Implementation of the Living Well During Pregnancy Telecoaching Program for Women at High Risk of Excessive Gestational Weight Gain: Protocol for an Effectiveness-Implementation Hybrid Study

BACKGROUND: Despite comprehensive guidelines for healthy gestational weight gain (GWG) and evidence for the efficacy of dietary counseling coupled with weight monitoring on reducing excessive GWG, reporting on the effectiveness of interventions translated 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, the LWdP program will be incorporated into usual care and 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, and Maintenance) framework will guide the evaluation in this hybrid effectiveness-implementation study. All women aged ≥16 years without pre-exiting diabetes with a prepregnancy BMI >25 kg/m(2) and gaining weight above recommendations at <20 weeks’ gestation who are referred for dietetic care during the 12-month study period will be eligible for participation. The setting is a metropolitan hospital at which approximately 6% of the national births in Australia take place each year. Eligible participants will receive up to 10 telecoaching calls during their pregnancy. Primary outcomes will be service level indicators of reach, adoption, and implementation that will be compared with a retrospective control group, and secondary effectiveness outcomes will be participant-reported anthropometric and behavioral outcomes; all outcomes will be assessed pre- and postprogram completion. Additional secondary outcomes relate to the costs associated with program implementation and pregnancy outcomes gathered through routine clinical service data. RESULTS: Data collection of all variables was completed in December 2020, with results expected to be published by the end of 2021. CONCLUSIONS: This study will evaluate the implementation of an evidence-based intervention into routine health service delivery and will provide the practice-based evidence needed to inform decisions about its incorporation into routine antenatal care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27196