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Determinants of Gestational Weight Gain in Obese Pregnant Women (MomEE)

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ClinicalTrials.gov Identifier: NCT01954342
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Leanne Redman, 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 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.

Condition or disease
Energy Intake Energy Expenditure

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MomEE: Determinants of Gestational Weight Gain in Obese Pregnant Women
Study Start Date : December 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Group/Cohort
Pregnant
Obese pregnant women



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Physical activity [ Time Frame: Approximately 7 days within 13-16 weeks gestation ]
    Physical activity is determined using mean amplitude deviation by wrist worn accelerometer over a period of approximately 7 days within early pregnancy (13-16 weeks gestation).

  2. Physical activity [ Time Frame: Approximately 7 days within 35-37 weeks gestation ]
    Physical activity is determined using mean amplitude deviation by wrist worn accelerometer over a period of approximately 7 days within late pregnancy (35-37 weeks gestation).

  3. Energy expenditure during sleep [ Time Frame: 1 day within 13-16 weeks gestation ]
    Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within early pregnancy (13-16 weeks gestation).

  4. Energy expenditure during sleep [ Time Frame: 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).

  5. Percentage of protein of energy intake [ Time Frame: Approximately 7 days within 13-16 weeks gestation ]
    Percentage of protein of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).

  6. Percentage of protein of energy intake [ Time Frame: 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).

  7. Percentage of fat of energy intake [ Time Frame: Approximately 7 days within 13-16 weeks gestation ]
    Percentage of fat of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).

  8. Percentage of fat of energy intake [ Time Frame: 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).

  9. Percentage of carbohydrate of energy intake [ Time Frame: Approximately 7 days within 13-16 weeks gestation ]
    Percentage of carbohydrate of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).

  10. Percentage of carbohydrate of energy intake [ Time Frame: 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).


Biospecimen Retention:   Samples Without DNA
Placenta, Cord Blood, fasting Urine, fasting Maternal plasma and serum (during pregnancy and postpartum).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
75 obese, pregnant women
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954342


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Leanne M Redman, PhD Pennington Biomedical Research

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leanne Redman, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01954342     History of Changes
Other Study ID Numbers: PBRC 13020
1R01DK099175 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Keywords provided by Leanne Redman, Pennington Biomedical Research Center:
Pregnancy
Postpartum
Additional relevant MeSH terms:
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Weight Gain
Gestational Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms