Determinants of Gestational Weight Gain in Obese Pregnant Women

NCT ID: NCT01954342

Last Updated: 2021-09-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Energy Intake Energy Expenditure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant

Obese pregnant women

No interventions assigned to this group

Eligibility Criteria

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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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Leanne Redman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leanne M Redman, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34994169 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31905403 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31369400 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31367759 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29797559 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29767680 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29659958 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28178062 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://labs.pbrc.edu/womenshealth/research.htm

Reproductive Endocrinology \& Women's Health Laboratory- Our Research

Other Identifiers

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1R01DK099175

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PBRC 13020

Identifier Type: -

Identifier Source: org_study_id

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