Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-09-01
2021-10-31
Brief Summary
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Detailed Description
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The philosophy of the programme is based on patient empowerment. The structured group education programme will be based on psychological theories of learning including the Leventhal's common-sense theory, the dual-process theory, and the social learning theory. Similar to previous successful programmes in diabetes education and based on the experience gained by conducting the education programme "Living with type 2 diabetes" in our centre, the programme will be designed as a six-hour of education programme with a formal and informed curriculum. It will be offered in two three-hour sessions of teaching for 8-12 PCOS women at a time. Attendees will be encouraged to be accompanied by a person of their choice.
Initial thoughts on the curriculum and the format of the written material have been already discussed within our clinical and research team (Dr Papageorgiou, Professor Sathyapalan, Mrs Baldwin consultant endocrinologists, general practitioners and dietitian specialists/educators delivering the "Living with Diabetes" education programme for patients with type 2 diabetes) based on their experience and views expressed to them by women with PCOS. As such, the areas that will be covered in the structured education programme include:
* Thoughts and feelings of the participants around PCOS
* Understanding PCOS pathophysiology: what happens in the body
* Understanding the risk factors (e.g., obesity) and health risks associated with PCOS
* Emotional wellbeing and PCOS
* Management of PCOS symptoms -how to take control:
* Pharmacological options (i.e., hormonal contraceptives, anti-androgens, and insulin sensitisers)
* Lifestyle changes (i.e., basics of energy balance, healthy eating based on Eat well Plate, mindful eating, physical activity recommendations, practical advice).
* Planning for the future (e.g., family planning, screening for long-term conditions).
Importantly, the investigators are also going to conduct a patients' survey to find out what women with PCOS expect to gain from an educational programme addressing several aspects of PCOS. The investigators will use the collected data to further refine the aspects of PCOS that will be included in the final curriculum of the programme.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Group 1
Pilot the structured education in women with PCOS
Survey on patient's perspectives on the development of an structured education programme for PCOS
The outcome of this survey will help with developing curriculum for the structured education programme.
Pre-pilot questionnaire
The questionnaire is aimed to capture the knowledge and expectations of the participants from taking part in the educational sessions.
Piloting the structured education programme for PCOS
Piloting the education program through 2 educational group sessions
Post-pilot questionnaire
The questionnaire aimed to capture participant's satisfactions and knowledge gained by taking part in the pilot study
cognitive outcomes outcome evaluation form
This aimed to capture skills developed, knowledge gained and changes in participants behaviour and perceptions by taking part in the pilot study.
Interventions
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Survey on patient's perspectives on the development of an structured education programme for PCOS
The outcome of this survey will help with developing curriculum for the structured education programme.
Pre-pilot questionnaire
The questionnaire is aimed to capture the knowledge and expectations of the participants from taking part in the educational sessions.
Piloting the structured education programme for PCOS
Piloting the education program through 2 educational group sessions
Post-pilot questionnaire
The questionnaire aimed to capture participant's satisfactions and knowledge gained by taking part in the pilot study
cognitive outcomes outcome evaluation form
This aimed to capture skills developed, knowledge gained and changes in participants behaviour and perceptions by taking part in the pilot study.
Eligibility Criteria
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Inclusion Criteria
2. Women aged 18-50 years (inclusive), with a confirmed diagnosis of PCOS based on Rotterdam criteria.
3. Body mass index \> 25 kg/m²
Exclusion Criteria
2. Participants who cannot adequately understand verbal and written explanations given in English.
3. Lack of mental capacity to give written consent.
18 Years
50 Years
FEMALE
No
Sponsors
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British Dietetic Association
UNKNOWN
University of Hull
OTHER
Responsible Party
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Thozhukat Sathyapalan
Professor/ Honorary consultant Endocrinologist
Locations
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Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism
Hull, , United Kingdom
Countries
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Other Identifiers
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LW-PCOS V1.2020
Identifier Type: -
Identifier Source: org_study_id