- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01954342
Determinants of Gestational Weight Gain in Obese Pregnant Women (MomEE)
23. august 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
72
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70808
- Pennington Biomedical Research Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
75 obese, pregnant women
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Pregnant
Obese pregnant women
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Energy Intake
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Physical Activity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Percentage of Carbohydrate of Energy Intake
Tidsramme: 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
|
|
Percentage of Carbohydrate of Energy Intake
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Leanne M Redman, PhD, Pennington Biomedical Research
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. december 2014
Primær færdiggørelse (Faktiske)
1. juli 2017
Studieafslutning (Faktiske)
1. august 2018
Datoer for studieregistrering
Først indsendt
26. september 2013
Først indsendt, der opfyldte QC-kriterier
26. september 2013
Først opslået (Skøn)
1. oktober 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PBRC 13020
- 1R01DK099175 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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