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.: PACTR201907704486152 Date of Approval: 03/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Influence of Different Exercise Regimens on Segmental Body Fat in Obese Primary School Children.
Official scientific title Influence of Different Exercise Regimens on Segmental Body Fat in Obese Primary School Children.
Brief summary describing the background and objectives of the trial PURPOSE: to detect and compare the effect of different exercise Regimens on Segmental body fat in obese primary school children. BACKGROUND: Childhood obesity and physical inactivity are serious public health concerns. Obesity is associated with adverse health outcomes in children. Although exercise is recommended for obese children, the optimal exercise prescription to reduce adiposity and its co-morbidity is unclear.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/04/2019
Actual trial start date
Anticipated date of last follow up 30/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status 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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group non exercise group 6 months non exercise regimen just dietary counseling with a daily energy deficit of 250 kcal. 25 Dose Comparison
Experimental Group aerobic exercise group 3 time weekly 6 months dietary counseling (daily energy deficit of 250 kcal) with exercised on treadmills, elliptical machines, or bicycle ergo-meters 25
Experimental Group resistance exercise group 3 time weekly 6 months dietary counseling with a daily energy deficit of 250 kcal with selective resisted exercise program 25
Experimental Group combined aerobic and resistance exercise group 3 time weekly 6 months dietary counseling (daily energy deficit of 250 kcal) with combined program of aerobic and resistance exercises 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children be 6–12 years of age. their body mass index (BMI ) at or above the 95th percentile for age and sex physically inactive (no participation in structured physical activity for previous 3 months except school physical education classes participation in structured exercise, musculoskeletal disorders congenital anomalies cardiopulmonary problems endocrine disorders. Child: 6 Year-12 Year 6 Year(s) 12 Year(s) Both
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 15/04/2019 Faculty of Physical Therapy Research Ethics Officer
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432 Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Segmental Body Fat before and after 6 months of intervention
Secondary Outcome body mass index BMI before and after 6 months of interventions
Secondary Outcome waist/hip ratio before and after 6 months of interventions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Modern University for Technology and Information El-Moustashar Mohammed Mostafa, Al Abageyah, Qism El-Khalifa, Cairo Governorate Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Marian Magdy Shafeek khatem el-Morsalen street Giza Egypt
Amir Nazih Wadee Shorbra El-Khema Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Modern University for Technology and Information El-Moustashar Mohammed Mostafa, Al Abageyah, Qism El-Khalifa, Cairo Governorate Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amir Nazih Wadee Shobra El-Khema Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amir Wadee anazih@cu.edu.eg.com 002701222367919 Shobraa el-khema
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor
Role Name Email Phone Street address
Principal Investigator Marian Shafeek Marian.magdy2001@gmail.com 00270124037904 khatem El-Morsalen street
City Postal code Country Position/Affiliation
Giza Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Marian Shafeek Marian.magdy2001@gmail.com 00270124037904 khatem El-Mosalen street
City Postal code Country Position/Affiliation
Giza Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Amir Wadee anazih@cu.edu.eg.com 002701222367919 Shobraa el-khema
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes age,gender,BMI, segmental body fat ,W/H ratio Informed Consent Form 6 to 7 months Inclusion criteria included that the children be 6–12 years of age, their body mass index (BMI) at or above the 95th percentile for age and sex and physically inactive (no participation in structured physical activity for previous 3 months except school physical education classes).
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