N/A
N=40
Effects of Obesity and Physical Inactivity on Pregnancy Outcomes
Obesity · Sedentary
Bottom Line
View on ClinicalTrials.gov: NCT02039414 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Neonatal Adiposity — 11.2; 12.4 % fat
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neonatal Adiposity |
11.2; 12.4 | — |
| PRIMARY Neonatal Insulin Resistance |
1.6; 1.9 | — |
| SECONDARY Maternal Inflammation |
9.1; 6.3 | — |
| SECONDARY Maternal Lipid Oxidation |
0.2150; 0.1950 | — |
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.
Eligibility 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: 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
- 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.
Data sourced from ClinicalTrials.gov (NCT02039414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.