Maternal-Offspring Metabolics:Family Intervention Trial

Pregnancy Clinical Trial

— MOMFIT  

Official title:

Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631747
• Other study ID #: DK10-014
• Secondary ID: 1U01HL114344-01
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: July 31, 2017

Study information

• Verified date: October 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Pregnancy
• Weight Gain

Intervention

Behavioral:
• Lifestyle Intervention Group
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 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.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital; Prentice Women's	Chicago	Illinois
United States	Northwestern University: Dept of Preventive Medicine	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational Weight Gain (GWG)	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.	14-37 weeks
Secondary	Percentage of Participants With Gestational Diabetes	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.	24-26 weeks
Secondary	Fasting Glucose	Blood will be collected at Baseline and 35-37 weeks.	14-37 wks
Secondary	High-density Lipoprotein (HDL)	Blood will be collected at Baseline and 35-37 weeks.	14-37 wks
Secondary	Low-density Lipoprotein (LDL)	Blood will be collected at Baseline and 35-37 weeks.	14-37 weeks
Secondary	Total Cholesterol	Blood will be collected at Baseline and 35-37 weeks.	14-37 Weeks
Secondary	Triglycerides	Blood will be collected at Baseline and 35-37 weeks.	14-37 Weeks
Secondary	Leptin	Blood will be collected at Baseline and 35-37 weeks.	14-37 weeks
Secondary	Steady State Beta Cell Function	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).	baseline (14 weeks) and 35-37 weeks
Secondary	Insulin Sensitivity	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.	baseline(14 weeks) and 35-37 weeks
Secondary	Insulin Resistance (IR)	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.	Baseline (14 weeks) and 35 weeks
Secondary	Birth Weight	Neonatal Body measurements	Delivery
Secondary	Birth Length	Neonate birth measures	Delivery
Secondary	Head Circumference	Neonate birth measures	Delivery
Secondary	Neonate Percent Body Fat	Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.	Delivery
Secondary	Infant Weight	Infant Body measurements	1 year
Secondary	Infant Length	Infant body measurement	1 year