Maternal-Offspring Metabolics:Family Intervention Trial

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pregnancy, Weight Gain

Intervention / Treatment
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* Behavioral: Lifestyle Intervention Group
* Behavioral: Usual Care Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Group<br>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. | Behavioral: Usual Care Group<br>* 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.<br>|
| Experimental: Lifestyle Intervention Group<br>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 | Behavioral: Lifestyle Intervention Group<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Fasting Glucose | Blood will be collected at Baseline and 35-37 weeks. | 14-37 wks | 
| High-density Lipoprotein (HDL) | Blood will be collected at Baseline and 35-37 weeks. | 14-37 wks | 
| Low-density Lipoprotein (LDL) | Blood will be collected at Baseline and 35-37 weeks. | 14-37 weeks | 
| Total Cholesterol | Blood will be collected at Baseline and 35-37 weeks. | 14-37 Weeks | 
| Triglycerides | Blood will be collected at Baseline and 35-37 weeks. | 14-37 Weeks | 
| Leptin | Blood will be collected at Baseline and 35-37 weeks. | 14-37 weeks | 
| 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 | 
| 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 | 
| 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 | 
| Birth Weight | Neonatal Body measurements | Delivery | 
| Birth Length | Neonate birth measures | Delivery | 
| Head Circumference | Neonate birth measures | Delivery | 
| Neonate Percent Body Fat | Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system. | Delivery | 
| Infant Weight | Infant Body measurements | 1 year | 
| Infant Length | Infant body measurement | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Weight gain, Obesity, Pregnancy and weight gain