Living Well during Pregnancy: Protocol for the implementation of a tele-coaching healthy lifestyle program for women at high risk of excess gestational weight gain (Preprint)
BACKGROUND Despite comprehensive guidelines for healthy gestational weight gain (GWG) and evidence for the efficacy of dietary counselling coupled with weight monitoring, reporting on the effectiveness of interventions into routine antenatal care is limited. OBJECTIVE This study aims to implement and evaluate the Living Well during Pregnancy (LWdP) program in a large, Australian antenatal care setting. Specifically, LWdP will be incorporated into usual care and will be delivered to a population of pregnant women at risk of excessive GWG through a dietitian-delivered telephone coaching service. METHODS Metrics from the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework will guide the evaluation in this hybrid effectiveness-implementation study. All women aged ≥16 years, without pre-exiting diabetes with a pre-pregnancy BMI > 25kg/m2 or a pre-pregnancy BMI<25kgm2 and gaining weight above recommendations at <20 weeks gestation referred for dietetic care during the 12 month study period will be eligible for participation. The setting is a metropolitan hospital that has approximately 6% of the national births per year. Eligible participants will receive up to 10 tele-coaching calls during their pregnancy. Primary outcomes are service level indicators of reach, adoption, and implementation which will be compared to a retrospective control group, with secondary effectiveness outcomes of participant reported anthropometric and behavioural outcomes assessed at pre and post program completion. Additional secondary outcomes relate to the costs associated with program implementation and pregnancy outcomes gathered through routine clinical service data. RESULTS Data collection will be completed at the end of 2020, with results expected to be published by the end of 2021. CONCLUSIONS This study evaluating the implementation of an evidence-based intervention into routine health service delivery will provide the practice-based evidence needed to inform decisions about its incorporation into routine antenatal care.