Clinical trial NCT01243554: Exercise Training in Pregnancy for Obese Mothers
Official title: Exercise Training in Pregnancy. Good for the Mother - Good for the Child?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Obesity
Keywords: Exercise training
Pregnancy
Obesity
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Norwegian School of Sport Sciences
name: Karolinska Institutet
name: St. Olavs Hospital
First posted: 2010-11-18
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight gain during pregnancy
timeFrame: From 14 weeks pregnancy to delivery
Secondary outcomes:
measure: Fasting glucose
timeFrame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
measure: Glucose tolerance
timeFrame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
measure: Insulin resistance
timeFrame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
measure: Body composition
timeFrame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
measure: Blood markers for cardiovascular disease
timeFrame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
measure: Lumbopelvic pain
timeFrame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
measure: Urin- and fecal incontinence
timeFrame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
measure: Quality of life
timeFrame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
measure: Sleep
timeFrame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
measure: Physical activity
timeFrame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
measure: Diet
timeFrame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
measure: Offspring birth weight, length and head circumference
timeFrame: At delivery
measure: Delivery complications
timeFrame: At delivery
measure: Markers of inflammation and metabolism in cord blood
timeFrame: At delivery
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Trine T Moholdt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garnaes KK, Morkved S, Salvesen O, 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.
citation: Garnaes KK, Nyrnes SA, Salvesen KA, Salvesen O, Morkved 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 trial. PLoS One. 2017 Mar 21;12(3):e0173937. doi: 10.1371/journal.pone.0173937. eCollection 2017.
citation: Garnaes KK, Morkved S, Salvesen KA, Salvesen O, 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 Childbirth. 2018 Jan 8;18(1):18. doi: 10.1186/s12884-017-1653-5.
citation: Nyrnes SA, Garnaes KK, Salvesen O, 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.0197334. eCollection 2018.
citation: Garnaes KK, Helvik AS, Stafne SN, Morkved S, Salvesen K, Salvesen O, 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 controlled trial. BMJ Open. 2019 Nov 21;9(11):e028252. doi: 10.1136/bmjopen-2018-028252.
citation: Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
citation: Ingul CB, Loras L, Tegnander E, Eik-Nes SH, Brantberg A. Maternal obesity affects fetal myocardial function as early as in the first trimester. Ultrasound Obstet Gynecol. 2016 Apr;47(4):433-42. doi: 10.1002/uog.14841. Epub 2016 Mar 14.
citation: Moholdt TT, Salvesen K, Ingul CB, Vik T, Oken E, Morkved S. Exercise Training in Pregnancy for obese women (ETIP): study protocol for a randomised controlled trial. Trials. 2011 Jun 17;12:154. doi: 10.1186/1745-6215-12-154.