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.: PACTR201911724355280 Date of Approval: 18/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect Of Weight Loss on Menopausal Symptoms and Inflammatory Biomarkers in Post-Menopausal Women
Official scientific title Effect Of Weight Loss on Menopausal Symptoms and Inflammatory Biomarkers in Post-Menopausal Women
Brief summary describing the background and objectives of the trial Weight loss has a dramatic effect on an individual's quality of life. This study aims to assess the effect of weight loss on menopausal symptoms and inflammatory biomarker C-reactive proteins (CRP) among postmenopausal women
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 menopausal symptoms improvement
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2019
Actual trial start date
Anticipated date of last follow up 01/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 6 months 6 months expectant management 31 Placebo
Experimental Group diet and excercise group The caloric restriction diet intervention was a modification of the (Diabetes Prevention Program) DPP (20) and the Look (AHEAD) trial lifestyle interventions (21) which were designed to produce an average loss of 7% to 9% of initial body weight by 6 months. This included monthly 1-hour group sessions led by experts in nutrition, exercise, and behavior change during which women will be encouraged to increase physical activity to at least 200 minutes per week using brisk walking or activities of similar intensity and to record exercise time daily. In addition, women were instructed to follow a reduced-calorie diet (1200–1500 kcal/d), offered sample meal plans modeling with low fat high fiber regimen. 6 months diet and excercise group 31
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. postmenopausal women (natural menopause) b. Patient with BMI (25-35) c. Patient with no chronic or serious disease (diabetic, cancer) a. Using of postmenopausal hormone therapy within the prior 3 months b. Women with oophorectomy. c. Using of weight loss medications. d. Any joint disease interferes with movement (osteoarthritis). e. Those with mental or physical condition that could interfere with the understanding of the questionnaire Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 64 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 27/05/2019 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. To measure the association of body mass index (BMI) and body fat distribution with postmenopausal symptom. 2. To study the effect of postmenopausal obesity on C-reactive proteins (CRP). 6 months
Secondary Outcome To assess weight loss effect on inflammatory biomarker (CRP). 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dalia Hassan ElMenawy ring road kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dalia Hassan ElMenawy ring road kilo 4.5 ismailia Egypt
omima tharwat taha ring road kilo 4.5 ismailia Egypt
Mohamed Ahmed Elbahy ring road kilo 4.5 ismailia Egypt
Mariam Lotfy Mohamed ring road kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dalia ElMenawy dolcemeno@gmail.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Scientific Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes sharing data will be through the available results published and after approval of our research ethics committee Study Protocol 1 month after trial completion after approval of our research ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes There is statistically non-significant difference between the studied groups regarding age or duration of menopause.There is statistically non-significant difference between the studied groups regarding BMI at the start of the study while there is significant difference between them regarding BMI by the end of the study. In intervention group, there is significant decrease in BMI by the end while in control group, there is non-significant change in BMI.There is statistically non-significant difference between the studied groups regarding CRP at the start of the study while there is significant difference between them regarding CRP by the end of the study. In intervention group, there is significant decrease in CRP by the end while in control group, there is non-significant change in CRP. 20/09/2019 24/10/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.dropbox.com/s/vf2ft40p7mqqeua/final%20revision.docx?dl=0
Changes to trial information