OverweightMyBFF@schoolNCT02212873
My Body is Fit and Fabulous at School
A study testing MyBFF@school program in people with Overweight and Obese, run by Ministry of Health, Malaysia at 1 site in Malaysia.
Trial summary
In order to address and curb the high prevalence of childhood obesity in Malaysia, a school-based intervention program, MyBFF@school is developed for implementation in all schools in the country. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- MyBFF@school program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteMalaysia
- Study dates
- Feb 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Classified as overweight and obese based on BMI of 85th percentile and above, according to WHO growth chart.
- No medical conditions that could endanger their health when participating in MyBFF@school.
- Obtained parental and assent consents.
Who cannot join
- With either physical or mental disability. With medical condition that prevents him/her to participate in moderate-to-vigorous intensity physical activity.
- With comorbidities that may interfere with the study such as diagnosed type 2 diabetes mellitus, hypertension, nephritic syndrome, epilepsy, congenital heart disease and skeletal anomalies.
- On steroids, on anti-epileptics and on methylphenidate.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
SKPP/ SMK Presint 9(1), 9(2), 11(1), 14(1)
Putrajaya, Kuala Lumpur
About this study
Official title: School-based Intervention Program - My Body is Fit and Fabulous
In order to address and curb the high prevalence of childhood obesity in Malaysia, a school-based intervention program, MyBFF@school is developed for implementation in all schools in the country. The program is specific for overweight and obese students and it is hypothesized that by participating in this program, students will be able to control their body mass index.
Read the detailed description
A nationwide Nutrition Survey of Malaysian Children carried out between 2008-2009 among 3542 children aged from 6 months to 12 years showed a prevalence of 9.8% overweight and 11.8% obesity while in a more recent 2011 Global School-based Student Heath Survey showed that the percentage of overweight and obese Malaysian school children age 13-15 years old was 25.4% and 10.9% respectively . If left unchecked, these children will grow up to be obese adults, developed various obesity-related complications such as cardiovascular diseases, diabetes etc. Realising the urgent needs to address the problems, the Ministry of Health Malaysia with the cooperation of the Ministry of Education, proposed to implement MyBFF@school in all schools in Malaysia. Students participating in MyBFF@school will take part in a structured physical activity in the form of small sided football game (SSG), and are to attend intensified and interactive nutrition and psychology classes aimed at improving their knowledge, self-esteem and self-empowerment.
- Conditions
- Overweight, Obese
- Being tested
- MyBFF@school program
- Keywords
- school based intervention, overweight, obese, BMI z score, fat mass
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyBFF@school programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| MyBFF@school program | Experimental | 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. Receives: Other: MyBFF@school program |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z-score
The primary outcome is reduction in the BMI z-score of participating students.
Measured: 32 weeks of intervention
Secondary outcomes (1)
Percentage body fat
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).
Measured: 32 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wan Nazaimoon WM, Ministry of Health, Malaysia
- Investigators
- Wan Nazaimoon Wan Mohamud, PhD, Principal investigator, Institute for Medical Research, Ministry of Health Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212873
- Sponsor's protocol ID
- NMRR1343916563
- Acronym
- MyBFF@school
- Status last verified
- Sep 2015
- First submitted
- 5 Aug 2014
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wan Mohd Zin RM, Jalaludin MY, Md Zain F, Hong JYH, Ahmad Kamil NZI, Mokhtar AH, Wan Mohamud WN. Lifestyle intervention improves cardiometabolic profiles among children with metabolically healthy and metabolically unhealthy obesity. Diabetol Metab Syndr. 2024 Nov 11;16(1):268. doi: 10.1186/s13098-024-01493-8.
PubMed 39523406
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-based Intervention Program - My Body is Fit and Fabulous
- ClinicalTrials.gov ID
- NCT02212873
- Acronym / sponsor ID
- MyBFF@school / NMRR1343916563
- Conditions
- Overweight, Obese
- Keywords
- school based intervention, overweight, obese, BMI z score, fat mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to address and curb the high prevalence of childhood obesity in Malaysia, a school-based intervention program, MyBFF@school is developed for implementation in all schools in the country. The program is specific for overweight and obese students and it is hypothesized that by participating in this program, students will be able to control their body mass index.
Detailed description
A nationwide Nutrition Survey of Malaysian Children carried out between 2008-2009 among 3542 children aged from 6 months to 12 years showed a prevalence of 9.8% overweight and 11.8% obesity while in a more recent 2011 Global School-based Student Heath Survey showed that the percentage of overweight and obese Malaysian school children age 13-15 years old was 25.4% and 10.9% respectively . If left unchecked, these children will grow up to be obese adults, developed various obesity-related complications such as cardiovascular diseases, diabetes etc. Realising the urgent needs to address the problems, the Ministry of Health Malaysia with the cooperation of the Ministry of Education, proposed to implement MyBFF@school in all schools in Malaysia. Students participating in MyBFF@school will take part in a structured physical activity in the form of small sided football game (SSG), and are to attend intensified and interactive nutrition and psychology classes aimed at improving their knowledge, self-esteem and self-empowerment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| MyBFF@school program | Experimental | Other: MyBFF@school programStudents 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. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Classified as overweight and obese based on BMI of 85th percentile and above, according to WHO growth chart.
- No medical conditions that could endanger their health when participating in MyBFF@school.
- Obtained parental and assent consents.
Key exclusion criteria (3 listed)
- With either physical or mental disability. With medical condition that prevents him/her to participate in moderate-to-vigorous intensity physical activity.
- With comorbidities that may interfere with the study such as diagnosed type 2 diabetes mellitus, hypertension, nephritic syndrome, epilepsy, congenital heart disease and skeletal anomalies.
- On steroids, on anti-epileptics and on methylphenidate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyBFF@school programStudents 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. | Other | MyBFF@school program |
Primary outcome
BMI z-score
Time frame: 32 weeks of intervention
The primary outcome is reduction in the BMI z-score of participating students.
1 secondary outcome
Percentage body fat
Time frame: 32 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Derived from this study: PubMed 39523406Wan Mohd Zin RM, Jalaludin MY, Md Zain F, Hong JYH, Ahmad Kamil NZI, Mokhtar AH, Wan Mohamud WN. Lifestyle intervention improves cardiometabolic profiles among children with metabolically healthy and metabolically unhealthy obesity. Diabetol Metab Syndr. 2024 Nov 11;16(1):268. doi: 10.1186/s13098-024-01493-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan Nazaimoon Wan Mohamud, PhD principal investigator
Institute for Medical Research, Ministry of Health Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyBFF@school program in people with Overweight and Obese, run by Ministry of Health, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI z-score (time frame: 32 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02212873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.