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Open Access Highly Accessed Study protocol

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

Annette L Briley1, Suzanne Barr2, Shirlene Badger1, Ruth Bell3, Helen Croker4, Keith M Godfrey56, Bridget Holmes2, Tarja I Kinnunen3, Scott M Nelson7, Eugene Oteng-Ntim1, Nashita Patel1, Stephen C Robson8, Jane Sandall1, Thomas Sanders2, Naveed Sattar7, Paul T Seed1, Jane Wardle4 and Lucilla Poston1*

Author Affiliations

1 Division of Women’s Health, Women’s Health Academic Centre, King’s College London and King’s Health Partners, 10th floor, North Wing, St.Thomas’ Hospital, London SE1 7EH, UK

2 Division of Diabetes and Nutritional Sciences, King’s College London and King’s Health Partners, London, UK

3 Institute of Health & Society, Newcastle University, Newcastle, UK

4 Epidemiology and Public Health, University College London, London, UK

5 MRC LifeCourse Epidemiology Unit, University of Southampton, Southampton, UK

6 NIHR Biomedical Research Unit in Nutrition, Diet and Lifestyle, University of Southampton Hospital NHS Foundation Trust, Southampton, UK

7 Centre for Population and Health Sciences, School of Medicine, University of Glasgow, Glasgow, UK

8 Institute of Cellular Medicine, Newcastle University, Newcastle, UK

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BMC Pregnancy and Childbirth 2014, 14:74  doi:10.1186/1471-2393-14-74

Published: 18 February 2014

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.

Trial registration

Current controlled trials; ISRCTN89971375.

Keywords:
Study protocol; Pregnancy; Obesity; Complex intervention; Randomised controlled trial; Glycemic index; Physical activity; Gestational diabetes; Large for gestational age