A complex intervention to improve pregnancy outcome in obese women; the UPBEAT randomised controlled trial.
A complex intervention to improve pregnancy outcome in obese women; the UPBEAT randomised controlled trial.
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DOI:
10.1186/1471-2393-14-74
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发表时间:
2014-02-18
影响因子:
3.1
通讯作者:
Poston L
中科院分区:
文献类型:
--
作者:
Briley AL;Barr S;Badger S;Bell R;Croker H;Godfrey KM;Holmes B;Kinnunen TI;Nelson SM;Oteng-Ntim E;Patel N;Robson SC;Sandall J;Sanders T;Sattar N;Seed PT;Wardle J;Poston L
Despite the widespread recognition that obesity in pregnant women is associated with adverse outcomes for mother and child, there is no intervention proven to reduce the risk of these complications. The primary aim of this randomised controlled trial is to assess in obese pregnant women, whether a complex behavioural intervention, based on changing diet (to foods with a lower glycemic index) and physical activity, will reduce the risk of gestational diabetes (GDM) and delivery of a large for gestational age (LGA) infant. A secondary aim is to determine whether the intervention lowers the long term risk of obesity in the offspring. Multicentre randomised controlled trial comparing a behavioural intervention designed to improve glycemic control with standard antenatal care in obese pregnant women. Inclusion criteria; women with a BMI ≥30 kg/m2 and a singleton pregnancy between 15+0 weeks and 18+6 weeks’ gestation. Exclusion criteria; pre-defined, pre-existing diseases and multiple pregnancy. Randomisation is on-line by a computer generated programme and is minimised by BMI category, maternal age, ethnicity, parity and centre. Intervention; this is delivered by a health trainer over 8 sessions. Based on control theory, with elements of social cognitive theory, the intervention is designed to improve maternal glycemic control. Women randomised to the control arm receive standard antenatal care until delivery according to local guidelines. All women have a 75 g oral glucose tolerance test at 27+0- 28+6 weeks’ gestation. Primary outcome; Maternal: diagnosis of GDM, according to the International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria. Neonatal; infant LGA defined as >90th customised birth weight centile. Sample size; 1546 women to provide 80% power to detect a 25% reduction in the incidence of GDM and a 30% reduction in infants large for gestational age. All aspects of this protocol have been evaluated in a pilot randomised controlled trial, with subsequent optimisation of the intervention. The findings of this trial will inform whether lifestyle mediated improvement of glycemic control in obese pregnant women can minimise the risk of pregnancy complications. Current controlled trials; ISRCTN89971375.
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影响因子:
16.2
作者:
Lowe LP;Metzger BE;Dyer AR;Lowe J;McCance DR;Lappin TR;Trimble ER;Coustan DR;Hadden DR;Hod M;Oats JJ;Persson B;HAPO Study Cooperative Research Group
通讯作者:
HAPO Study Cooperative Research Group
影响因子:
9.8
作者:
Ehrenberg, HM;Durnwald, CP;Mercer, BM
通讯作者:
Mercer, BM
影响因子:
16.2
作者:
Harmon KA;Gerard L;Jensen DR;Kealey EH;Hernandez TL;Reece MS;Barbour LA;Bessesen DH
通讯作者:
Bessesen DH
影响因子:
8.9
作者:
Heslehurst, N.;Simpson, H.;Summerbell, C. D.
通讯作者:
Summerbell, C. D.
影响因子:
8.9
作者:
Gardner, B.;Wardle, J.;Croker, H.
通讯作者:
Croker, H.