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.

Design: A pilot Randomised-Controlled-Trial using different recruitment strategies.

Setting: A University Hospital in the United Kingdom.

Patients: Women seen at specialist gynaecology clinics over a 12 month period in one University Hospital, and women self identified through a website and posters.

Interventions: Potential recruits were assessed for eligibility, gave informed consent, randomised, treated and assessed as in the definitive trial.

Main outcome measures: 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.