UNITE-PCOS (v0.01)
Research type
Research Study
Full title
Understanding lifestyle behaviours in individuals with PCOS: a mixed-method investigation and measure development study (UNITE-PCOS)
IRAS ID
331378
Contact name
Chris Kite
Contact email
Sponsor organisation
The University of Wolverhampton
Clinicaltrials.gov Identifier
0923CKUOWHEA, Institutional Ethics Reference
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder, affecting 15-20% of reproductive-aged women. PCOS is typically diagnosed based on the presence of at least two out of three criteria: irregular periods, hyperandrogenism, and polycystic ovaries. People with PCOS also have increased risk of cardiometabolic (e.g., obesity, insulin resistance, and type 2 diabetes) and psychological health issues, which reduces quality of life (QoL). Typically, management of people with PCOS aims to ease symptoms, and improve QoL. Accordingly, treatment recommendations focus on lifestyle changes aiming to increase physical activity and improve dietary habits.
Lifestyle interventions reportedly improve many health-related outcomes in a range of general and patient populations; they have also been shown to effective to support improvements in the health and wellbeing of people with PCOS. Given the importance of lifestyle in PCOS, there is need for accurate measurement of lifestyle behaviours, so that its management can be appropriately identified and tailored. No such measurement tool exists for people with PCOS. We previously identified that such tools should be developed in conjunction with people with PCOS and should be more inclusive of everyone’s circumstances. Therefore, this project aims to co-design such a measure, specifically for people with PCOS. There will be three studies conducted as part of this project.1) People with PCOS will be recruited for interviews/focus groups to provide their experiences of lifestyle using an interview schedule based on their capability, opportunity, and motivation. This will determine the structure of a pilot questionnaire.
2) The second study will trial the questionnaire with people with PCOS and be subject to exploratory factor analysis. Validity will also be assessed by clinicians and patient representatives.
3) A finalised version will be trialled with a unique sample from the target population and then subjected to confirmatory factor analysis to confirm validity.
REC name
HSC REC B
REC reference
23/NI/0170
Date of REC Opinion
18 Dec 2023
REC opinion
Further Information Favourable Opinion