Exercise Training in Pregnancy. Good for the Mother - Good for the Child?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Weight gain during pregnancy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Exercise training
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
Intervention: Exercise (Behavioral)
Control
Usual care as provided by the health services in Norway. The investigators will not advice the women to be inactive
Outcomes
Primary Outcomes
Weight gain during pregnancy
Time Frame: From 14 weeks pregnancy to delivery
Measured in kg
Secondary Outcomes
- Offspring birth weight, length and head circumference(At delivery)
- Delivery complications(At delivery)
- Blood markers for cardiovascular disease(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Markers of inflammation and metabolism in cord blood(At delivery)
- Fasting glucose(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Glucose tolerance(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Quality of life(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Lumbopelvic pain(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Insulin resistance(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Body composition(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Sleep(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Diet(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Urin- and fecal incontinence(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Physical activity(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)