Determinants of Gestational Weight Gain in Obese Pregnant Women
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 2/27/2019 |
| Start Date: | December 2014 |
| End Date: | August 2018 |
MomEE: Determinants of Gestational Weight Gain in Obese Pregnant Women
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
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.
pregnancy. The investigators hypothesize that obese pregnant women with weight gain above the
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.
Inclusion Criteria:
- Are pregnant
- Have a 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. SBP >160 mmHg & 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 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 ADHD including amphetamines and
methylphenidate
- Continued use of weight loss medication including 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
We found this trial at
1
site
6400 Perkins Rd
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
(225) 763-2500
Principal Investigator: Leanne M Redman, PhD
Phone: 225-763-2725
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