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PregnancyNCT01243554

Exercise Training in Pregnancy for Obese Mothers

A study testing Exercise in people with Pregnancy and Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy, Obesity
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteNorway
Study dates
Sep 2010to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Norwegian University of Science and Technology

    Trondheim, 7489

Other trials in Norway

About this study

Official title: 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

Read the 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.

Conditions
Pregnancy, Obesity
Being tested
Exercise
Keywords
Exercise training, Pregnancy, Obesity
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    Also called Training

    Exercise training at the hospital

Study groups in NCT01243554
Study groupRoleWhat they receive
Exercise trainingExperimentalSupervised 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
Receives: Behavioral: Exercise
ControlNo interventionUsual care as provided by the health services in Norway. The investigators will not advice the women to be inactive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight gain during pregnancy

    Measured in kg

    Measured: From 14 weeks pregnancy to delivery

Secondary outcomes (14)

  1. Fasting glucose

    Blood samples to determine the fasting glucose after an overnight fast (>10 hours)

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

  2. 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.

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

  3. Insulin resistance

    Homeostasis model assessment (HOMA-IR)

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

  4. 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.

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

  5. Blood markers for cardiovascular disease

    Inflammation markers, cytokines (leptin, resistin, adiponectin, tnf-alfa). Blood will be collected and stored for later analyses.

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

  6. Lumbopelvic pain

    Clinical assessment (active straight leg raising, pelvic provocation test), and validated questionnaire.

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

  7. 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

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

  8. Quality of life

    Validated questionnaire

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

  9. Sleep

    Epworth sleepiness scale

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

  10. Physical activity

    Level of physical activity will be assessed by activity registration (armbands) and by validated questionnaires

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

  11. Diet

    Validated questionnaire: Norkost

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

  12. Offspring birth weight, length and head circumference

    As recorded by the hospital

    Measured: At delivery

  13. Delivery complications

    Vaginal or caesarean delivery, and recorded complications during the delivery

    Measured: At delivery

  14. 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)

    Measured: At delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJun 2015
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01243554
Sponsor's protocol ID
ETiP-Ob
Status last verified
Jun 2018
First submitted
6 Sep 2010
Last updated
28 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27459375

  • 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.

    PubMed 28323893

  • 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.

    PubMed 29310617

  • 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.

    PubMed 29856768

  • 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.

    PubMed 31753866

  • 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.

    PubMed 39610995

  • 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.

    PubMed 32378735

  • 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.

    PubMed 25761057

  • 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.

    PubMed 21682869

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Pregnancy and Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight gain during pregnancy (time frame: From 14 weeks pregnancy to delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01243554, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.

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