Objectives To develop a lifestyle intervention to improve pregnancy outcome in obese pregnancies.
Methods In accord with UK MRC guidelines a phased approach towards development of an randomised controlled trials (RCT) was adopted by a multidisciplinary team. This included Phase I literature review and protocol development; Phase II pilot RCT to assess behavioural change and practicality; Phase III (multicentre RCT; primary outcomes; maternal oral glucose tolerance test; neonatal, macrosomia, n=2700) will follow demonstration of behavioural change in the pilot.
Results An intervention based on dietary advice (low glycaemic index, low saturated fat and reduced free sugars) and increased physical activity was developed. Advice is delivered by a health trainer in eight structured sessions between 19 and 28 week's gestation and reinforced by a participant handbook, log book and physical activity DVD. Data are entered on an internet database. Recruitment to the pilot phase is complete. 136 obese pregnant women (body mass index; 36.7±6 kg/m2; 47 nullips,71 multips; age 30±5 years; 69 white; 42 black, 7 other) have been randomised to the intervention or standard antenatal care. Physical activity is monitored by accelerometry (1 week×3) and validated questionnaire, and diet by 24 h food recall (double- pass ×3). A lifestyle questionnaire in used to assess knowledge and attitudes. Behavioural changes will be analysed in Feb 2011 and presented at the meeting.
Conclusion A pilot study of a complex intervention has been successfully implemented. This step wise approach has enabled detailed development, refinement and evaluation of each component, leading to an intervention acceptable to obese pregnant women.
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Funding Supported by NIHR, CSO.