Trial Information

StructUred eduCation Programme to Improve Cardiovascular Risk in womEn With polycyStic Ovary Syndrome; SUCCESS Study

Overview of project plan:

Development of the structured education course: Year 1 (Phases 1&2)

Phase 1:

The SUCCESS intervention (structured education programme to improve cardiovascular risk in
women with PCOS) will be developed and piloted in line with the Medical Research Council's
framework for complex interventions. This will involve recruiting participants for focus
groups and interviews to allow the research group to develop a detailed understanding of
what the requirements of the structured education course are.

Inclusion criteria for patients in this phase is women with a clear diagnosis of PCOS based
on Rotterdam 2003 Criteria or National Institute of Health 1992 And 18< age <70 years
Participants will be recruited from a database of patients in our speciality clinic and also
primary care if needed and the interviews/ focus groups will be held in locations close to
the participant, or over the telephone.

Analysis of these sessions will provide invaluable data for the development of the
structured education course.

As part of this phase of the study we will perform a systematic review of the literature on
the previous lifestyle interventions in the PCOS.

We will also perform a demographic analysis of almost 2400 patients with diagnosis of PCOS
in University Hospitals of Leicester database. We already have the ethical approval for the
conducting routine database linkage studies including a linkage with the hospital admission
database in local Health Informatics Service. Demographic distribution of diagnosis,
complications of PCOS, cardiovascular outcomes, and reported comorbidities besides other
information such as deprivation score will inform us of the important issues need to be
considered in development of an education intervention for women with PCOS in phase 2 and 3.

Phase 2

Once the course has been designed, it will be piloted in one or two groups of women with
PCOS to get feedback on the content and delivery. These feedbacks will be incorporated in
the course and contents will be refreshed and refined.

For the above mentioned pilot sessions, patients will only attend a 3.5 hours education
session and no test or measurement will be done.

After each session their views on the content and delivery of the education will be sought.
We will continue to run these pilot sessions until we get no further new comments. Previous
experience with other similar interventions has shown that two pilot sessions are enough.

When the education programme is ready we can test its efficacy in a randomised controlled
trial.

Phase 3; Randomised controlled trial: Years 2 & 3

The primary hypothesis of the randomised controlled trial is:

"Structured education can increase physical activity measured as walking steps in women with
polycystic ovary syndrome."

Study design:

This is a randomised controlled community based trial. Participants will be randomised to
either the intervention or control group at the beginning. A controlled design for the
current study is essential given that it is unknown whether structured education is
effective at initiating a lifestyle change and whether it translates into improvements in
important markers of metabolic and vascular health. Therefore in order to inform health
policy evidence is needed from high quality randomized controlled trials carried out in a
community setting.

Our study intervention will not interfere with the routine care of a woman diagnosed with
PCOS, whether the patient is recruited from speciality clinics or in primary care.