CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 281 enrolled
Drug / intervention
Lifestyle Intervention Group +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01631747
NCT01631747N/ACompleted

Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)

Northwestern University·interventional·Posted Jun 29, 2012·Updated Nov 6, 2018

In Brief

A clinical study evaluating Lifestyle Intervention Group and Usual Care Group for Pregnancy and Weight Gain. Completed, enrolled 281 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 29, 2012
Enrollment StartNov 1, 2012
Primary CompletionJul 31, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.0 years ago

Interventions

Lifestyle Intervention Groupbehavioral

Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet \& activity and use of pedometer

Usual Care Groupbehavioral

Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.