Maternal-Offspring Metabolics:Family Intervention Trial — MOMFIT  

Pregnancy Clinical Trial

Official title: Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)

Status Completed

Clinical Trial Summary

The prevalence of maternal overweight and obesity has nearly doubled in the United States since 1976. In 2004-2005, 42% of pregnant women had body mass index (BMI) above 25 versus 23% in 1993. Most American women are overweight/ obese (OW/OB) at conception, especially within certain racial, ethnic, and lower socioeconomic groups leading to increased adverse maternal and birth outcomes. This study will recruit, randomize and test in 300 ethnically diverse OW/OB pregnant women a behavioral intervention aimed at controlling gestational weight gain (GWG) through recommended diet, activity and lifestyle changes that are to be maintained postpartum. Outcomes include anthropometric (height, weight, percent body fat) metabolic (blood pressure, fasting glucose, insulin, HbA1c, lipids and C-reactive protein) and behavioral measures (diet. physical activity, sleep and stress). In addition, babies will be measured for length, weight and percent body fat. The goal is to limit excessive gestational weight gain through improved maternal lifestyle that can be maintained and modelled for the family post partum and beyond.

Clinical Trial Description

A Randomized Control Trial is planned among ethnically diverse OW/OB pregnant women ages 18-45 years to be randomly assigned to the MOMFIT Active Intervention Group (AIG) or the Educational Control Group (ECG) plus standard obstetrical care. The Dietary Approaches to Stop Hypertension (DASH) diet, along with moderate physical activity and group intervention as utilized in the Diabetes Prevention Program (DPP), will be adapted for pregnant and postpartum women through individual visits to tailor calorie/nutrient/activity goals, plus group coaching sessions and electronic self-monitoring behavior. Evidence based motivational interviewing and state of the art self-monitoring tools involving the LoseIt app will be adapted for pregnant/postpartum women via smartphone or Internet access, along with tailored feedback and encouragement from the Lifestyle Coach. Prevention of excessive GWG and achievement of the Institute Of Medicine (IOM) weight gain goals will be compared between groups, whether ongoing adherence to the lifestyle interventions can be sustained through postpartum intervention. Approximately one third of the participants are expected to be minorities and/or from low income backgrounds. The primary outcome is gestational weight gain from baseline (self-reported prepregnancy weight) to near delivery (36 weeks) compared with IOM goals in both groups and postpartum weight retention between 6 weeks and 12 months postpartum. Additional outcome variables include changes in maternal Body Mass Index (BMI) and adiposity postpartum, blood pressure, blood glucose, insulin, Hemoglobin A1c (HbA1c), C-reactive Protein (CRP), and lipids, diet quality, and physical activity levels, offspring adiposity and anthropometrics, and glucose and C-peptide in cord blood ;

Related Conditions & MeSH terms

• Pregnancy
• Weight Gain

• NCT number: NCT01631747
• Study type: Interventional
• Source: Northwestern University
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Completion date: July 31, 2017