Polycystic Ovary SyndromeSUCCESSNCT01462864
Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome
A study testing Structured Lifestyle Education in people with Polycystic Ovary Syndrome, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Structured Lifestyle Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Licester
Leicester, Leicestershire, LE1 5WW
About this study
Official title: StructUred eduCation Programme to Improve Cardiovascular Risk in womEn With polycyStic Ovary Syndrome; SUCCESS Study
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.
Read more
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.
Read the 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.
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Structured Lifestyle Education
- Keywords
- Polycystic Ovary Syndrome, Lifestyle, Structured Education, Walking Activity, Exercise, Overweight, Impaired Glucose Regulation, Diabetes Prevention
- Medical subject headings
- Polycystic Ovary Syndrome, Motor Activity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Lifestyle EducationBehavioural
A 3-4 hours group education delivered in a patient group composed of 4-8 patients and delivered by two healthcare professionals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Lifestyle education intervention Receives: Behavioral: Structured Lifestyle Education |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
we aim for a 2000 steps increase in Number of steps per day
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).
Measured: One year
Secondary outcomes (8)
Physical Activity
Physical activity will be objectively measured using the accelerometer and also IPAQ.
Measured: One year
Biochemical variables
- Oral glucose tolerance test
- Blood lipid profile, liver and Kidney function test, albumin, vitamin D, calcium and full blood count.
- Hormonal assay; Follicular Stimulating Hormone (FSH), Luteinizing Hormone (LH), Testosterone, Sex Hormone Binding Globulin (SHBG), Dehydroepiandostrone (DHEAS), and Androstendione. Day 21 Progesterone level (unless on ovulation suppression medication).
- Insulin, HbA1c, HOMA-B, HOMA-IR
- hsCRP, TNF alpha, IL-6, and sIL-6R, fibrinogen, adiponectin
Measured: One year
Anthropometric and demographic
- Blood pressure
- Body weight
- Body fat percentage
Measured: One year
Health Related Quality of Life
PCOSQ is the only specified health related quality of life questionnaire developed and tested for this condition (Cronin 1998), which has been validated in UK (Jones 2004). It contains 26 items measuring 5 areas; emotions, body hair, weight, infertility problems, and menstrual problems.
Measured: One Year
Exercise and Barrier Self Efficacy
It will be measured using the 100% confidence rating scale (from 0% = no confidence to 100% = complete confidence) (Keller 1999). This self-efficacy questionnaire measures participants' confidence in their ability to undertake any form of moderate- to vigorous-intensity physical activity for 10 minute periods, increasing incrementally from 10 minutes to one hour each day. An overall score is calculated by summing the efficacy scores for each time period and dividing by the number of time periods.
Measured: One Year
Epworth Sleepiness Scale
The risk of Obstructive Sleep Apnoea (OSA) has been reported to be 5 to even 30 fold higher in women with PCOS (Nitsche 2010). Epworth Sleepiness Scale is the standard questionnaire developed for clinical assessment of behavioural morbidity associated with OSA and can assess the degree of sleepiness reliably as an screening tool. (Doghramii 2008).
Measured: One Year
Body Fat Composition
In a sub-study of the SUCCESS study population, a whole body dual energy X-ray absorptiometry (DEXA) scan and a single section abdominal magnetic resonance imaging (MRI) scan taken in the L3-L4 region will be used to measure soft tissue body composition and visceral and subcutaneous abdominal fat distribution respectively.
Measured: One Year
Brief Illness Perception
This nine item validated instrument uses an 11 point Likert scale (0 = no effect, 10 = complete effect) to measure five cognitive illness representations (consequences, timeline, personal control, treatment control, and identity), two emotional representations (concern and emotion) and illness comprehensibility (perceived knowledge). The BIPQ has been shown to have reasonable test-retest reliability and concurrent validity (Broadbent 2006).
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Endocrinology
- Responsible party
- Sponsor
- Investigators
- Melanie J Davies, Prof (MD), Principal investigator, University of LeicesterKamlesh Khunti, Prof (PhD), Study chair, University of LeicesterHamidreza Mani, MD, Study director, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462864
- Sponsor's protocol ID
- 0209
- Acronym
- SUCCESS
- Status last verified
- Oct 2011
- First submitted
- 18 Oct 2011
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StructUred eduCation Programme to Improve Cardiovascular Risk in womEn With polycyStic Ovary Syndrome; SUCCESS Study
- ClinicalTrials.gov ID
- NCT01462864
- Acronym / sponsor ID
- SUCCESS / 0209
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Lifestyle, Structured Education, Walking Activity, Exercise, Overweight, Impaired Glucose Regulation, Diabetes Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Society for Endocrinology
- Study start
- Sep 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Structured Lifestyle EducationLifestyle education intervention |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females aged between 18-50 years with the diagnosis of PCOS according to Rotterdam Criteria 2003 who are Overweight: (WHO 2010)
- If already on medical treatment for their PCOS, they should be on a stable regime for at least 6 months prior to the recruitment.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Lifestyle EducationA 3-4 hours group education delivered in a patient group composed of 4-8 patients and delivered by two healthcare professionals. | Behavioural | Intervention |
Primary outcome
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).
8 secondary outcomes
Physical Activity
Time frame: One year
Biochemical variables
Time frame: One year
Anthropometric and demographic
Time frame: One year
Health Related Quality of Life
Time frame: One Year
Exercise and Barrier Self Efficacy
Time frame: One Year
Epworth Sleepiness Scale
Time frame: One Year
Body Fat Composition
Time frame: One Year
Brief Illness Perception
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie J Davies, Prof (MD) principal investigator
University of Leicester
Kamlesh Khunti, Prof (PhD) study chair
University of Leicester
Hamidreza Mani, MD study director
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Lifestyle Education in people with Polycystic Ovary Syndrome, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
we aim for a 2000 steps increase in Number of steps per day (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.