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Effects of Obesity and Physical Inactivity on Pregnancy Outcomes

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ClinicalTrials.gov Identifier: NCT02039414
Recruitment Status : Completed
First Posted : January 17, 2014
Results First Posted : June 7, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Regular maternal physical activity leads to the delivery of lighter, leaner infants. Higher birth weights and childhood obesity are both strong predictors for adult obesity, suggesting that the impact of maternal physical activity on the future health of a child is substantial. However, the mechanisms underlying the relationships between maternal physical activity and improved infant outcomes are unclear. Thus, the purpose of this project is to measure two potential contributing factors: maternal fat metabolism and maternal oxidative stress profiles. The investigators believe that maternal physical activity leads to beneficial alterations in maternal fat metabolism and oxidative stress profiles. Further, the investigators believe that both maternal fat metabolism and oxidative stress levels are related to infant outcomes such as obesity and insulin resistance. Therefore, exercise will improve maternal metabolic factors that can lead to improvements in infant outcomes. The investigators will compare these factors between obese inactive pregnant women and obese active pregnant women. This study design will allow us not only to determine the effect of physical activity on maternal and neonatal pregnancy outcomes, but also to establish whether obesity or physical inactivity should be a primary area of focus when prescribing pregnancy interventions in clinical practice.

Condition or disease
Obesity Sedentary

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Effects of Physical Activity on Maternal Lipid Metabolism, Oxidative Stress, and Neonatal Outcomes in Obese Pregnancy
Study Start Date : October 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : December 2015

Group/Cohort
Obese, Inactive
Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
Obese, Active
Pregnant women with a BMI≥30kg/m2 and exercising >150min/week



Primary Outcome Measures :
  1. Neonatal Adiposity [ Time Frame: 24-48 hr after delivery ]
    Within 48 hours of delivery, neonatal body composition (% fat mass) will be measured by skin fold thickness measurement and by air displacement plethysmography (Pea Pod, Life Measurement, Inc., Concord, CA) in the CRU at WUSM.

  2. Neonatal Insulin Resistance [ Time Frame: Immediately after delivery ]
    Infant HOMA-IR will be determined by measuring umbilical cord plasma glucose and insulin concentrations at parturition vis cord blood collection. Cord blood will be collected within 30 min of delivery, centrifuged for 10 min at 3000rpm to remove plasma, and stored at -80.


Secondary Outcome Measures :
  1. Maternal Inflammation [ Time Frame: This was taken while fasted and under resting conditions at the beginning of visit 2 (between 32 and 37 weeks gestation). This value was only measured at baseline (i.e. one timepoint). ]
    High-Sensitivity C-reactive protein was measured.

  2. Maternal Lipid Oxidation [ Time Frame: Visit 2 (32-37 weeks gestation)- reported lipid oxidation is the average of lipid oxidation over the course of the 30min exercise bout (i.e. data collected at minutes 8-10, minutes 18-20, and minutes 28-30 of exercise, all averaged together). ]
    The investigators will measure maternal lipid oxidation rate using indirect calorimetry (True One 2400, Parvo Medics, Sandy, UT) before, during, and after acute exercise. This will involve placing a hoodlike device over the subject's head as they lay supine (rest).During exercise, this involved using a mouthpiece and noseclips. Using both techniques, The investigators will be able to calculate lipid oxidation rates from the volumes of CO2 produced and volumes of O2 used.The reported measure is lipid oxidation rate during exercise. The equation used to calculate lipid oxidation is: lipid oxidation (g/min) = 1.695 VO2- 1.701 VCO2 .


Biospecimen Retention:   Samples Without DNA
The investigators are collecting maternal blood at 7 different time points (all in one day/visit) during the 3rd trimester of thier pregnancy. The investigators are also collecting cord blood when the babies are born. All of these samples are stored at -80 with patient identification numbers.


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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All women who seek pre-natal care at the Women's Health Clinic at Barnes Jewish Hospital/Washington University will be screened for inclusion BMI by history at the clinic. Subjects will be recruited late in their 2nd trimester at the women's health clinic after asking about their exercise habits. All patients who meet criterion with on-going pregnancies will be approached for enrollment in the study. This study will compare 2 groups of pregnant women between 32 and 37 weeks gestation. The first group will inactive obese women and the other will be active obese women. We will recruit 15 subjects per group (N=30). Groups will be race-matched.
Criteria

Inclusion Criteria:

  • . Age 18-44 2. Confirmed singleton viable pregnancy with no fetal abnormalities at routine 18-22 ultrasonography 3. Obese: Pre-pregnancy BMI between 30 and 45 kg/m2 4. Receipt of prenatal care and plans to deliver at Barnes-Jewish Hospital 5. Inactive: < 30min of low intensity activity (>1.5 METS) all or most days of the week Physically Active: >150 minutes/week of moderate to high intensity activity 6. Completion of a normal routine, standard of care 1 hour 50 gram gestational diabetes screen

Exclusion Criteria:

  1. Multiple gestation pregnancy
  2. Inability to provide voluntary informed consent
  3. Current use of illegal drugs (cocaine, methamphetamine, opiates, etc…)
  4. Current smoker who does not consent to cessation
  5. Current usage of daily medications by class: corticosteroids, anti-psychotics (known to alter insulin resistance and metabolic profiles)
  6. History of gestational diabetes, pre-pregnancy diabetes or prior macrosomic (>4500g) infant (each elevate the risk for gestational diabetes in the current pregnancy, or undiagnosed gestational diabetes)
  7. History of heart disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039414


Locations
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United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: William T Cade, PT, PhD Washington University School of Medicine
Publications:
Catalano, P. M. (2010).
Sen, S. and R. A. Simmons
Pomeroy, J., et al. (2013).
Thompson, W.R. (2010) ACSM's Guidelines for Exercise Testing and Perscription. 8th edition. Philadelphia, PN: Lippencott Williams & Wilkins
Vioque, J., et al. (2013).

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02039414    
Other Study ID Numbers: 201306109
TL1TR000449 ( U.S. NIH Grant/Contract )
First Posted: January 17, 2014    Key Record Dates
Results First Posted: June 7, 2016
Last Update Posted: August 22, 2016
Last Verified: July 2016
Keywords provided by Washington University School of Medicine:
Obesity
Physical Inactivity
Lipid Oxidation
Oxidative stress
pregnancy
neonatal adiposity
neonatal insulin sensitivity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight