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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of Leicester.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Society for Endocrinology
Information provided by (Responsible Party):
University of Leicester
ClinicalTrials.gov Identifier:
NCT01462864
First received: October 18, 2011
Last updated: October 31, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Behavioral: Structured Lifestyle Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: StructUred eduCation Programme to Improve Cardiovascular Risk in womEn With polycyStic Ovary Syndrome; SUCCESS Study

Resource links provided by NLM:


Further study details as provided by University of Leicester:

Primary Outcome Measures:
  • we aim for a 2000 steps increase in Number of steps per day [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Physical Activity [ Time Frame: One year ] [ Designated as safety issue: No ]
    Physical activity will be objectively measured using the accelerometer and also IPAQ.

  • Biochemical variables [ Time Frame: One year ] [ Designated as safety issue: No ]
    • 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 Androsterendione. 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

  • Anthropometric and demographic [ Time Frame: One year ] [ Designated as safety issue: No ]
    • Blood pressure
    • Body weight
    • Body fat percentage

  • Health Related Quality of Life [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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.

  • Exercise and Barrier Self Efficacy [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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.

  • Epworth Sleepiness Scale [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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).

  • Body Fat Composition [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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.

  • Brief Illness Perception [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 160
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Intervention
Each individual in the intervention arm will be invited to participate in the tailored, structured self-management group education SUCCESS programme which will be developed in the earlier phases of the study.
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.
No Intervention: 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462864

Contacts
Contact: Hamidreza Mani, MD +44(0)1162047981 Hamidreza.Mani@uhl-tr.nhs.uk
Contact: Melanie Jane Davies, Prof (MD) +44 (0)1162046481 melanie.davies@uhl-tr.nhs.uk

Locations
United Kingdom
University Hospitals of Licester Recruiting
Leicester, Leicestershire, United Kingdom, LE1 5WW
Contact: Hamidreza Mani, MD    +44(0)1162047981    Hamidreza.Mani@uhl-tr.nhs.uk   
Principal Investigator: Melanie Jane Davies, Prof (MD)         
Sub-Investigator: Hamidreza Mani, MD         
Sponsors and Collaborators
University of Leicester
Society for Endocrinology
Investigators
Principal Investigator: Melanie Jane Davies, Prof (MD) University of Leicester
Study Chair: Kamlesh Khunti, Prof (PhD) University of Leicester
Study Director: Hamidreza Mani, MD University of Leicester
  More Information

No publications provided

Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT01462864     History of Changes
Other Study ID Numbers: UNOLE 0209
Study First Received: October 18, 2011
Last Updated: October 31, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Leicester:
Polycystic Ovary Syndrome
Lifestyle
Structured Education
Walking Activity
Exercise
Overweight
Impaired Glucose Regulation
Diabetes Prevention

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 18, 2014