Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: Study design and rationale

Background: Obesity and excessive weight gain during pregnancy are associated with adverse pregnancy outcomes. Observational studies suggest that minimal or no gestational weight gain (GWG) may minimize the risk of adverse pregnancy outcomes for obese women. Objective: This report describes the design of Healthy Moms, a randomized trial testing a weekly, group-based, weight management intervention designed to help limit GWG to 3% of weight (measured at the time of randomization) among obese pregnant women (BMI≥30kg/m ²). Participants are randomized at 10-20weeks gestation to either the intervention or a single dietary advice control condition. Primary outcomes: The study is powered for the primary outcome of total GWG, yielding a target sample size of 160 women. Additional secondary outcomes include weight change between randomization and one-year postpartum and proportion of infants with birth weight > 90th percentile for gestational age. Statistical analyses will be based on intention-to-treat. Methods: Following randomization, all participants receive a 45-minute dietary consultation. They are encouraged to follow the Dietary Approaches to Stop Hypertension diet without sodium restriction. Intervention group participants receive an individualized calorie intake goal, a second individual counseling session and attend weekly group meetings until they give birth. Research staff assesses all participants at 34-weeks gestation and at 2-weeks and one-year postpartum with their infants. Summary: The Healthy Moms study is testing weight management techniques that have been used with non-pregnant adults. We aim to help obese women limit GWG to improve their long-term health and the health of their offspring.