Effects of Obesity and Physical Inactivity on Pregnancy Outcomes

NCT02039414 | Completed Results DMC

• 2 other identifiers: 201306109TL1TR000449
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Sedentary

Keywords

Obesity; Physical Inactivity; Lipid Oxidation; Oxidative stress; pregnancy; neonatal adiposity; neonatal insulin sensitivity

Outcome Measures

Primary Outcomes (2)

• Neonatal Adiposity

  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.

  24-48 hr after delivery

• Neonatal Insulin Resistance

  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.

  Immediately after delivery

Secondary Outcomes (2)

• Maternal Inflammation

  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).

• Maternal Lipid Oxidation

  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).

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Multiple gestation pregnancy
• Inability to provide voluntary informed consent
• Current use of illegal drugs (cocaine, methamphetamine, opiates, etc…)
• Current smoker who does not consent to cessation
• Current usage of daily medications by class: corticosteroids, anti-psychotics (known to alter insulin resistance and metabolic profiles)
• 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)
• History of heart disease.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63108, United States

Location

Related Publications (36)

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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.

MeSH Terms

Conditions

Obesity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Rachel Tinius, Assistant Professor
• Organization: Western Kentucky University

rachel.tinius@wku.edu

2707455026

Study Officials

• William T Cade, PT, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 17, 2014
• Study Start: October 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 22, 2016
• Results First Posted: June 7, 2016

Record last verified: 2016-07

Locations

US (1)