title: Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial.
abstract: BACKGROUND
  Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity.
  
  
  METHODS
  We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2).
  
  
  RESULTS
  Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p < 0.001) and saturated fat intake (-1.6% energy, 95% CI -2.8 to -0. 3) at 28 weeks' gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery.
  
  
  CONCLUSIONS
  This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  ISRCTN89971375.
authors.forename: Lucilla
authors.initials: L
authors.lastname: Poston
authors.forename: Annette L
authors.initials: AL
authors.lastname: Briley
authors.forename: Suzanne
authors.initials: S
authors.lastname: Barr
authors.forename: Ruth
authors.initials: R
authors.lastname: Bell
authors.forename: Helen
authors.initials: H
authors.lastname: Croker
authors.forename: Kirstie
authors.initials: K
authors.lastname: Coxon
authors.forename: Holly N
authors.initials: HN
authors.lastname: Essex
authors.forename: Claire
authors.initials: C
authors.lastname: Hunt
authors.forename: Louise
authors.initials: L
authors.lastname: Hayes
authors.forename: Louise M
authors.initials: LM
authors.lastname: Howard
authors.forename: Nina
authors.initials: N
authors.lastname: Khazaezadeh
authors.forename: Tarja
authors.initials: T
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: Stephen C
authors.initials: SC
authors.lastname: Robson
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.forename: Thomas A B
authors.initials: TA
authors.lastname: Sanders
authors.forename: Jane
authors.initials: J
authors.lastname: Sandall
mesh_terms: D061725:Accelerometry; D000293:Adolescent; D000328:Adult; D001521:Behavior Therapy / Q000379:methods*; D015992:Body Mass Index; D016640:Diabetes, Gestational / Q000517:prevention & control*; D004035:Diet Therapy / Q000379:methods*; D005081:Exercise Therapy / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D009043:Motor Activity; D009765:Obesity / Q000628:therapy*; D010865:Pilot Projects; D011247:Pregnancy; D011248:Pregnancy Complications / Q000628:therapy*; D011295:Prenatal Care / Q000379:methods; D055815:Young Adult