Lifestyle Interventions for Expectant Moms (LIFE-Moms)
Study Design: Clinical Trial
Duration: 2012 – Present
# Recruitment Centers: 1
Treatment: Behavioral Training
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Access to samples for Lifestyle Interventions for Expectant Moms (LIFE-Moms) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT01812694
Studies have shown that overweight and obese women are at increased risk for several complications of pregnancy, including gestational diabetes mellitus, hypertension, preeclampsia, and cesarean delivery. Additionally, the children of overweight or obese pregnant women show an increased risk of prematurity, congenital anomalies, and childhood obesity. The Lifestyle Interventions for Expectant Mothers (LIFE-Moms) Consortium is a network of seven clinical centers and a data coordinating center that was established by the NIDDK to identify effective behavioral and lifestyle interventions that improve weight, glycemic control, and outcomes in obese and overweight pregnant women and their children. The Lifestyle Interventions for Expectant Moms- Phoenix study, one of the trials conducted by the LIFE-Moms Consortium, is a randomized clinical trial to test the efficacy of an intensive lifestyle intervention on gestational weight gain, control of maternal hyperglycemia, return to post-partum weight, and achieving appropriate infant growth in overweight and obese pregnant women and their offspring.
Pregnant women with a body mass index (BMI) ≥ 25 kg/m2 and without pre-gestational diabetes mellitus who receive prenatal care at the Phoenix Indian Medical Center are enrolled. The study consists of two phases. In the first phase, the woman completes three study visits to obtain data about health early in pregnancy. Participants undergo a physical exam, supply medical history, and provide specimens for examination of possible genetic conditions. Oral glucose tolerance tests are done to determine if a woman has developed gestational diabetes. In the second phase of the study, women are monitored through their pregnancy and the first year after their child’s birth. Participants are randomly assigned to either an enhanced standard of care group or an intensive lifestyle intervention group. In the enhanced standard of care group, participants are given additional information about pregnancy and encouraged to attend three classes to learn about maintaining health during pregnancy. The intensive lifestyle intervention, adapted from the Diabetes Prevention Program, aims at controlling excessive gestational weight gain through diet and physical activity counseling and is delivered through structured group and individual sessions. The intervention continues until delivery. Following delivery, both mother and child participate in study visits to collect information regarding the child’s weight, body size, body composition, feeding practice, overall health, hospitalizations, and immunizations. The primary outcome measure is gestational weight gain, assessed by serial weight measurements up to 36 weeks gestation. Secondary outcome measures include development of gestational diabetes (assessed at 24-28 weeks gestation, 6 weeks post-partum, and 1 year post-partum) and neonatal body weight for length, evaluated from birth and at study visits up to 12 months of age.
This study is ongoing.
The study investigates the efficacy of an intensive lifestyle intervention on gestational weight gain, control of maternal hyperglycemia, return to post-partum weight, and achieving appropriate infant growth in overweight and obese pregnant women and their offspring.
The primary outcome measure is gestational weight gain, assessed by serial weight measurements up to 36 weeks gestation. Secondary outcome measures include development of gestational diabetes (assessed at 24-28 weeks gestation, 6 weeks post-partum, and 1 year post-partum) and neonatal body weight for length, evaluated from birth and at study visits up to 12 months of age.
Pregnant women at least 18 years of age who meet the following criteria are eligible for the study:
- Receive prenatal care at the Phoenix Indian Medical Center and plan to continue receiving such care throughout the pregnancy.
- Able to have an oral glucose tolerance test prior to 16 weeks gestation.
- No diagnosis of diabetes prior to pregnancy.
- Able to commit the time required for the interventions and follow-up
- Singleton viable pregnancy. A twin pregnancy reduced to singleton before 14(0) weeks by project gestational age is acceptable.
- Body mass index ≥ 25 kg/m2 based on first trimester measured weight and on measured height.
Exclusion criteria are documented in the study protocol.
This study is ongoing.