Exercise Training in Pregnancy for Obese Mothers
- Conditions
- PregnancyObesity
- Interventions
- Behavioral: Exercise
- Registration Number
- NCT01243554
- Lead Sponsor
- Norwegian University of Science and Technology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 91
- Pre-pregnancy body mass index of 28 or more
- 18 years or more
- singleton live fetus at the routine ultrasound scan
- high risk for preterm labor or diseases that could interfere with participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise training Exercise Supervised exercise training at the hospital during pregnancy: the women will attend at least 2 weekly sessions consisting of aerobic exercise (walking on treadmills), strength training (for upper body, back, abdomen and legs) as well as pelvic floor muscle exercises. Each session is 60 minutes and lead by a physiotherapist or experienced exercise physiologist. The women will also go through motivational interviewing sessions throughout the intervention period and are encouraged to do home exercise training in addition to the exercise at the hospital
- Primary Outcome Measures
Name Time Method Weight gain during pregnancy From 14 weeks pregnancy to delivery Measured in kg
- Secondary Outcome Measures
Name Time Method Blood markers for cardiovascular disease 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.
Markers of inflammation and metabolism in cord blood At delivery Cord blood will be sampled and stored for later analysis of relevant markers of inflammation and metabolism (including resistin, leptin, adiponectin)
Fasting glucose 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)
Glucose tolerance 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.
Quality of life From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum Validated questionnaire
Lumbopelvic pain 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.
Insulin resistance From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum Homeostasis model assessment (HOMA-IR)
Body composition 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.
Sleep From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum Epworth sleepiness scale
Diet From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum Validated questionnaire: Norkost
Offspring birth weight, length and head circumference At delivery As recorded by the hospital
Delivery complications At delivery Vaginal or caesarean delivery, and recorded complications during the delivery
Urin- and fecal incontinence 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
Physical activity 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
Trial Locations
- Locations (1)
Norwegian University of Science and Technology
🇳🇴Trondheim, Norway