NCT01954342CompletedNot Applicable
MomEE: Determinants of Gestational Weight Gain in Obese Pregnant Women
Pennington Biomedical Research Center1 site in 1 country72 target enrollmentStarted: December 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Energy Intake
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •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
Outcomes
Primary Outcomes
Energy Intake
Time Frame: 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 Outcomes
- Physical Activity(Approximately 7 days within 35-37 weeks gestation)
- Percentage of Fat of Energy Intake(Approximately 7 days within 35-37 weeks gestation)
- Energy Expenditure During Sleep(1 day within 35-37 weeks gestation)
- Percentage of Carbohydrate of Energy Intake(Approximately 7 days within 35-37 weeks gestation)
- Percentage of Protein of Energy Intake(Approximately 7 days within 35-37 weeks gestation)
Investigators
Leanne Redman
Principal Investigator
Pennington Biomedical Research Center
Study Sites (1)
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