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Determinants of Gestational Weight Gain in Obese Pregnant Women (MomEE)

23. August 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

72

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Louisiana
      • Baton Rouge, Louisiana, Vereinigte Staaten, 70808
        • Pennington Biomedical Research Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 40 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

75 obese, pregnant women

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Pregnant
Obese pregnant women

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Energy Intake
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Physical Activity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Leanne M Redman, PhD, Pennington Biomedical Research

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Dezember 2014

Primärer Abschluss (Tatsächlich)

1. Juli 2017

Studienabschluss (Tatsächlich)

1. August 2018

Studienanmeldedaten

Zuerst eingereicht

26. September 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. September 2013

Zuerst gepostet (Schätzen)

1. Oktober 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. September 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. August 2021

Zuletzt verifiziert

1. August 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • PBRC 13020
  • 1R01DK099175 (US NIH Stipendium/Vertrag)

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