Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202206710963782 Date of Approval: 07/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of structured Educational Sessions Regarding Lifestyle Modification on Health-Related Quality of Life among Women with Polycystic Ovary Syndrome: Randomized controlled trial
Official scientific title Effect of structured Educational Sessions Regarding Lifestyle Modification on Health-Related Quality of Life among Women with Polycystic Ovary Syndrome: Randomized controlled trial
Brief summary describing the background and objectives of the trial Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age (Norman, Dewailly, Legro, & Hickey, 2007). Worldwide, the prevalence of PCOS is 6-13%. In Egypt, it is estimated that the prevalence of PCOS is 13% in fertile and 37.5% in secondary infertile patient (Ahmad Sameer Sanad 2013). The symptoms of PCOS such as hirsutism, menstrual irregularity and infertility cause associated morbidities that generate negative consequences in the psychological and interpersonal functioning of individuals (El Hayek et al., 2016). PCOS has several serious complications. Estrogen levels are elevated, increasing risk of endometrial hyperplasia and, eventually, endometrial cancer. Androgen levels are often elevated, increasing the risk of metabolic syndrome and causing hirsutism. Hyperinsulinemia due to insulin resistance may be present and may contribute to increased ovarian production of androgens. Over the long term, androgen excess increases the risk of cardiovascular disorders, including hypertension. [8] Women with PCOS present an adverse reproductive profile, including a high risk of pregnancy-induced hypertension, preeclampsia, and gestational diabetes mellitus ((Palomba, et al 2015). As one of the important treatment strategies for PCOS patients, adjusting lifestyle to lose weight was helpful to improve endocrine disorders and reduce the risk of metabolic syndrome, which is widely used in clinical practice. For obese PCOS patients who receive assisted pregnancy treatment, dietary and exercise intervention before assisted pregnancy could help restore spontaneous ovulation and enhance natural pregnancy rate, improve the outcome of assisted pregnancy, increase the success rate of assisted pregnancy and reduce the risk of pregnancy complications((Wang 2019).). 1- Evaluate the effect of lifestyle modification program on quality of life among women with PCOS. 2- Determine the effects of lifestyle interventions on anthropo
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/01/2021
Actual trial start date
Anticipated date of last follow up 31/08/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 124
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control group the control group was managed expectantly 6 months control group 62 Placebo
Experimental Group educational group The educational group got knowledge regarding proper lifestyle for PCOS alongside medical treatment. 6 months health education followed by evaluation of the quality of life after intervention 62
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women aged 18- 45 years and b) diagnosed with PCOS according to Rotterdam criteria chronic medical diseases, b) psychiatric problems, and c) women refusing to participate in the study. Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/12/2020 research ethics committee faculty of nursing port said university
Ethics Committee Address
Street address City Postal code Country
orabi and el etihad street port said 0200 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Evaluate the effect of lifestyle modification program on quality of life among women with PCOS. 6 months
Secondary Outcome Determine the effects of lifestyle interventions on anthropometric and clinical parameters in women with PCOS. 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Eltakhassosy Obstetrics Hospital port said portsaid Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Asmaa AboBakr Ibrahim orabi and el etihad street port said 0200 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of nursing port said university orabi and el etihad street port said Egypt University
COLLABORATORS
Name Street address City Postal code Country
Asmaa AboBakr Ibrahim orabi and el etihad street port said Egypt
hanan mohamed ghoneim orabi and el etihad street port said Egypt
Nagat Salah Shalaby orabi and el etihad street port said Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator asmaa ibrahim asmaaibrahim@yahoo.com 01002365918 orabi and el etihad street
City Postal code Country Position/Affiliation
port said Egypt lecturer faculty of nursing port said university
Role Name Email Phone Street address
Public Enquiries hanan ghoneim hananghoneim@gmail.com 01223423685 orabi and el etihad street
City Postal code Country Position/Affiliation
port said Egypt assistant professor faculty of medicine suez canal university
Role Name Email Phone Street address
Scientific Enquiries hanan ghoneim hananghoneim@gmail.com 01223423685 orabi and el etihad street
City Postal code Country Position/Affiliation
port said Egypt assistant professor faculty of medicine suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data sharing is possible upon request and after approval of the research ethics committee Study Protocol after completion of the study after approval of the research ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information