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

NCT01462864 | Completed

• 1 other identifier: 0209
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; Lifestyle; Structured Education; Walking Activity; Exercise; Overweight; Impaired Glucose Regulation; Diabetes Prevention

Outcome Measures

Primary Outcomes (1)

• 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).

  One year

Secondary Outcomes (8)

• 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

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Lifestyle education intervention

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.

Interventions

Structured Lifestyle Education BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead
• Society for Endocrinology: collaborator

Study Sites (1)

University Hospitals of Licester

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Motor Activity; Overweight

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melanie J Davies, Prof (MD)

  University of Leicester

  PRINCIPAL INVESTIGATOR

• Kamlesh Khunti, Prof (PhD)

  University of Leicester

  STUDY CHAIR

• Hamidreza Mani, MD

  University of Leicester

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: November 1, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 30, 2020

Record last verified: 2011-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)