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Energy IntakeMomEENCT01954342

Determinants of Gestational Weight Gain in Obese Pregnant Women

An observational study of Energy Intake and Energy Expenditure, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Institute of Medicine (IOM) guidelines, 'High Gainers', will have increased energy intake but no evidence for changes in energy… Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Energy Intake, Energy Expenditure
How many people
72 participants
Where
1 siteUnited States
Study dates
Dec 2014to Aug 2018
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: 75 obese, pregnant women

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: 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.

Keywords
Pregnancy, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01954342
Study groupRoleWhat they receive
PregnantObese pregnant women

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Energy Intake

    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.

    Measured: Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)

Secondary outcomes (10)

  1. Physical Activity

    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.

    Measured: Approximately 7 days within 13-16 weeks gestation

  2. Physical Activity

    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.

    Measured: Approximately 7 days within 35-37 weeks gestation

  3. Energy Expenditure During Sleep

    Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within early pregnancy (13-16 weeks gestation).

    Measured: 1 day within 13-16 weeks gestation

  4. Energy Expenditure During Sleep

    Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within late pregnancy (35-37 weeks gestation).

    Measured: 1 day within 35-37 weeks gestation

  5. Percentage of Protein of Energy Intake

    Percentage of protein of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).

    Measured: Approximately 7 days within 13-16 weeks gestation

  6. Percentage of Protein of Energy Intake

    Percentage of protein of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).

    Measured: Approximately 7 days within 35-37 weeks gestation

  7. Percentage of Fat of Energy Intake

    Percentage of fat of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).

    Measured: Approximately 7 days within 13-16 weeks gestation

  8. Percentage of Fat of Energy Intake

    Percentage of fat of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).

    Measured: Approximately 7 days within 35-37 weeks gestation

  9. Percentage of Carbohydrate of Energy Intake

    Percentage of carbohydrate of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).

    Measured: Approximately 7 days within 13-16 weeks gestation

  10. Percentage of Carbohydrate of Energy Intake

    Percentage of carbohydrate of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).

    Measured: Approximately 7 days within 35-37 weeks gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2013 (estimated)
  2. Study startDec 2014
  3. Primary completionJul 2017
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01954342
Sponsor's protocol ID
PBRC 13020
Other IDs
1R01DK099175
Acronym
MomEE
Status last verified
Aug 2021
First submitted
26 Sep 2013
Last updated
16 Sep 2021
Data monitoring committee
No

Publications

  • Lindsay KL, Most J, Buehler K, Kebbe M, Altazan AD, Redman LM. Maternal mindful eating as a target for improving metabolic outcomes in pregnant women with obesity. Front Biosci (Landmark Ed). 2021 Dec 30;26(12):1548-1558. doi: 10.52586/5048.

    PubMed 34994169

  • Most J, Altazan AD, St Amant M, Beyl RA, Ravussin E, Redman LM. Increased Energy Intake After Pregnancy Determines Postpartum Weight Retention in Women With Obesity. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1601-11. doi: 10.1210/clinem/dgz330.

    PubMed 31905403

  • Most J, Amant MS, Hsia DS, Altazan AD, Thomas DM, Gilmore LA, Vallo PM, Beyl RA, Ravussin E, Redman LM. Evidence-based recommendations for energy intake in pregnant women with obesity. J Clin Invest. 2019 Aug 1;129(11):4682-4690. doi: 10.1172/JCI130341.

    PubMed 31369400

  • Most J, Redman LM. Energy expenditure predictions in postpartum women require adjustment for race. Am J Clin Nutr. 2019 Aug 1;110(2):522-524. doi: 10.1093/ajcn/nqz087. No abstract available.

    PubMed 31367759

  • Most J, Vallo PM, Gilmore LA, St Amant M, Hsia DS, Altazan AD, Beyl RA, Ravussin E, Redman LM. Energy Expenditure in Pregnant Women with Obesity Does Not Support Energy Intake Recommendations. Obesity (Silver Spring). 2018 Jun;26(6):992-999. doi: 10.1002/oby.22194.

    PubMed 29797559

  • Most J, Gilmore LA, Altazan AD, St Amant M, Beyl RA, Ravussin E, Redman LM. Propensity for adverse pregnancy outcomes in African-American women may be explained by low energy expenditure in early pregnancy. Am J Clin Nutr. 2018 Jun 1;107(6):957-964. doi: 10.1093/ajcn/nqy053.

    PubMed 29767680

  • Most J, Vallo PM, Altazan AD, Gilmore LA, Sutton EF, Cain LE, Burton JH, Martin CK, Redman LM. Food Photography Is Not an Accurate Measure of Energy Intake in Obese, Pregnant Women. J Nutr. 2018 Apr 1;148(4):658-663. doi: 10.1093/jn/nxy009.

    PubMed 29659958

  • Sutton EF, Cain LE, Vallo PM, Redman LM. Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials. Obstet Gynecol. 2017 Mar;129(3):554-559. doi: 10.1097/AOG.0000000000001900.

    PubMed 28178062

Questions about this trial

What is this clinical trial studying?

An observational study of Energy Intake and Energy Expenditure, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Energy Intake (time frame: Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01954342, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.

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