My Body is Fit and Fabulous at School

Overweight Clinical Trial

— MyBFF@school  

Official title:

School-based Intervention Program - My Body is Fit and Fabulous

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212873
• Other study ID #: NMRR1343916563
• Status: Completed
• Phase: N/A
• First received: August 5, 2014
• Last updated: September 21, 2015
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Ministry of Health, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 16 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obese
• Overweight

Intervention

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.

Locations

Country	Name	City	State
Malaysia	SKPP/ SMK Presint 9(1), 9(2), 11(1), 14(1)	Putrajaya	Wilayah Persekutuan

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI z-score	The primary outcome is reduction in the BMI z-score of participating students.	32 weeks of intervention	No
Secondary	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).	32 weeks of intervention	No