Lifestyle Interventions for Expectant Mothers (LIFE-Moms Phoenix) - Phoenix

Obesity Clinical Trial

Official title: Lifestyle Interventions for Expectant Moms (LIFE-Moms) Phoenix

Status Completed

Clinical Trial Summary

Background:

• LIFE-Moms (Lifestyle Interventions for Expectant Moms) is a national project that is studying pregnant women who are overweight or obese. It is looking at ways they can manage their weight gain in pregnancy and how this may affect them and their babies health at birth and through the first year. Researchers want to recruit pregnant women who are being treated at the Phoenix Indian Medical Center. They will participate in a two-part study.

Objectives:

• To study pregnant women who are in the LIFE-Moms project at the Phoenix Indian Medical Center.

Eligibility:

• Pregnant women at least 18 years of age who are overweight or obese.

• Participants must be receiving care at the Phoenix Indian Medical Center.

• Participants must be having only one child in their pregnancy (no twins or other multiple births).

Design:

• This study will have two parts. The first part will have three visits to obtain data about health early in pregnancy. It will also let participants and researchers find out if the participants are eligible and should continue in the second part of the study. In the second part, participants will be monitored throughout their pregnancy and during the first year after the baby s birth to test the effects of a lifestyle intervention to control weight gain during pregnancy.

• On the Part 1 study visits, participants will have a physical exam and medical history. They will provide blood, urine, hair, and other samples to be examined for possible genetic conditions.

• For the Part 2 study visits, participants will be placed in one of two treatment groups. Each group will receive the same prenatal and postnatal care that they would get if they did not join the study.

• The first group will have a lifestyle intervention program. They will spend about 2 hours every week with other members of their group to learn diet and activity behaviors that may help with their health.

• The second group will have an enhanced care program. They will be given additional information about health and pregnancy and be invited to attend three classes to learn about staying healthy during pregnancy.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Diet Therapy
• Obesity

• NCT number: NCT01812694
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2013
• Completion date: March 27, 2017