Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomized controlled trial

BACKGROUND: The global obesity epidemic has led to increased attention on pregnancy, a period when women are at risk of gaining excessive weight. Excessive gestational weight gain is associated with numerous complications, for both mother and child. Though the problem is widespread, few studies have examined the effect of a lifestyle intervention in pregnancy designed to limit maternal weight gain. The Fit for Delivery study will explore the effectiveness of nutritional counseling coupled with exercise classes compared with standard prenatal care. The aims of the study are to examine the effect of the intervention on maternal weight gain, newborn birth weight, glucose regulation, complications of pregnancy and delivery, and maternal weight retention up to 12 months postpartum. METHODS/DESIGN: Fit for Delivery is a randomized controlled trial that will include 600 women expecting their first child. To be eligible, women must be 18 years of age or older, of less than 20 weeks gestational age, with a singleton pregnancy, and have a Body Mass Index (BMI) ≥ 19 kg/m(2). The women will be randomly allocated to either an intervention group or a control group. The control group will receive standard prenatal care. The intervention group will, in addition, receive nutritional counseling by phone, access to twice-weekly exercise sessions, and information on healthy eating and physical activity provided in pamphlets, evening meetings and an interactive website. Both groups will be monitored by weighing (including bioimpedance measurements of percent body fat), blood tests, self-report questionnaires and hospital record review. DISCUSSION: Weight gained in pregnancy affects the health of both the mother and her unborn child, and simple models for efficient intervention are in high demand. The Fit for Delivery intervention provides concrete advice on limiting energy intake and practical training in increasing physical activity. This lifestyle intervention is simple, reproducible, and inexpensive. The design of the study reflects the realities of clinical practice, where patients are free to choose whether or not they respond to health initiatives. If we find measurable health benefits associated with the intervention, it may be an easily adopted supplement to routine prenatal care, in the prevention of obesity. TRIAL REGISTRATION: ClinicalTrial.gov, NCT01001689