A Pilot Randomised Controlled Trial to Evaluate the Impact of Attending The Lifestyle Course (TLC) on the Health of Pregnant Women with a Body Mass Index (BMI) ³30kg/m2 and their Babies

Maternal obesity (Body Mass Index (BMI) ³30kg/m²) is associated with increased risk for adverse maternal and fetal outcomes. Although, pregnancy is a time of increased motivation, currently few public health services are commissioned to offer healthy lifestyle advice to these women. The current programme of work examining an innovative antenatal intervention for women with an antenatal booking BMI ³30kg/m² called The Lifestyle Course (TLC). A pilot two-arm multi-centre randomised controlled trial (RCT) was conducted in two areas of Greater Manchester, UK. This pilot study was informed by a large feasibility study (n=259) and has one main objective to inform a future definitive RCT by providing information on the validity of the study design (including confirmation of the most appropriate primary endpoint). Seventy-two women with an antenatal booking BMI ³30kg/m² were randomised to the control group (standard maternity care) or intervention group (invited to attend TLC). TLC ran for 10-weeks and was underpinned by four cornerstones; collaboration with existing community services (e.g., community teams), multi-disciplinary team (e.g., midwives and health psychologists), multi-component information (e.g., addresses healthy eating and physical activity advice) and application of behaviour change theory (e.g., Social Learning Theory). Mixed method data was collected up to one-year postnatal. The outcomes under investigation are; fetal outcomes (clinical), maternal outcomes (wellbeing/psychological) and neonatal outcomes. The presentation will present data from this pilot study up till the 4-6 week postnatal stage. The implications for the design of the definitive RCT to test the efficacy of the TLC will be outlined. Trial registration: ISRCTN09432573