Exercise Training in Pregnancy for Obese Mothers

NCT01243554 | Completed

• 1 other identifier: ETiP-Ob
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy; Obesity

Keywords

Exercise training; Pregnancy; Obesity

Outcome Measures

Primary Outcomes (1)

• Weight gain during pregnancy

  Measured in kg

  From 14 weeks pregnancy to delivery

Secondary Outcomes (14)

• 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

• 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

• Blood markers for cardiovascular disease

  From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum

Study Arms (2)

Exercise training

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual care as provided by the health services in Norway. The investigators will not advice the women to be inactive

Interventions

Exercise BEHAVIORAL

Exercise training at the hospital

Also known as: Training

Exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-pregnancy body mass index of 28 or more
• years or more
• singleton live fetus at the routine ultrasound scan

You may not qualify if:

• high risk for preterm labor or diseases that could interfere with participation

Sponsors & Collaborators

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

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7489, Norway

Location

Related Publications (9)

• 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.

  PMID: 27459375 RESULT

• 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.

  PMID: 28323893 RESULT

• 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.

  PMID: 29310617 RESULT

• 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.

  PMID: 29856768 RESULT

• 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.

  PMID: 31753866 RESULT

• Moholdt T, Garnaes KK, Vik IP, Morkved S, Salvesen KA, Ingul CB. Cardiovascular effects of exercise training in pregnant people with a high body mass index: secondary results from a randomised controlled trial (ETIP). BMJ Open Sport Exerc Med. 2024 Nov 21;10(4):e002099. doi: 10.1136/bmjsem-2024-002099. eCollection 2024.

  PMID: 39610995 DERIVED

• 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.

  PMID: 32378735 DERIVED

• 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.

  PMID: 25761057 DERIVED

• 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.

  PMID: 21682869 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Trine T Moholdt, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2010
• First Posted: November 18, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: January 28, 2020

Record last verified: 2018-06

Locations

NO (1)