POST
Research type
Research Study
Full title
Polycystic ovary syndrome trial (POST): dietary approaches to the management of Polycystic Ovary Syndrome
IRAS ID
331409
Contact name
Jadine Scragg
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
Aim
To assess the feasibility to deliver this intervention (a low energy low carbohydrate food-based diet and support from practice nurses) in primary care (primary outcome) and evaluate its impact on weight change alongside clinical and symptomatic markers of PCOS (secondary).Background
Primary care records show that about 2% of women aged 15-45 years old have a coded diagnosis of Polycystic ovary syndrome (PCOS), but it is likely underdiagnosed. People with PCOS commonly experience symptoms such as anovulation, menstrual cycle irregularity and hyperandrogenism. However, variability in presenting symptoms, provider confidence, and patient education gaps contribute to delayed interventions, suboptimal patient care, and diminished quality of life.We developed this programme using “real food”, supporting patient self-management to reduce the demand on practitioner time so it is realistic for the NHS. We tested this in a feasibility trial for people with type 2 diabetes, showing we could recruit people with T2D who followed the programme with nurses delivering the programme as intended.
Design and methods
In this trial, we will recruit practices nationally, aiming to include 40 people from approximately 5-7 general practices who are socially representative of the UK population. We will ask practices to invite people with PCOS who are overweight and meet the study criteria. Interested persons will be able to contact the trial team for more details. If the person appears eligible after a brief phone screening, s/he will see a nurse at their GP who will confirm eligibility and take informed consent and then measure height, weight, blood pressure, and take a blood test.We will randomise participants in a 1:1 (intervention: control) ratio, stratifying by general practice. Participants offered the programme will be invited to see the nurse for six extra appointment over 6 months.
At 3 and 6 months (post-baseline visit), we will repeat the baseline measures for all participants.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0210
Date of REC Opinion
22 Jul 2025
REC opinion
Further Information Favourable Opinion