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

August 23, 2021 updated by: Leanne Redman, Pennington Biomedical Research Center

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 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

75 obese, pregnant women

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Pregnant
Obese pregnant women

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Approximately 7 days within 13-16 weeks gestation
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.
Approximately 7 days within 35-37 weeks gestation
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).
1 day within 13-16 weeks gestation
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).
1 day within 35-37 weeks gestation
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).
Approximately 7 days within 13-16 weeks gestation
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).
Approximately 7 days within 35-37 weeks gestation
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).
Approximately 7 days within 13-16 weeks gestation
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).
Approximately 7 days within 35-37 weeks gestation
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).
Approximately 7 days within 13-16 weeks gestation
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).
Approximately 7 days within 35-37 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pennington Biomedical Research Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leanne M Redman, PhD, Pennington Biomedical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBRC 13020
  • 1R01DK099175 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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