CompletedNot Applicable

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

United Kingdom162 participantsStarted 2011-09

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: One year

Trial details

NCT IDNCT01462864

SponsorUniversity of Leicester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12