Exercise Training in Pregnancy for Obese Mothers
24 gennaio 2020 aggiornato da: Norwegian University of Science and Technology
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
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
91
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Trondheim, Norvegia, 7489
- Norwegian University of Science and Technology
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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
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Exercise training at the hospital
Altri nomi:
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Nessun intervento: Control
Usual care as provided by the health services in Norway.
The investigators will not advice the women to be inactive
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Weight gain during pregnancy
Lasso di tempo: From 14 weeks pregnancy to delivery
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Measured in kg
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From 14 weeks pregnancy to delivery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Fasting glucose
Lasso di tempo: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Blood samples to determine the fasting glucose after an overnight fast (>10 hours)
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From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Glucose tolerance
Lasso di tempo: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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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.
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From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Insulin resistance
Lasso di tempo: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Homeostasis model assessment (HOMA-IR)
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From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Body composition
Lasso di tempo: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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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.
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From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Blood markers for cardiovascular disease
Lasso di tempo: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Inflammation markers, cytokines (leptin, resistin, adiponectin, tnf-alfa).
Blood will be collected and stored for later analyses.
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From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Lumbopelvic pain
Lasso di tempo: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Clinical assessment (active straight leg raising, pelvic provocation test), and validated questionnaire.
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From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Urin- and fecal incontinence
Lasso di tempo: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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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
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From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Quality of life
Lasso di tempo: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Validated questionnaire
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From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Sleep
Lasso di tempo: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Epworth sleepiness scale
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From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Physical activity
Lasso di tempo: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Level of physical activity will be assessed by activity registration (armbands) and by validated questionnaires
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From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Diet
Lasso di tempo: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Validated questionnaire: Norkost
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From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
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Offspring birth weight, length and head circumference
Lasso di tempo: At delivery
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As recorded by the hospital
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At delivery
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Delivery complications
Lasso di tempo: At delivery
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Vaginal or caesarean delivery, and recorded complications during the delivery
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At delivery
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Markers of inflammation and metabolism in cord blood
Lasso di tempo: At delivery
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Cord blood will be sampled and stored for later analysis of relevant markers of inflammation and metabolism (including resistin, leptin, adiponectin)
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At delivery
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2010
Completamento primario (Effettivo)
1 giugno 2015
Completamento dello studio (Effettivo)
1 giugno 2016
Date di iscrizione allo studio
Primo inviato
6 settembre 2010
Primo inviato che soddisfa i criteri di controllo qualità
17 novembre 2010
Primo Inserito (Stima)
18 novembre 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
28 gennaio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 gennaio 2020
Ultimo verificato
1 giugno 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ETiP-Ob
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .