Background:

Obesity in pregnancy is associated with insulin resistance, which underpins many common complications including gestational diabetes mellitus (GDM) and fetal macrosomia.

Objectives:

To assess the effect of a complex behavioural intervention based on diet and physical activity (PA) on the risk of GDM and delivery of a large-for-gestational age (LGA) infant.

Design:

Three phases: (1) the development phase, (2) the pilot study and (3) a multicentre randomised controlled trial (RCT) comparing a behavioural intervention to improve glycaemic control with standard antenatal care in obese pregnant women. A cost–utility analysis was undertaken to estimate the cost-effectiveness of the health training (intervention) over and above standard care (control).

Setting:

Pilot study: antenatal clinics in four inner-city UK hospitals. RCT: eight antenatal clinics in eight UK inner-city hospitals.

Participants:

Women were eligible for inclusion if they had a body mass index of ≥ 30 kg/m², were pregnant with a single fetus and at 15⁺⁰ to 18⁺⁶ weeks’ gestation, were able to give written informed consent and were without predefined disorders.

Intervention:

The intervention comprised an initial session with a health trainer, followed by eight weekly sessions. Dietary advice recommended foods with a low dietary glycaemic index, avoidance of sugar-sweetened beverages and reduced saturated fats. Women were encouraged to increase daily PA.

Main outcome measures:

Development phase: intervention development, acceptability and optimal approach for delivery. Pilot study: change in dietary and PA behaviours at 28 weeks’ gestation. RCT: the primary outcome of the RCT was, for the mother, GDM [as measured by the International Association of the Diabetes and Pregnancy Study Groups (IADPSG)’s diagnostic criteria] and, for the infant, LGA delivery (i.e. customised birthweight ≥ 90th centile for gestational age).

Results:

Development phase: following a literature meta-analysis, a study of dietary intention questionnaires and semistructured interviews, an intervention based on behavioural science was developed that incorporated optimal and acceptable methods for delivery. Pilot study: the pilot study demonstrated improvement in dietary behaviours in the intervention compared with the standard care arm but no increase in objectively measured PA. Process evaluation demonstrated feasibility and general acceptability. RCT: the RCT showed no effect of the intervention on GDM in obese pregnant women or the number of deliveries of LGA infants. There was a reduction in dietary glycaemic load (GL) and reduced saturated fat intake, an increase in PA and a modest reduction in gestational weight gain, all secondary outcomes. Lower than expected was the number of LGA infant deliveries in all women, which suggested that universal screening for GDM with IADPSG’s diagnostic criteria, and subsequent treatment, may reduce the number of deliveries of LGA infants. According to the cost–utility analysis, the estimated probability that the UK Pregnancies Better Eating and Activity Trial (UPBEAT) behavioural intervention is cost-effective at the £30,000/quality-adjusted life-year willingness-to-pay threshold was 1%.

Limitations:

Included the high refusal rate for participation and self-reported assessment of diet and PA.

Conclusions:

The UPBEAT intervention, an intense theoretically based intervention in obese pregnant women, did not reduce the risk of GDM in women or the number of LGA infant deliveries, despite successfully reducing the dietary GL. Based on total cost to the NHS provider and health gains, the UPBEAT intervention provided no supporting evidence to suggest that the intervention represents value for money based on the National Institute for Health and Care Excellence benchmarks for cost-effectiveness.

Future work:

Alternative strategies for reducing the risk of GDM in obese pregnant women and the number of LGA infant deliveries should be considered, including development of clinically effective interventions to prevent obesity in women of reproductive age, of clinically effective interventions to reduce weight retention following pregnancy and of risk stratification tools in early pregnancy.

Trial registration:

Current Controlled Trials ISRCTN89971375 and UK Clinical Research Network Portfolio 5035.

Funding:

This project was funded by the NIHR Programme Grant for Applied Research programme and will be published in full in Programme Grants for Applied Research, Vol. 5, No. 10. See the NIHR journals library website for further project information. Contributions to funding were also provided by the Chief Scientist Office CZB/4/680, Scottish Government Health Directorates, Edinburgh; Guys and St Thomas’ Charity, Tommy’s Charity (Lucilla Poston, Annette L Briley, Paul T Seed) and the NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, UK and the Academy of Finland, Finland. Keith M Godfrey was supported by the National Institute for Health Research through the NIHR Southampton Biomedical Research Centre. Lucilla Poston and Keith M Godfrey were supported by the European Union’s Seventh Framework Programme (FP7/2007-2013), project EarlyNutrition under grant agreement number 289346.

Article history

The research reported in this issue of the journal was funded by PGfAR as project number RP-PG-0407-10452. The contractual start date was in August 2008. The final report began editorial review in December 2015 and was accepted for publication in September 2016. As the funder, the PGfAR programme agreed the research questions and study designs in advance with the investigators. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PGfAR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Lucilla Poston has received payment from International Life Sciences Institute Europe as reimbursement of expenses incurred in attending a workshop on obese pregnancy and long-term outcomes and was paid as a member of the Tate and Lyle Research Advisory Group 2007–10, before submission of this work. Lucilla Poston also reports a research grant from Abbott Nutrition, outside the submitted work. Thomas AB Sanders reports personal consultancy fees from the Natural Hydration Council, Heinz Foods, Archer Daniels Midland, the Global Dairy Platform and GlaxoSmithKline, outside the submitted work, and is a trustee and scientific governor for the British Nutrition Foundation, outside the submitted work. Keith M Godfrey reports reimbursement of travel and accommodation expenses from the Nestlé Nutrition Institute, outside the submitted work; research grants from Abbott Nutrition and Nestec, outside the submitted work; and patents pending for phenotype prediction, predictive use of 5‘-C-phosphate-G-3’ (CPG) methylation and maternal nutrition composition, outside the submitted work. During the period of research reported here, Jane Sandall was a member of the National Institute for Health Research (NIHR) Programme Grants for Applied Research core group of methodological experts (2011–15), and of the NIHR Health Services and Delivery Research Programme Commissioning Board (2012–15) and Stephen C Robson was a Medical Research Council/NIHR Efficacy and Mechanism Evaluation board member (2012–15).