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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

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

    • Louisiana
      • Baton Rouge, Louisiana, Förenta staterna, 70808
        • Pennington Biomedical Research Center

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
Pregnant
Obese pregnant women

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Energy Intake
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physical Activity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
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).
Approximately 7 days within 35-37 weeks gestation

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

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

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

Andra studie-ID-nummer

  • PBRC 13020
  • 1R01DK099175 (U.S.S. NIH-anslag/kontrakt)

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