Clinical trial NCT04777461: Living With Polycystic Ovary Syndrome
Official title: Living With Polycystic Ovary Syndrome- Structured Education Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: University of Hull
Sponsor class: OTHER
Collaborators: name: British Dietetic Association
First posted: 2021-03-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This project aims to develop and pilot an evidence-based structured education program that can be run in groups to enable women with PCOS to make lifestyle changes, which will help them improve their PCOS and reduce the risk of future PCOS-related complications.

Detailed description: The first aim of this project is to develop an evidence-based structured education programme for women with PCOS. According to the Medical Research Council framework for complex interventions, robust patient-education programmes should have an evidence-based structured written curriculum, which is delivered by trained educators and is regularly assessed and audited. To meet these standards, the investigators first aim to develop a written curriculum for the structured education programme, written presentation material for the educational sessions and participants' handouts, but also material for training for the educators who will deliver the programme.

The philosophy of the programme is based on patient empowerment. The structured group education programme will be based on psychological theories of learning including the Leventhal's common-sense theory, the dual-process theory, and the social learning theory. Similar to previous successful programmes in diabetes education and based on the experience gained by conducting the education programme "Living with type 2 diabetes" in our centre, the programme will be designed as a six-hour of education programme with a formal and informed curriculum. It will be offered in two three-hour sessions of teaching for 8-12 PCOS women at a time. Attendees will be encouraged to be accompanied by a person of their choice.

Initial thoughts on the curriculum and the format of the written material have been already discussed within our clinical and research team (Dr Papageorgiou, Professor Sathyapalan, Mrs Baldwin consultant endocrinologists, general practitioners and dietitian specialists/educators delivering the "Living with Diabetes" education programme for patients with type 2 diabetes) based on their experience and views expressed to them by women with PCOS. As such, the areas that will be covered in the structured education programme include:

* Thoughts and feelings of the participants around PCOS
* Understanding PCOS pathophysiology: what happens in the body
* Understanding the risk factors (e.g., obesity) and health risks associated with PCOS
* Emotional wellbeing and PCOS
* Management of PCOS symptoms -how to take control:

  * Pharmacological options (i.e., hormonal contraceptives, anti-androgens, and insulin sensitisers)
  * Lifestyle changes (i.e., basics of energy balance, healthy eating based on Eat well Plate, mindful eating, physical activity recommendations, practical advice).
* Planning for the future (e.g., family planning, screening for long-term conditions).

Importantly, the investigators are also going to conduct a patients' survey to find out what women with PCOS expect to gain from an educational programme addressing several aspects of PCOS. The investigators will use the collected data to further refine the aspects of PCOS that will be included in the final curriculum of the programme.

Eligibility criteria: Inclusion Criteria:

1. Willingness and ability to provide signed informed consent before any study activity.
2. Women aged 18-50 years (inclusive), with a confirmed diagnosis of PCOS based on Rotterdam criteria.
3. Body mass index \> 25 kg/m²

Exclusion Criteria:

1. Participants under 18 years or over 50 years old.
2. Participants who cannot adequately understand verbal and written explanations given in English.
3. Lack of mental capacity to give written consent.

Primary outcomes:
measure: develop an evidence-based structured education programme for women with PCOS
timeFrame: 12 months
measure: Pilot the structured education programme
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism
Study officials:
References: