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.: PACTR201403000788422 Date of Approval: 12/03/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Community intervention to combat obesity and associated comorbidities in women
Official scientific title Community Intervention for Health to Increase Physical Activity and to Combat Obesity and its Associated Comorbidities in Women
Brief summary describing the background and objectives of the trial Obesity is a public health problem of increasing importance in both the developed and in the developing world. As of 2010, global estimates indicate that approximately 1.5 billion adults over 20 years of age are overweight and that more than 200 million men and nearly 300 million women are obese. The prevalence of obesity is increasing all over the world, leading to an increase in obesity-related health problems which are expected to have a serious impact on the physical and psychosocial well-being in the coming decades as well as on life expectancy, health care costs and national economies. The present study will be conducted in the 7 health districts of Alexandria and is designed to implement a program by ARC researchers acting as "health promoting agents" (HPAs) and to evaluate the effects on obesity and obesity comorbidities prevalence among women that promotes healthy lifestyle, including dietary and physical activity recommendations over 6 months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Obesity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/04/2014
Actual trial start date 01/04/2014
Anticipated date of last follow up 30/09/2014
Actual Last follow-up date 30/09/2014
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 500
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size =4) and the block size was not variable Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intervention group 6 months Nutrition, Physical activity and Awareness 250
Control Group Control group 6 months 250
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult women with a body mass index (BMI) above 28. Overweight/Obese women with severe/life-threatening organ disease and women with cognitive impairment. 21 Year(s) 70 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
No 15/03/2014 Ethical Committe of Alexandria University
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The overall prevalence of obesity. 6 months
Secondary Outcome Changes in measures of adiposity such as BMI and waist circumference, and incidence and remission of excess weight (overweight + obesity), as well as changes in lifestyles such as eating habits and physical activity. 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Regional Center for Women¿s Health and Development (ARC) Abdel Hamid Badawy Street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria Regional Center for Women¿s Health and Development (ARC) Abdel Hamid Badawy Street Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria Regional Center for Women¿s Health and Development (ARC) Abdel Hamid Badawy Street Alexandria Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Anna Abou-Raya Abdel Hamid Badawy Street Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Anna Abou-Raya annaaraya@yahoo.com 002-034832753 Abdel Hamid Badawy
City Postal code Country Position/Affiliation
Alexandria Egypt Head of the Research Dept.
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient information Manager
Role Name Email Phone Street address
Scientific Enquiries Anna Abou-Raya annaaraya@yahoo.com 002-034832753 Abdel Hamid Badawy
City Postal code Country Position/Affiliation
Alexandria Egypt Head of the Research Dept.
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information