Number of Subjects in Study Archive: 924
Study Design: Interventional
Conditions: Diabetes Mellitus, Type 2, Obesity
Division: DDN
Duration: October 2012 - June 2020
# Recruitment Centers: 7
Treatment: Behavioral Training
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URLs:
http://www.clinicaltrials.gov/show/NCT01812694, https://clinicaltrials.gov/ct2/show/NCT01545934, https://clinicaltrials.gov/ct2/show/NCT01616147, https://clinicaltrials.gov/ct2/show/NCT01771133, https://clinicaltrials.gov/ct2/show/NCT01631747, https://clinicaltrials.gov/ct2/show/NCT01768793, https://clinicaltrials.gov/ct2/show/NCT01610752
Study Website: https://lifemoms.bsc.gwu.edu/web/lifemoms
Data Package Version Number: 1 (March 2, 2023)
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 was a network of seven clinical centers and a data coordinating center to identify effective behavioral and lifestyle interventions that improve weight, glycemic control, and outcomes in obese and overweight pregnant women and their children.
Participants were randomized between 9 weeks 0 days and 15 weeks 6 days gestation, and followed through one-year postpartum. Standardized measures were collected throughout gestation: at baseline (9-15 weeks), 24-27 weeks, 35-36 weeks, delivery, and one-year postpartum. Eligibility criteria, specific outcome measures, and assessment procedures were standardized across trials. Measures that were collected in all seven trials were defined as ‘core’ data and measures collected by four to six trials were defined as ‘super-shared’ data. All core and super-shared measures had a standardized definition and/or detailed procedures to facilitate uniform collection, a standardized training and certification process, and were entered into a common dataset at the data coordinating center.
The overall goal of the consortium was to identify effective behavioral and lifestyle interventions that would improve weight, glycemic control, and other pregnancy-related outcomes in obese and overweight pregnant women and determine whether these interventions reduced obesity and metabolic abnormalities in children.
The primary outcome measure was gestational weight gain per week, assessed by serial weight measurements up to 36 weeks gestation. Secondary outcome measures included obstetric outcomes (e.g., gestational hypertension and preeclampsia, gestational diabetes, preterm delivery), maternal one-year postpartum outcomes (e.g., postpartum weight retention), neonatal outcomes (e.g., birth weight, respiratory morbidity, hypoglycemia), and neonatal and infant anthropometrics (e.g., length, skinfold thickness). Site specific measures can be found in the LIFE-Moms Synopses document.
Core inclusion criteria:
Core exclusion criteria:
Site specific inclusion and exclusion criteria can be found in the LIFE-Moms Synopses document.
Pooled findings from the LIFE-Moms consortium found that among the randomized women, the percent with excess gestational weight gain per week as well as overall weight gain from enrollment in early pregnancy to 36 weeks gestation, was significantly lower in the intervention group compared to those in standard care. However, the women in the intervention group still exceeded the Institute of Medicine (IOM) guidelines for weight gain in pregnancy. No differences were found between the intervention and standard care groups for macrosomia, cesarean section, gestational diabetes, and small-for-gestational-age infants.