Maternal-Offspring Metabolics:Family Intervention Trial

Not Applicable

Completed

• Conditions: Weight Gain; Pregnancy
• Interventions: Behavioral: Usual Care Group; Behavioral: Lifestyle Intervention Group

• Registration Number: NCT01631747
• Lead Sponsor: Northwestern University

Brief 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.

Detailed 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-29
• Study Start: 2012-11
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Results First Submitted: 2018-07-26
• Results First Submitted QC: 2018-08-24
• Results First Posted: 2018-09-25
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-13
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 281

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Group	Usual Care Group	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.
Lifestyle Intervention Group	Lifestyle Intervention Group	Women in the Intervention group will participate in a lifestyle program based on Moms'adopting a healthier diet and becoming more active for 24 months. Implementation is at approximately 15 weeks.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

Primary Outcome Measures

Name	Time	Method
Gestational Weight Gain (GWG)	14-37 weeks	The primary outcome is GWG as assessed continuously by the difference between the maternal weight measured at the baseline and at the 35-37 week visit.

Secondary Outcome Measures

Name	Time	Method
Steady State Beta Cell Function	baseline (14 weeks) and 35-37 weeks	Insulin resistance will be measured with the assistance of a computer program (HOMA Calculator v2.2.3, Diabetic Trial Unit, University of Oxford) which uses blood Glucose and Insulin measures to yield the Homeostatic Model Assessment (HOMA) Steady State beta cell function (%B). 100% is set at normal reference. Should not be interpreted alone, but in combination with Insulin Sensitivity (%S).
Insulin Resistance (IR)	Baseline (14 weeks) and 35 weeks	Insulin resistance will be measured with the assistance of a computer program (HOMA Calculator v2.2.3, Diabetic Trial Unit, University of Oxford) which uses blood Glucose and Insulin measures to yield the Homeostatic Model Assessment (HOMA) Insulin Resistance. HOMA IR (insulin resistance) is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (100/%S); Lower IR is better.; Note: estimates are model-derived, and not linear approximations.
Birth Length	Delivery	Neonate birth measures
Percentage of Participants With Gestational Diabetes	24-26 weeks	Oral Glucose Tolerance Test (OGTT) will be administered at 24-26wks, as part of routine obstetric visit. Difference in incidence of Gestational diabetes between study groups will be documented.
Fasting Glucose	14-37 wks	Blood will be collected at Baseline and 35-37 weeks.
Low-density Lipoprotein (LDL)	14-37 weeks	Blood will be collected at Baseline and 35-37 weeks.
Leptin	14-37 weeks	Blood will be collected at Baseline and 35-37 weeks.
Head Circumference	Delivery	Neonate birth measures
Birth Weight	Delivery	Neonatal Body measurements
Neonate Percent Body Fat	Delivery	Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.
High-density Lipoprotein (HDL)	14-37 wks	Blood will be collected at Baseline and 35-37 weeks.
Infant Weight	1 year	Infant Body measurements
Total Cholesterol	14-37 Weeks	Blood will be collected at Baseline and 35-37 weeks.
Triglycerides	14-37 Weeks	Blood will be collected at Baseline and 35-37 weeks.
Insulin Sensitivity	baseline(14 weeks) and 35-37 weeks	Insulin resistance will be measured with the assistance of a computer program which will yield the Homeostatic Model Assessment (HOMA) Insulin Sensitivity (%S). 100% is equivalent to the normal reference, but needs to be interpreted in context of %B.
Infant Length	1 year	Infant body measurement

Trial Locations

Locations (2)

Northwestern Memorial Hospital; Prentice Women's; 🇺🇸 Chicago, Illinois, United States

Northwestern University: Dept of Preventive Medicine; 🇺🇸 Chicago, Illinois, United States