Exercise Training in Pregnancy for Obese Mothers
24. ledna 2020 aktualizováno: 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
Přehled studie
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
91
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Trondheim, Norsko, 7489
- Norwegian University of Science and Technology
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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
Ostatní jména:
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Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Weight gain during pregnancy
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Fasting glucose
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: At delivery
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As recorded by the hospital
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At delivery
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Delivery complications
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. září 2010
Primární dokončení (Aktuální)
1. června 2015
Dokončení studie (Aktuální)
1. června 2016
Termíny zápisu do studia
První předloženo
6. září 2010
První předloženo, které splnilo kritéria kontroly kvality
17. listopadu 2010
První zveřejněno (Odhad)
18. listopadu 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
28. ledna 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. ledna 2020
Naposledy ověřeno
1. června 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ETiP-Ob
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Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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