Polycystic ovary syndrome: disorders of other endocrine glands Nutritional, Metabolic, Endocrine
Conditions
Interventions
Following the principles of the Person-Based Approach, the research team has developed a behavioural and dietary intervention to support patients with PCOS to change their diet in primary care. This p
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients: 1. Aged >= 18-45 years inclusive 2. BMI> = 27kg/m2 (> = 30kg/m2 if white ethnicity) 3. A coded diagnosis of PCOS 4. Able to attend the GP practice for appointments 5. Willingness and ability to provide informed consent
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 01/09/2025: 1. Current or recent (< 3 months) use of oral contraceptives or hormone replacement therapy 2. Current or recent (< 3 months) use of any hormonal contraception, including the contraceptive implant, contraceptive injection, contraceptive patch, vaginal ring or hormonal IUS systems (Mirena or JadeS) 3. Premature ovarian failure 4. Postmenopausal and/ or premature menopause 5. Pregnant, breastfeeding, currently undergoing fertility treatment 6. Type 1 diabetes 7. Active treatment for cancer (with the exception of non-melanoma skin cancer) 8. Following a structured weight-loss programme (including the use of GLP1 receptor agonists currently or in the 3 months prior to study enrolment) 9. SGLT2 inhibitors started in the 3 months prior to study enrolment 10. Unwilling to consider dietary changes 11. Clinician feels participation is inappropriate due to other reasons (such as, but not limited to mental health, awaiting surgery) 12. Diagnosed with a known eating disorder for whom the programme could be unsafe or require extensive monitoring to ensure safety 13. Diagnosed with a myocardial infarction or stroke in the past three months, uncontrolled cardiac conduction abnormalities, e.g. long QT syndrome, maculopathy or proliferative retinopathy 14. People with a diagnosis of type 2 diabetes 15. People taking part in other research that would compromise either their participation in POST or the other research study/ies that they are participating in There will be no exceptions made to allow into the study people who do not fulfil all these criteria. Previous key exclusion criteria: 1. Current or recent (< 3 months) use of oral contraceptives or hormone replacement therapy 2. Current or recent (< 3 months) use of any hormonal contraception, including the contraceptive implant, contraceptive injection, contraceptive patch, vaginal ring or hormonal IUS systems (Mirena or JadeS) 3. Premature ovarian failure 4. Postmenopausal and/ or premature menopause 5. Pregnant, breastfeeding, currently undergoing fertility treatment 6. Heart attack or stroke within the last 3 months 7. Type 1 diabetes 8. Active treatment for cancer (with the exception of non-melanoma skin cancer) 9. Following a structured weight-loss programme 10. GLP1-agonists or SGLT2 inhibitors started in the 3 months prior to study enrolment 11. Currently using insulin injections 12. Unwilling to consider dietary changes 13. Clinician feels participation is inappropriate due to other reasons (such as, but not limited to mental health, awaiting surgery) 14. Diagnosed with a known eating disorder for whom the programme could be unsafe or require extensive monitoring to ensure safety 15. Diagnosed with a recent myocardial infarction or stroke in the past three months, uncontrolled cardiac conduction abnormalities e.g. long QT syndrome, maculopathy or proliferative retinopathy 16. People with a current diagnosis of type 2 diabetes 17. People taking part in other research that would compromise either their participation in POST or the other research study/ies that they are participating in. There will be no exceptions made to allow into the study people who do not fulfil all these criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following progression criteria will determine whether to progress to a full study; all will be measured at 6 months: 1. The proportion of patients who agree to start the dietary intervention, measured using data recording after intervention visit by the nurse delivering the intervention session 2. Fidelity of intervention delivery will be measured by assessing audio-recorded consultations against a checklist of essential elements 3. Availability of data at final follow-up will be measured from documentation of the final study visit and/or record of provision of relevant data 4. Ability to recruit primary care sites and patients within the recruitment period (6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be assessed at 6 months: Process Measures: 1. Percentage of eligible patients as a proportion of total practice population 2. Percentage of people who fulfil the recruitment criteria who accept the invitation to participate 3. Participant adherence to the protocol: including, change in dietary composition (low-carbohydrate, energy restricted - assessed using dietary recall questionnaires); participants’ self-reported concordance with the intervention; availability of data for outcome measures; attendance at follow up sessions; contamination of the control group (i.e., those who choose to follow the principles of the intervention (i.e. follow a low-carbohydrate diet), despite being allocated to the control group). This will be assessed using food frequency questionnaires to establish change in dietary composition (frequency of carbohydrate consumption, energy restriction) of control group participants. 4. Proportion of people diagnosed with type 2 diabetes at baseline and throughout the defined study period 5. Proportion of people who choose to receive the intervention face-to-face, remote (either video consultation or phone call) or a combination Effectiveness Measures: 1. The change in weight 2. Mean change in systolic and diastolic blood pressure 3. Change in medication usage 4. Mean change in HbA1c concentration 5. Change in lipid profile – total cholesterol, HDL, triglycerides, calculated non-HDL cholesterol, and total cholesterol:HDL ratio 6. Change in QRISK3 score or SMART score 7. Change in the risk score for type 2 diabetes 8. Change in fasting glucose, fasting insulin and HOMA-IR score 9. Change in modified Ferriman-Gallwey score 10. Change in free androgen index 11. Change across total score of the EQ_5D_5L Qol questionnaire 12. Change across WHO-5 score 13. Self-assessment of the number of menstrual periods within the past 3 months, and the impact on menstrual bleeds Qualitative Measures: | — |
Countries
England, United Kingdom
Contacts
Public ContactJadine Scragg
Outcome results
None listed