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.
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There was no difference between the diet-delivery methods for most anthropometric, QoL, and emotional wellbeing outcomes.
“There was no difference between the diet-delivery methods for most anthropometric, QoL, and emotional wellbeing outcomes.”
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- Authors
- Atiomo, W., Read, A., Golding, M., Silcocks, P., Razali, N., Sarkar, S., Hardiman, P., & Thornton, J.
- Affiliations
- University of Nottingham (GB)
- Nottingham University Hospitals NHS Trust (GB)
- University of Malaya (MY)
- Royal Derby Hospital (GB)
- The Royal Free Hospital (GB)
- Corresponding author
- Atiomo, William
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2009-09
- Volume
- 30
- Issue
- 5
- Pages
- 451-456
- ISSN
- 1551-7144 (ISSN-L)
- OpenAlex
- W2064496465
- Cited by
- 28
- References
- 13
- Citations by year
- 2025: 5 · 2024: 3 · 2023: 1 · 2021: 3 · 2020: 2 · 2019: 2 · 2017: 1 · 2015: 2 · 2014: 3 · 2013: 1 · 2012: 2
- FWCI
- 1.96
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Contemporary Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- Cancer Research UK (C20654/A7380)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Health Professions › Health Information Management › Methodologies in Health Research and Practice
- Keywords
- polycystic ovary syndrome, trial recruitment, local recruitment, low glycemic index diet, hypocaloric diet, weight loss, endometrial cancer risk, trial feasibility, overweight women, dietary adherence
- MeSH terms
- Adult, Diet, Reducing, Feasibility Studies, Female, United Kingdom, Humans, Polycystic Ovary Syndrome, Risk Factors, Weight Loss, Body Mass Index, Endometrial Neoplasms, Risk Assessment, Patient Selection, Glycemic Index
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