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Exercise Training in Pregnancy for Obese Mothers

Exercise Training in Pregnancy. Good for the Mother - Good for the Child?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01243554
Enrollment
91
Registered
2010-11-18
Start date
2010-09-30
Completion date
2016-06-30
Last updated
2020-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Pregnancy

Keywords

Exercise training, Pregnancy, Obesity

Brief summary

Observational studies demonstrate that overweight in pregnancy is a risk factor for adverse pregnancy outcomes as fetal macrosomia, prolonged labor, low Apgar score, shoulder dystocia, nerve plexus injuries, increased proportion of instrumental deliveries and perineal ruptures. There is a 2.6 fold risk for gestational diabetes mellitus (fourfold in morbidly obese women) and a recent study has shown that fetuses of obese mothers develop insulin resistance in uterus. Main aims of this study are to assess if regular exercise in pregnancy among obese women can prevent or influence weight gain; impaired cardiac function in mother and fetus/newborn; impaired vascular function in mother; insulin resistance/sensitivity; body composition in mother and offspring; lumbopelvic pain; urinary and/or fecal incontinence; prolonged labor

Detailed description

Women with a self-reported pre-pregnancy BMI of 28 or more will be eligible for our study. Woman are eligible if they are 18 years or older, with a singleton live fetus at an early (week 12-14) ultrasound scan. Exclusion criteria are pregnancy complications with high risk for preterm labour or diseases that could interfere with participation. Primary outcome measure is weight increase based on weight measured at 14 weeks and immediately before labour. Assessments are done at baseline at 14 (12-18) weeks of pregnancy, and again in week 38, as well as 3 months postpartum. Some measurements are also done at other points in time. The maternal secondary outcome measurements include fasting glucose, glucose tolerance assessed by 2-h, 75 mg per-oral glucose tolerance test, insulin resistance assessed by HOMA-IR, weight, height, body composition estimated by skinfold measurements in pregnancy and by dual energy x-ray absorptiometry postpartum, blood markers, lumbopelvic pain, urin- and fecal incontinence, quality of life, psychological wellbeing, depression, and diet.

Interventions

BEHAVIORALExercise

Exercise training at the hospital

Sponsors

Harvard Medical School (HMS and HSDM)
CollaboratorOTHER
Norwegian School of Sport Sciences
CollaboratorOTHER
Karolinska Institutet
CollaboratorOTHER
St. Olavs Hospital
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Pre-pregnancy body mass index of 28 or more * 18 years or more * singleton live fetus at the routine ultrasound scan

Exclusion criteria

* high risk for preterm labor or diseases that could interfere with participation

Design outcomes

Primary

MeasureTime frameDescription
Weight gain during pregnancyFrom 14 weeks pregnancy to deliveryMeasured in kg

Secondary

MeasureTime frameDescription
Fasting glucoseFrom 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartumBlood samples to determine the fasting glucose after an overnight fast (\>10 hours)
Glucose toleranceFrom 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum2 hour 75 mg per-oral glucose tolerance test. Gestational diabetes is diagnosed as fasting glucose = or \> 6.9 mmol/L or 2h concentration = or \> 7.8 mmol/L.
Body compositionFrom 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartumSkinfold measurements, done by an experienced investigator using Harpenden kaliper. At the 3 months postpartum testing, also dual energy x-ray absorptiometry (DEXA scan) will be used.
Blood markers for cardiovascular diseaseFrom 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartumInflammation markers, cytokines (leptin, resistin, adiponectin, tnf-alfa). Blood will be collected and stored for later analyses.
Lumbopelvic painFrom 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartumClinical assessment (active straight leg raising, pelvic provocation test), and validated questionnaire.
Urin- and fecal incontinenceFrom 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartumPelvic floor muscle function will be assessed by clinical assessment and by 2D and 3D ultrasound. The prevalence and severity of urin- and fecal incontinence will also be assessed by a validated questionnaire
Insulin resistanceFrom 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartumHomeostasis model assessment (HOMA-IR)
SleepFrom 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartumEpworth sleepiness scale
Physical activityFrom 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartumLevel of physical activity will be assessed by activity registration (armbands) and by validated questionnaires
DietFrom 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartumValidated questionnaire: Norkost
Offspring birth weight, length and head circumferenceAt deliveryAs recorded by the hospital
Delivery complicationsAt deliveryVaginal or caesarean delivery, and recorded complications during the delivery
Markers of inflammation and metabolism in cord bloodAt deliveryCord blood will be sampled and stored for later analysis of relevant markers of inflammation and metabolism (including resistin, leptin, adiponectin)
Quality of lifeFrom 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartumValidated questionnaire

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026