Exercise Training in Pregnancy for Obese Mothers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy, Obesity

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training<br>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 | Behavioral: Exercise<br>* Exercise training at the hospital<br>* Other names: Training;|
| No Intervention: Control<br>Usual care as provided by the health services in Norway. The investigators will not advice the women to be inactive | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain during pregnancy | Measured in kg | From 14 weeks pregnancy to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose | Blood samples to determine the fasting glucose after an overnight fast (>10 hours) | From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum | 
| Glucose tolerance | 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. | From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum | 
| Insulin resistance | Homeostasis model assessment (HOMA-IR) | From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum | 
| Body composition | 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. | From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum | 
| Blood markers for cardiovascular disease | Inflammation markers, cytokines (leptin, resistin, adiponectin, tnf-alfa). Blood will be collected and stored for later analyses. | From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum | 
| Lumbopelvic pain | Clinical assessment (active straight leg raising, pelvic provocation test), and validated questionnaire. | From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum | 
| Urin- and fecal incontinence | 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 | From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum | 
| Quality of life | Validated questionnaire | From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum | 
| Sleep | Epworth sleepiness scale | From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum | 
| Physical activity | Level of physical activity will be assessed by activity registration (armbands) and by validated questionnaires | From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum | 
| Diet | Validated questionnaire: Norkost | From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum | 
| Offspring birth weight, length and head circumference | As recorded by the hospital | At delivery | 
| Delivery complications | Vaginal or caesarean delivery, and recorded complications during the delivery | At delivery | 
| Markers of inflammation and metabolism in cord blood | Cord blood will be sampled and stored for later analysis of relevant markers of inflammation and metabolism (including resistin, leptin, adiponectin) | At delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise training, Pregnancy, Obesity