My Body is Fit and Fabulous at School (MyBFF@school)
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|ClinicalTrials.gov Identifier: NCT02212873|
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : September 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obese||Other: MyBFF@school program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||332 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||School-based Intervention Program - My Body is Fit and Fabulous|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||December 2014|
No Intervention: Control
Equal number of age-matched overweight and obese students will be selected from a control school. There will be no intervention, and students will participate in their usual health and physical education classes plus any other curriculum activities provided by the school.
Experimental: MyBFF@school program
Students will participate in all 3 components of MyFF@school for a total of 32 weeks; 1-hour of SSG thrice weekly plus 30 to 45 minutes of either nutrition or psychology classes once a week. All students including those in the control arm will be assessed at baseline, week-16 and at end of the study. They will undergo anthropometric measurements, body fat assessment, clinical examination and fitness test by modified Harvard step-test.
Other: MyBFF@school program
Students will be required to participate in all 3 components of MyBFF@school (SSG, nutrition and psychology sessions) for 16 weeks under the supervision of trained researchers, then for another 16 weeks supervised by their respective teachers-in-charge of physical education and/or co-curriculum activity. Each SSG session will be for an hour, thrice weekly while the nutrition or psychology session will be for 30-45 minutes once a week.
- BMI z-score [ Time Frame: 32 weeks of intervention ]The primary outcome is reduction in the BMI z-score of participating students.
- Percentage body fat [ Time Frame: 32 weeks of intervention ]Body fat of all participating students will be measured at baseline, week-16 and week-32 following intervention using Inbody 720 body composition analyzer (GE Healthcare).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212873
|SKPP/ SMK Presint 9(1), 9(2), 11(1), 14(1)|
|Putrajaya, Wilayah Persekutuan, Malaysia|
|Principal Investigator:||Wan Nazaimoon Wan Mohamud, PhD||Institute for Medical Research, Ministry of Health Malaysia|