title: A complex intervention to improve pregnancy outcome in obese women; the UPBEAT randomised controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current controlled trials; ISRCTN89971375.
authors.forename: Annette L
authors.initials: AL
authors.lastname: Briley
authors.forename: Suzanne
authors.initials: S
authors.lastname: Barr
authors.forename: Shirlene
authors.initials: S
authors.lastname: Badger
authors.forename: Ruth
authors.initials: R
authors.lastname: Bell
authors.forename: Helen
authors.initials: H
authors.lastname: Croker
authors.forename: Keith M
authors.initials: KM
authors.lastname: Godfrey
authors.forename: Bridget
authors.initials: B
authors.lastname: Holmes
authors.forename: Tarja I
authors.initials: TI
authors.lastname: Kinnunen
authors.forename: Scott M
authors.initials: SM
authors.lastname: Nelson
authors.forename: Eugene
authors.initials: E
authors.lastname: Oteng-Ntim
authors.forename: Nashita
authors.initials: N
authors.lastname: Patel
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Robson
authors.forename: Jane
authors.initials: J
authors.lastname: Sandall
authors.forename: Thomas
authors.initials: T
authors.lastname: Sanders
authors.forename: Naveed
authors.initials: N
authors.lastname: Sattar
authors.forename: Paul T
authors.initials: PT
authors.lastname: Seed
authors.forename: Jane
authors.initials: J
authors.lastname: Wardle
authors.affiliation: Division of Women's Health, Women's Health Academic Centre, King's College London and King's Health Partners, 10th floor, North Wing, St,Thomas' Hospital, London SE1 7EH, UK. lucilla.poston@kcl.ac.uk.
authors.forename: Lucilla
authors.initials: L
authors.lastname: Poston
mesh_terms: D000328:Adult; D001521:Behavior Therapy / Q000379:methods*; D001786:Blood Glucose / Q000378:metabolism; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D038321:Glycemic Index; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D008019:Life Style; D009043:Motor Activity; D009765:Obesity / Q000097:blood / Q000453:epidemiology / Q000628:therapy*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000453:epidemiology / Q000517:prevention & control*; D011256:Pregnancy Outcome; D011295:Prenatal Care / Q000379:methods*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D001786:Blood Glucose