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Trial record 1 of 1 for:    MomEE
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Determinants of Gestational Weight Gain in Obese Pregnant Women (MomEE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01954342
First received: September 26, 2013
Last updated: August 4, 2017
Last verified: August 2017
  Purpose
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
Energy Intake Energy Expenditure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MomEE: Determinants of Gestational Weight Gain in Obese Pregnant Women

Resource links provided by NLM:


Further study details as provided by Leanne Redman, Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Energy intake [ Time Frame: 18 months (pregnancy to 12 months postpartum) ]
  • Free living energy expenditure and sleeping metabolic rate [ Time Frame: 18 months (pregnancy to 12 months postpartum) ]

Secondary Outcome Measures:
  • Measurement of changes in physical activity [ Time Frame: 18 months (pregnancy to 12 months postpartum) ]
  • Measurement of changes in substrate oxidation [ Time Frame: 18 months (pregnancy to 12 months postpartum) ]
  • Determinants of energy intake including fasting concentrations of leptin, total ghrelin, peptide YY, cholecystokinin [ Time Frame: 18 months (pregnancy to 12 months postpartum) ]
  • Determinants of energy expenditure including urinary epinephrine and norepinephrine, fasting concentrations of T3, T4, and TSH [ Time Frame: 18 months (pregnancy to 12 months postpartum) ]

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

Estimated Enrollment: 75
Study Start Date: December 2014
Estimated Study Completion Date: August 2018
Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant
Obese pregnant women

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954342

Locations
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
Principal Investigator: Leanne M Redman, PhD Pennington Biomedical Research
  More Information

Additional Information:
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 )
Study First Received: September 26, 2013
Last Updated: August 4, 2017

Keywords provided by Leanne Redman, Pennington Biomedical Research Center:
Pregnancy
Postpartum

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 21, 2017