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Completed

NCT Number: NCT01954342

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 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.

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Key information

Conditions

Energy Intake Energy Expenditure

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Physical Activity

    Time frame: Approximately 7 days within 13-16 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 early pregnancy (13-16 weeks gestation). Mean amplitude deviation describes the mean distance of data points from the mean, and higher values denote higher levels of physical activity.

  2. Physical Activity

    Time frame: 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.

  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).

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

MomEE: Determinants of Gestational Weight Gain in Obese Pregnant Women

Acronym: MomEE

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Oct 1, 2013
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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