title: Local recruitment experience in a study comparing the effectiveness of a low glycaemic index diet with a low calorie healthy eating approach at achieving weight loss and reducing the risk of endometrial cancer in women with polycystic ovary syndrome (PCOS).
abstract: OBJECTIVE
  Feasibility of a clinical-trial comparing a low-glycaemic diet with a low-calorie healthy eating approach at achieving weight loss and reducing the risk of endometrial cancer in women with PCOS.
  
  
  METHODS
  A pilot Randomised-Controlled-Trial using different recruitment strategies.
  
  
  METHODS
  A University Hospital in the United Kingdom.
  
  
  METHODS
  Women seen at specialist gynaecology clinics over a 12 month period in one University Hospital, and women self identified through a website and posters.
  
  
  METHODS
  Potential recruits were assessed for eligibility, gave informed consent, randomised, treated and assessed as in the definitive trial.
  
  
  METHODS
  Eligibility and recruitment rates, compliance with the allocated diet for 6 months and with clinical assessments, blood tests, pelvic ultrasound scans and endometrial biopsies.
  
  
  RESULTS
  1433 new and 2598 follow up patients were seen in 153 gynaecology clinics for over 12 months. 441 (11%) potentially eligible women were identified, 19 (0.4%) of whom met the trial entry criteria. Eleven consented to take part, of which 8 (73%) completed the study.
  
  
  CONCLUSIONS
  Planned future trials on over-weight women with PCOS should be multicentre and should incorporate primary care. This data will help other researchers plan and calculate the sample size and potential recruitment rates in future clinical trials in PCOS. The results will also be useful for inclusion in future meta-analyses.
authors.affiliation: Division of Human Development, School of Clinical Sciences, University of Nottingham, Nottingham, UK. William.atiomo@nottingham.ac.uk
authors.forename: William
authors.initials: W
authors.lastname: Atiomo
authors.forename: Anna
authors.initials: A
authors.lastname: Read
authors.forename: Mary
authors.initials: M
authors.lastname: Golding
authors.forename: Paul
authors.initials: P
authors.lastname: Silcocks
authors.forename: Nuguelis
authors.initials: N
authors.lastname: Razali
authors.forename: Sabitabrata
authors.initials: S
authors.lastname: Sarkar
authors.forename: Paul
authors.initials: P
authors.lastname: Hardiman
authors.forename: Jim
authors.initials: J
authors.lastname: Thornton
mesh_terms: D000328:Adult; D015992:Body Mass Index; D004038:Diet, Reducing; D016889:Endometrial Neoplasms / Q000453:epidemiology / Q000517:prevention & control*; D005240:Feasibility Studies; D005260:Female; D038321:Glycemic Index; D006801:Humans; D018579:Patient Selection; D011085:Polycystic Ovary Syndrome; D018570:Risk Assessment; D012307:Risk Factors; D006113:United Kingdom / Q000453:epidemiology; D015431:Weight Loss