Determinants of Gestational Weight Gain in Obese Pregnant Women
NCT ID: NCT01954342
Last Updated: 2021-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
72 participants
OBSERVATIONAL
2014-12-31
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
* 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
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Pennington Biomedical Research Center
OTHER
Responsible Party
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Leanne Redman
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
Countries
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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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Reproductive Endocrinology \& Women's Health Laboratory- Our Research
Other Identifiers
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PBRC 13020
Identifier Type: -
Identifier Source: org_study_id
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