Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome

Summary

Polycystic Ovary syndrome (PCOS) is a common hormonal imbalance affecting about 12% of women in the UK. The number of women with PCOS is rising. They suffer from a combination of symptoms including excess hair, irregular/absent periods, and infertility. About 70% of women with PCOS are obese or overweight, 10% develop type 2 diabetes (T2DM), and 30-40% have some degrees of abnormality in controlling (metabolising) blood sugar. Studies have shown that if women with PCOS make change to their lifestyle (diet and activity), they may reduce their risk of getting diabetes and heart disease in the future. This study aims to develop and test a programme that can be run in groups (structured education), to support women with PCOS make the lifestyle changes needed to improve their PCOS and prevent future associated health problems. Structured education programmes are suitable for use within the NHS and are already recommended for individuals with T2DM, but have not been tested as a method of treatment for PCOS which is a high risk condition for T2DM.

The investigators aim to initially develop a specific education programme for women with PCOS using their expertise in their disease and defining their needs. The next step is to test this programme on 160 women with PCOS who will be selected from the investigators database or clinics. They will be divided randomly to two groups to receive either this programme or routine care.

The investigators will give them an accelerometer (a very small portable device). This will measure their physical activity and counts their daily steps. The investigators aim is to increase their step count by at least 2000 steps per day after one year.

The investigators believe that the group given the structured education will show some evidence of improvement in their glucose metabolism, and consequently decreased chance of developing diabetes.

Conditions

• Polycystic Ovary Syndrome

Interventions

BEHAVIORAL

Structured Lifestyle Education

A 3-4 hours group education delivered in a patient group composed of 4-8 patients and delivered by two healthcare professionals.

Sponsors & Collaborators

• Society for Endocrinology

  collaborator OTHER

• University of Leicester

  lead OTHER

Principal Investigators

• Melanie J Davies, Prof (MD) · University of Leicester

• Kamlesh Khunti, Prof (PhD) · University of Leicester

• Hamidreza Mani, MD · University of Leicester

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2014-12-31

Completion

2014-12-31

Countries

• United Kingdom

Study Locations