StructUred eduCation Programme to Improve Cardiovascular Risk in womEn With polycyStic Ovary Syndrome; SUCCESS Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Leicester
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- we aim for a 2000 steps increase in Number of steps per day
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •Pregnancy
- •Involvement in other research studies with similar nature
Arms & Interventions
Intervention
Lifestyle education intervention
Intervention: Structured Lifestyle Education (Behavioral)
Control
The control group will receive an information leaflet which is generally distributed in our speciality clinic to patients with diagnosis of PCOS. The leaflet includes general information on PCOS, treatment options and advice on increasing physical activity.
Outcomes
Primary Outcomes
we aim for a 2000 steps increase in Number of steps per day
Time Frame: One year
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).
Secondary Outcomes
- Physical Activity(One year)
- Biochemical variables(One year)
- Anthropometric and demographic(One year)
- Health Related Quality of Life(One Year)
- Exercise and Barrier Self Efficacy(One Year)
- Epworth Sleepiness Scale(One Year)
- Body Fat Composition(One Year)
- Brief Illness Perception(One Year)