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 鈮?#xA0;30 kg/m2). Participants are randomized at 10-20 weeks gestation to either the intervention or a single dietary advice control condition.
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.
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.
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.