Determinants of Gestational Weight Gain in Obese Pregnant Women

Completed

Conditions: Energy Intake
Energy Expenditure

Registration Number: NCT01954342

Lead Sponsor: Pennington Biomedical Research Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 72

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Energy Intake	Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)	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.

Secondary Outcome Measures

Name	Time	Method
Physical Activity	Approximately 7 days within 35-37 weeks gestation	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.
Percentage of Fat of Energy Intake	Approximately 7 days within 35-37 weeks gestation	Percentage of fat of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).
Energy Expenditure During Sleep	1 day within 35-37 weeks gestation	Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within late pregnancy (35-37 weeks gestation).
Percentage of Carbohydrate of Energy Intake	Approximately 7 days within 35-37 weeks gestation	Percentage of carbohydrate of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).
Percentage of Protein of Energy Intake	Approximately 7 days within 35-37 weeks gestation	Percentage of protein of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).