Maternal-Offspring Metabolics:Family Intervention Trial

Completed · Not applicable

Conditions studied: Pregnancy, Weight Gain

In brief

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.

Key facts

Study ID

NCT01631747

Run by

Northwestern University

People needed

281

Starts

2012-11-01

Expected to finish

2017-07-31

Last updated by the study team

2018-11-06

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-45 years
• Singleton viable pregnancy. A twin pregnancy reduced to singleton before 14 weeks by project gestational age. An ultrasound must be conducted before randomization that shows a fetal heartbeat; there should be no evidence of more than one fetus on the most recent pre-randomization ultrasound.
• Gestational age at randomization no earlier than 9 weeks 0 days and no later than 15 weeks 6 days based on an algorithm (see Section 3.4.3 below) that compares the last menstrual period (LMP) date and data from the earliest ultrasound
• Body mass index between 25-35 kg/m2 based on first trimester measured weight and on measured height. The earliest weight measurement before randomization, measured specifically for the study will be used.

You may not qualify if…

• In vitro fertilization (IVF) conception/ovulation induction w/ gonadotropins
• Weight gain of >15 pounds from reported prepregnancy weight to Baseline visit
• Current smoker
• Prior bariatric surgery
• In weight loss program w/in 3 months of conception
• History of alcohol or drug abuse within 5 years
• No access to internet and/or smartphone
• Unable to attend intervention/follow-up visits
• Unwilling/unable to commit to self-monitoring data collection
• Unable to complete intervention program
• Presence of any condition that limits walking or following diet recommendations
• Not fluent in English

Where it is running

• Northwestern Memorial Hospital; Prentice Women's — Chicago, Illinois, United States
• Northwestern University: Dept of Preventive Medicine — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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