Exercise Training in Pregnancy for Obese Mothers

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243554
• Other study ID #: ETiP-Ob
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: June 2016

Study information

• Verified date: June 2018
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pregnancy

Intervention

Behavioral:
• Exercise
Exercise training at the hospital

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Harvard Medical School, Karolinska Institutet, Norwegian School of Sport Sciences, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Garnæs KK, Helvik AS, Stafne SN, Mørkved S, Salvesen K, Salvesen Ø, Moholdt T. Effects of supervised exercise training during pregnancy on psychological well-being among overweight and obese women: secondary analyses of the ETIP-trial, a randomised contro — View Citation

Garnæs KK, Mørkved S, Salvesen KÅ, Salvesen Ø, Moholdt T. Exercise training during pregnancy reduces circulating insulin levels in overweight/obese women postpartum: secondary analysis of a randomised controlled trial (the ETIP trial). BMC Pregnancy Child — View Citation

Garnæs KK, Mørkved S, Salvesen Ø, Moholdt T. Exercise Training and Weight Gain in Obese Pregnant Women: A Randomized Controlled Trial (ETIP Trial). PLoS Med. 2016 Jul 26;13(7):e1002079. doi: 10.1371/journal.pmed.1002079. eCollection 2016 Jul. — View Citation

Garnæs KK, Nyrnes SA, Salvesen KÅ, Salvesen Ø, Mørkved S, Moholdt T. Effect of supervised exercise training during pregnancy on neonatal and maternal outcomes among overweight and obese women. Secondary analyses of the ETIP trial: A randomised controlled — View Citation

Nyrnes SA, Garnæs KK, Salvesen Ø, Timilsina AS, Moholdt T, Ingul CB. Cardiac function in newborns of obese women and the effect of exercise during pregnancy. A randomized controlled trial. PLoS One. 2018 Jun 1;13(6):e0197334. doi: 10.1371/journal.pone.019 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain during pregnancy	Measured in kg	From 14 weeks pregnancy to delivery
Secondary	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
Secondary	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
Secondary	Insulin resistance	Homeostasis model assessment (HOMA-IR)	From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of life	Validated questionnaire	From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary	Sleep	Epworth sleepiness scale	From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary	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
Secondary	Diet	Validated questionnaire: Norkost	From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary	Offspring birth weight, length and head circumference	As recorded by the hospital	At delivery
Secondary	Delivery complications	Vaginal or caesarean delivery, and recorded complications during the delivery	At delivery
Secondary	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