Determinants of Gestational Weight Gain in Obese Pregnant Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure energy intake and energy expenditure during and after pregnancy. The investigators hypothesize that obese pregnant women with weight gain above the Institute of Medicine (IOM) guidelines, 'High Gainers', will have increased energy intake but no evidence for changes in energy expenditure after adjustment for the weight gained when compared to women with appropriate gestational weight gain, 'Normal Gainers'. Additionally, the investigators will measure the babies born to the pregnant women enrolled in MomEE at one time point before 10 days of life.

Official Title
-----------------
MomEE: Determinants of Gestational Weight Gain in Obese Pregnant Women

Conditions
-----------------
Energy Intake, Energy Expenditure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are pregnant Have a body mass index (BMI) greater than or equal to 30kg/m2 Are 18-40 years old Medically cleared for participation by primary care obstetrician Medically cleared for participant by Medical Investigator Willingness to allow the study access to information in the participant's medical record Willingness to be notified of incidental findings from study procedures Exclusion Criteria: Clinical Hypertension (i.e. systolic blood pressure (SBP) >160 mmHg & diastolic blood pressure (DBP) >110 mmHg)* Diagnosis of diabetes prior to pregnancy Hb A1c ≥6.5 %* Implanted metal objects that render MRI unsafe HIV or AIDS (self-reported) Severe anemia (hemoglobin <8g/dL and/or hematocrit <24%)** Psychological History or current psychotic disorder or diagnosis of a current major depressive episode or bipolar disorder Past history of anorexia or bulimia by medical history or patient report (binge eating disorder is not an exclusion) or current eating disorder Actively suicidal defined as a value ≥2 on the Beck Depression Index (BDI-II) question 9* Medications Current use of one or more of the following medications: metformin, systemic steroids, antipsychotic agents (e.g., Abilify, Haldol, Risperdal, Seroquel, Zyprexa), anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight (e.g., Depakote, Lamictal, Lithium, Neurontin, Tegretol, Topamax, Keppra), medications for attention-deficit/hyperactivity disorder (ADHD) including amphetamines and methylphenidate Continued use of weight loss medication including over the counter (OTC) and dietary supplements for weight loss (e.g., Adipex, Suprenza, Tenuate, Xenical, Alli, conjugated linoleic acid, Hoodia, Green tea extract, Guar gum, HydroxyCut, Sensa, Corti-slim, Chromium, chitosan, Bitter orange) Other Exclusion Criteria Recent history of or currently smoking, drinking alcohol or abusing drugs (prescription or recreational) Plans to move out of the study area within the next 2 years or plans to be out of the study area for more than 4 weeks in the next 12 months Planned termination of pregnancy Unwillingness to avoid pregnancy for 12 months following delivery Claustrophobia Prior or planned (within 1 year of expected delivery) bariatric surgery Participant's unwillingness or inability to commit to a 1 year follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant<br>Obese pregnant women | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy Intake | Energy intake is determined using the energy intake-balance method. Energy intake was calculated as the sum of energy expenditure by doubly labeled water and energy deposition of fat and fat-free tissues by 3 compartment model using plethysmography and isotope dilution. | Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | Physical activity is determined using daily mean amplitude deviation in milligrams by wrist worn accelerometer over a period of approximately 7 days within early pregnancy (13-16 weeks gestation). Mean amplitude deviation describes the mean distance of data points from the mean, and higher values denote higher levels of physical activity. | Approximately 7 days within 13-16 weeks gestation | 
| Physical Activity | Physical activity is determined using daily mean amplitude deviation in milligrams by wrist worn accelerometer over a period of approximately 7 days within late pregnancy (35-37 weeks gestation). Mean amplitude deviation describes the mean distance of data points from the mean, and higher values denote higher levels of physical activity. | Approximately 7 days within 35-37 weeks gestation | 
| Energy Expenditure During Sleep | Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within early pregnancy (13-16 weeks gestation). | 1 day within 13-16 weeks gestation | 
| Energy Expenditure During Sleep | Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within late pregnancy (35-37 weeks gestation). | 1 day within 35-37 weeks gestation | 
| Percentage of Protein of Energy Intake | Percentage of protein of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation). | Approximately 7 days within 13-16 weeks gestation | 
| Percentage of Protein of Energy Intake | Percentage of protein of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation). | Approximately 7 days within 35-37 weeks gestation | 
| Percentage of Fat of Energy Intake | Percentage of fat of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation). | Approximately 7 days within 13-16 weeks gestation | 
| Percentage of Fat of Energy Intake | Percentage of fat of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation). | Approximately 7 days within 35-37 weeks gestation | 
| Percentage of Carbohydrate of Energy Intake | Percentage of carbohydrate of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation). | Approximately 7 days within 13-16 weeks gestation | 
| Percentage of Carbohydrate of Energy Intake | Percentage of carbohydrate of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation). | Approximately 7 days within 35-37 weeks gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpartum, Pregnancy