LIFE-Moms (Phoenix center) is a randomized clinical trial in overweight and obese pregnant women that will test the effects of an intensive lifestyle intervention on gestational weight gain, control of maternal hyperglycemia, and post-partum return to pre-pregnancy weight. The Phoenix center will be conducted in collaboration between the Phoenix Indian Medical Center (PIMC) nurse midwifery and obstetrics services and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It is part of the LIFE-Moms Consortium consisting of six other clinical centers that will follow similar protocols and a research coordination unit.
American Indians are at high risk for developing obesity and type 2 diabetes mellitus (T2DM) and its complications. A major factor responsible for this finding is exposure of the fetus in the womb to its mother s diabetes, which increases the risk of diabetes in the offspring particularly during childhood and adolescence. This study is designed to evaluate the effects of an intensive lifestyle intervention (ILI) in at least 200 adult (age greater than or equal to 18 years) pregnant women who are eligible for prenatal care at PIMC. Interventions will be provided to overweight and obese pregnant women who do not have pregestational diabetes but may have (GDM), i.e., diabetes that first develops or is first recognized in pregnancy, or are at high risk of developing GDM. The lifestyle intervention will be patterned after the Diabetes Prevention Program (DPP) that prevented or delayed the onset of diabetes in non pregnant adults; the interventions will be modified to be appropriate in pregnancy. For women who develop diabetes, interventions will include coaching to optimize glycemic control.
Women will be randomly assigned to one of two intervention groups, assigned with equal probability: an enhanced standard of care group or an intensive lifestyle intervention group (ILI). Following delivery, all the mothers and infants will be treated in the same way regardless of their initial treatment group. For example, all mothers will be encouraged to breast feed and follow other recommended practices for the health of themselves and their babies. After delivery the mother will be invited to bring the infant to the research clinic five times during the first 6 months and again at 1 year of age. These follow up visits for the infant are timed 1) to understand the patterns of change in neonatal body composition and 2) to coincide, when possible, with well-child pediatric visits. We will also question the mothers and abstract data from the medical record regarding the child s feeding practice, overall health, hospitalizations, immunizations, and medicine use.
Outcomes will be assessed on the same schedule for both intervention groups. Prenatal measurements include demographic, anthropometric, and biochemical data. The latter will focus on periodic measures related to blood glucose (sugar), including glucose tolerance tests. Diet and physical activity will be assessed by questionnaires and objective activity monitors. Many of these tests will be repeated in the mother at 6-12 weeks and 12 months post-partum. Infant data at or shortly after birth and at months 1 through 6 and 12 will include weight, length, head size, estimated body fat, feeding practices, and medical record abstraction.
