Skip to main content
OpenTrials
Completed

NCT Number: NCT01243554

Exercise Training in Pregnancy for Obese Mothers

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian University of Science and Technology

Trondheim, 7489, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Exercise training at the hospital

Other names: Training

Primary outcomes

  1. Weight gain during pregnancy

    Time frame: From 14 weeks pregnancy to delivery

    Measured in kg

Secondary outcomes

  1. Fasting glucose

    Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum

    Blood samples to determine the fasting glucose after an overnight fast (>10 hours)

  2. Glucose tolerance

    Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum

    2 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.

  3. Insulin resistance

    Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum

    Homeostasis model assessment (HOMA-IR)

  4. Body composition

    Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum

    Skinfold 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.

  5. Blood markers for cardiovascular disease

    Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum

    Inflammation markers, cytokines (leptin, resistin, adiponectin, tnf-alfa). Blood will be collected and stored for later analyses.

  6. Lumbopelvic pain

    Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum

    Clinical assessment (active straight leg raising, pelvic provocation test), and validated questionnaire.

  7. Urin- and fecal incontinence

    Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum

    Pelvic 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

  8. Quality of life

    Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum

    Validated questionnaire

  9. Sleep

    Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum

    Epworth sleepiness scale

  10. Physical activity

    Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum

    Level of physical activity will be assessed by activity registration (armbands) and by validated questionnaires

  11. Diet

    Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum

    Validated questionnaire: Norkost

  12. Offspring birth weight, length and head circumference

    Time frame: At delivery

    As recorded by the hospital

  13. Delivery complications

    Time frame: At delivery

    Vaginal or caesarean delivery, and recorded complications during the delivery

  14. Markers of inflammation and metabolism in cord blood

    Time frame: At delivery

    Cord blood will be sampled and stored for later analysis of relevant markers of inflammation and metabolism (including resistin, leptin, adiponectin)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • Karolinska Institutet
  • Norwegian School of Sport Sciences
  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Nov 18, 2010
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.