Determinants of Gestational Weight Gain in Obese Pregnant Women (MomEE)
23. srpna 2021 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Pozorovací
Zápis (Aktuální)
72
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Louisiana
-
Baton Rouge, Louisiana, Spojené státy, 70808
- Pennington Biomedical Research Center
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 40 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Ženský
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
75 obese, pregnant women
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
Pregnant
Obese pregnant women
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Energy Intake
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Physical Activity
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Leanne M Redman, PhD, Pennington Biomedical Research
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. prosince 2014
Primární dokončení (Aktuální)
1. července 2017
Dokončení studie (Aktuální)
1. srpna 2018
Termíny zápisu do studia
První předloženo
26. září 2013
První předloženo, které splnilo kritéria kontroly kvality
26. září 2013
První zveřejněno (Odhad)
1. října 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
16. září 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. srpna 2021
Naposledy ověřeno
1. srpna 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PBRC 13020
- 1R01DK099175 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .