NCT03875300Fut, nem toboroz
Best Start - Weight Management During Pregnancy
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. aug. 22.
Rövid összefoglaló (regiszter, angolul)
The investigators know that being overweight during pregnancy increases the health risks to both mum and baby. There is good evidence that diet or exercise, or both, during pregnancy can reduce excessive weight gain. The Best Start study aims to test the theory that obese pregnant women with a Body Mass Index (BMI) of 30 or over who participate in a structured programme of nutrition and lifestyle advice (Foodwise in Pregnancy ™) will achieve the recommended weight gain during pregnancy of no less than 5kg and no more than 9.1kg. The investigators would like to find out if pregnant women with a BMI of 30 or over who receive the Best Start intervention are more likely to effectively manage weight gain during pregnancy. To achieve this, the investigators will undertake a trial that randomly puts participants into an experimental group, or a control group, which will compare those who receive the intervention to those who continue with routine antenatal care. The investigators are aiming to recruit around 500 women during the study period. 250 will receive the Best Start intervention, and 250 will continue with routine antenatal care. The investigators would also like to find out if women who gain the recommended weight during pregnancy have better outcomes, compared to women who gain more or less weight. To do this the investigators will look at the routine information collected during antenatal and postnatal care, for both mum and baby. To do this regardless of the group clients are randomised to, the investigators will ask for permission to look at the routine information within the participants maternity record. This information includes, weight gained during pregnancy, whether the baby is born early, the type of labour and delivery, and any complications during the pregnancy or delivery that may have resulted in the need for additional care for mum or baby. The results of the study will be prepared for publication in scientific journals, and for presentation at scientific conferences. All participants will be able to obtain a copy of the results once they have been published and any information that could identify participants will be removed.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 526 (tényleges)
- Első benyújtás
- 2019. jan. 28.
- Kezdés
- 2017. júl. 1.
- Elsődleges befejezés
- 2018. szept. 7.
- Fő szponzor
- Cwm Taf University Health Board (NHS)
- Betegségek
- Elhízás
- NCT-szám
- NCT03875300
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 526
- 2017. júl. 1. és az elsődleges befejezés (2018. szept. 7.) között
- 4 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- Any women who have pre-existing diabetes, or develop gestational diabetes during their pregnancy.
- Any health condition that means the health professional looking after the patient feels would contra-indicate involvement in this programme (e.g. losing the ability to consent during the programme)
Életkor
- Aged under 16.
Egyéb
- Pregnant women who at their early pregnancy dating scan (optimum time 12 weeks gestation, but with a tolerance of up to 16 full weeks gestation for women who book late) have a BMI of less than 29.9 and reside in Cwm Taf University Health Board area.
- Incapable of giving informed consent.
Kiket keres a vizsgálat
- Pregnant women who at their early pregnancy dating scan (optimum time 12 weeks gestation, but with a tolerance of up to 16 full weeks gestation for women who book late) have a BMI of 30 or over and reside in Cwm Taf University Health Board area.
- Aged over 16.
- Capable of giving informed consent.
- Singleton and multiple pregnancies.
Életkor a regiszterben: 16 év – - · Nem: csak nők · Egészséges önkénteseket is fogad
Helyszínek (4)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Royal Glamorgan Hospital | Llantrisant | Egyesült Királyság | Ismeretlen állapot |
| Prince Charles Hospital | Merthyr Tydfil | Egyesült Királyság | Ismeretlen állapot |
| Ysbyty Cwm Cynon Hospital | Mountain Ash | Egyesült Királyság | Ismeretlen állapot |
| Ysbyty Cwm Rhondda Hospital | Tonypandy | Egyesült Királyság | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.