Know Cancer

forgot password

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

18 Years
50 Years
Open (Enrolling)
Polycystic Ovary Syndrome

Thank you

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

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.

Inclusion Criteria:

- Females aged between 18-50 years with the diagnosis of PCOS according to Rotterdam
Criteria 2003 who are Overweight: (WHO 2010)

- Body Mass Index ≥ 23 kg/m2 for Black and Minor Ethnicities

- Body Mass Index ≥ 25 kg/m2 for White Europeans

- If already on medical treatment for their PCOS, they should be on a stable regime for
at least 6 months prior to the recruitment.

Exclusion Criteria:

- Physical condition which limits full participation in the study

- Active psychotic illness or a significant illness which, in the view of the
investigators, would prevent full participation

- Inability to communicate in verbal and written English

- Steroid use

- Diabetes

- Pregnancy

- Involvement in other research studies with similar nature

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

we aim for a 2000 steps increase in Number of steps per day

Outcome Description:

It has been shown that 1 mmol/L drop in 2 hours glucose tolerance test following lifestyle intervention is significantly effective in diabetes prevention equal to 50% reduction in progression to T2DM. A previous similar intervention in people with IGR by our group in Leicester achieved a significant drop of 1.31 mmol/L (SD 2 mmol/L) in 2 hours glucose tolerance through an increase of 2000 steps per day in walking activity (SD 4000 steps/day).

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Melanie Jane Davies, Prof (MD)

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Leicester


United Kingdom: Research Ethics Committee

Study ID:

UNOLE 0209



Start Date:

September 2011

Completion Date:

December 2013

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic Ovary Syndrome
  • Lifestyle
  • Structured Education
  • Walking Activity
  • Exercise
  • Overweight
  • Impaired Glucose Regulation
  • Diabetes Prevention
  • Polycystic Ovary Syndrome