Determinants of Gestational Weight Gain in Obese Pregnant Women (MomEE)
23 augustus 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Observationeel
Inschrijving (Werkelijk)
72
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Louisiana
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Baton Rouge, Louisiana, Verenigde Staten, 70808
- Pennington Biomedical Research Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 40 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
75 obese, pregnant women
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Pregnant
Obese pregnant women
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Energy Intake
Tijdsspanne: Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)
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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.
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Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Physical Activity
Tijdsspanne: Approximately 7 days within 13-16 weeks gestation
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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.
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Approximately 7 days within 13-16 weeks gestation
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Physical Activity
Tijdsspanne: Approximately 7 days within 35-37 weeks gestation
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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.
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Approximately 7 days within 35-37 weeks gestation
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Energy Expenditure During Sleep
Tijdsspanne: 1 day within 13-16 weeks gestation
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Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within early pregnancy (13-16 weeks gestation).
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1 day within 13-16 weeks gestation
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Energy Expenditure During Sleep
Tijdsspanne: 1 day within 35-37 weeks gestation
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Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within late pregnancy (35-37 weeks gestation).
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1 day within 35-37 weeks gestation
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Percentage of Protein of Energy Intake
Tijdsspanne: Approximately 7 days within 13-16 weeks gestation
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Percentage of protein of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).
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Approximately 7 days within 13-16 weeks gestation
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Percentage of Protein of Energy Intake
Tijdsspanne: Approximately 7 days within 35-37 weeks gestation
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Percentage of protein of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).
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Approximately 7 days within 35-37 weeks gestation
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Percentage of Fat of Energy Intake
Tijdsspanne: Approximately 7 days within 13-16 weeks gestation
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Percentage of fat of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).
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Approximately 7 days within 13-16 weeks gestation
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Percentage of Fat of Energy Intake
Tijdsspanne: Approximately 7 days within 35-37 weeks gestation
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Percentage of fat of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).
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Approximately 7 days within 35-37 weeks gestation
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Percentage of Carbohydrate of Energy Intake
Tijdsspanne: Approximately 7 days within 13-16 weeks gestation
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Percentage of carbohydrate of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation).
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Approximately 7 days within 13-16 weeks gestation
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Percentage of Carbohydrate of Energy Intake
Tijdsspanne: Approximately 7 days within 35-37 weeks gestation
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Percentage of carbohydrate of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation).
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Approximately 7 days within 35-37 weeks gestation
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Leanne M Redman, PhD, Pennington Biomedical Research
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 december 2014
Primaire voltooiing (Werkelijk)
1 juli 2017
Studie voltooiing (Werkelijk)
1 augustus 2018
Studieregistratiedata
Eerst ingediend
26 september 2013
Eerst ingediend dat voldeed aan de QC-criteria
26 september 2013
Eerst geplaatst (Schatting)
1 oktober 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 september 2021
Laatste update ingediend die voldeed aan QC-criteria
23 augustus 2021
Laatst geverifieerd
1 augustus 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PBRC 13020
- 1R01DK099175 (Subsidie/contract van de Amerikaanse NIH)
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