Abstract
BACKGROUND: More than half of pregnant patients with overweight or obesity exceed national gestational weight gain (GWG) guidelines, increasing their risk of adverse outcomes. There is an urgent need to develop effective and scalable interventions to improve GWG. OBJECTIVE: To describe the protocol of Lifestyle, Eating, and Activity in Pregnancy (LEAP), a cluster randomized controlled trial evaluating a mobile health (mHealth) intervention promoting appropriate GWG in an integrated healthcare system. METHODS: LEAP is a cluster randomized trial with randomization at the clinician level. Patient eligibility includes a pre-pregnancy BMI of 25.0-40.0 kg/m(2) and singleton pregnancy. Consented patients receive standard care or standard care plus mHealth intervention per their clinician's randomization. The patient adaptive intervention provides personalized, automated feedback on GWG and physical activity using 1) a smartphone application, 2) a Wi-Fi scale and activity tracker; 3) weekly educational topics; and 4) step-wise support (added when GWG is >75th percentile of the GWG guidelines). Intervention clinicians receive newsletters with motivational interviewing tips to facilitate discussing GWG. Primary outcomes are total GWG (last measured weight - pre-pregnancy weight) and weekly rate of GWG (total GWG/gestational weeks at delivery) as continuous variables and categorized per the IOM GWG guidelines. Secondary outcomes include trimester-specific rate of GWG, GWG trajectory, diet and physical activity, postpartum weight retention, birthweight, infant size for gestational age, and infant growth to 12 months. CONCLUSIONS: LEAP addresses gaps in the implementation of GWG interventions in healthcare settings. The adaptive and mHealth nature of the intervention may enhance scalability. TRIAL REGISTRATION: ClinicalTrials.govNCT03880461.