
Copyright Holders:Copyright © 2014 The Authors
First Published:First published in BMC Pregnancy and Childbirth 14(74)
Publisher Policy:Reproduced under a Creative Commons License
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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
509251Improving pregnancy outcome in obese women (UK Better Eating and Activity Trial - UPBEAT)Naveed SattarNational Institute for Health Research (NIHR)RP-PG-0407-1045RI CARDIOVASCULAR & MEDICAL SCIENCES