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Trial Outcomes & Findings for Effects of Obesity and Physical Inactivity on Pregnancy Outcomes (NCT NCT02039414)

NCT ID: NCT02039414

Last Updated: 2016-08-22

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

40 participants

Primary outcome timeframe

24-48 hr after delivery

Results posted on

2016-08-22

Participant Flow

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
22
18
Overall Study
COMPLETED
16
16
Overall Study
NOT COMPLETED
6
2

Reasons for withdrawal

Reasons for withdrawal
Measure
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
Overall Study
Delivered
1
1
Overall Study
Lost to Follow-up
2
0
Overall Study
Protocol Violation
3
1

Baseline Characteristics

Effects of Obesity and Physical Inactivity on Pregnancy Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Obese, Inactive
n=22 Participants
Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
Obese, Active
n=18 Participants
Pregnant women with a BMI≥30kg/m2 and exercising \>150min/week
Total
n=40 Participants
Total of all reporting groups
Age, Continuous
25.0 Years
STANDARD_DEVIATION 4.8 • n=5 Participants
28.9 Years
STANDARD_DEVIATION 4.8 • n=7 Participants
26.95 Years
STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
18 Participants
n=7 Participants
40 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
13 Participants
n=5 Participants
8 Participants
n=7 Participants
21 Participants
n=5 Participants
Race (NIH/OMB)
White
8 Participants
n=5 Participants
9 Participants
n=7 Participants
17 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Nulliparous
12 participants
n=5 Participants
9 participants
n=7 Participants
21 participants
n=5 Participants
Low Income
10 participants
n=5 Participants
5 participants
n=7 Participants
15 participants
n=5 Participants

PRIMARY outcome

Timeframe: 24-48 hr after delivery

Population: Several babies were not able to be measured for this part of the study- the primary reason being a weekend delivery that was discharged before measurements could be obtained by the study team. Our clinical research unit was not open on weekends to the the Peapod scans. This explains why there were only 15 babies per group for this outcome.

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.

Outcome measures

Outcome measures
Measure
Obese, Inactive
n=15 Participants
Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
Obese, Active
n=15 Participants
Pregnant women with a BMI≥30kg/m2 and exercising \>150min/week
Neonatal Adiposity
11.2 % fat
Standard Deviation 3.6
12.4 % fat
Standard Deviation 2.9

PRIMARY outcome

Timeframe: Immediately after delivery

Population: We could not obtain cord blood on all infants (thus, specimens were obtained fro 14 obese active and 12 obese inactive women). Due to medical emergencies or lack-of cord blood available, there were several instances where these specimens could not be obtained by the study team.

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.

Outcome measures

Outcome measures
Measure
Obese, Inactive
n=14 Participants
Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
Obese, Active
n=12 Participants
Pregnant women with a BMI≥30kg/m2 and exercising \>150min/week
Neonatal Insulin Resistance
1.6 HOMA_IR, unitless measure
Standard Deviation 1.2
1.9 HOMA_IR, unitless measure
Standard Deviation 1.6

SECONDARY outcome

Timeframe: 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).

Population: Of the 40 women consented, only 32 (16 in each group, completed the study visits). Thus, these 32 have CRP data.

High-Sensitivity C-reactive protein was measured.

Outcome measures

Outcome measures
Measure
Obese, Inactive
n=16 Participants
Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
Obese, Active
n=16 Participants
Pregnant women with a BMI≥30kg/m2 and exercising \>150min/week
Maternal Inflammation
9.1 mg/L
Standard Deviation 4.0
6.3 mg/L
Standard Deviation 2.5

SECONDARY outcome

Timeframe: 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).

Population: Of the 40 women consented, only 32 (16 per group) completed all study visits and have lipid oxidation data.

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 .

Outcome measures

Outcome measures
Measure
Obese, Inactive
n=16 Participants
Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
Obese, Active
n=16 Participants
Pregnant women with a BMI≥30kg/m2 and exercising \>150min/week
Maternal Lipid Oxidation
0.2150 g/min
Standard Deviation 0.0864
0.1950 g/min
Standard Deviation 0.0790

Adverse Events

Obese, Inactive

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Obese, Active

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rachel Tinius, Assistant Professor

Western Kentucky University

Phone: 2707455026

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place