- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01954342
Determinants of Gestational Weight Gain in Obese Pregnant Women (MomEE)
23 augusti 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
72
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70808
- Pennington Biomedical Research Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 40 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Testmetod
Icke-sannolikhetsprov
Studera befolkning
75 obese, pregnant women
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Pregnant
Obese pregnant women
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Energy Intake
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Physical Activity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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).
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Approximately 7 days within 35-37 weeks gestation
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Leanne M Redman, PhD, Pennington Biomedical Research
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2014
Primärt slutförande (Faktisk)
1 juli 2017
Avslutad studie (Faktisk)
1 augusti 2018
Studieregistreringsdatum
Först inskickad
26 september 2013
Först inskickad som uppfyllde QC-kriterierna
26 september 2013
Första postat (Uppskatta)
1 oktober 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 september 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 augusti 2021
Senast verifierad
1 augusti 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PBRC 13020
- 1R01DK099175 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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