Exercise Training in Pregnancy for Obese Mothers

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Pregnancy
• Intervention / Treatment: Behavioral: Exercise

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 Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7489
    • Norwegian University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Exercise; Exercise training at the hospital; Other Names: Training
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Harvard Medical School (HMS and HSDM); Karolinska Institutet; St. Olavs Hospital; Norwegian School of Sport Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 6, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 18, 2010

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Pregnancy; Exercise training
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: ETiP-Ob

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No