Clinical trial NCT02212873: My Body is Fit and Fabulous at School
Official title: School-based Intervention Program - My Body is Fit and Fabulous
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Keywords: school based intervention
overweight
obese
BMI z score
fat mass
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
First posted: 2014-08-08
Enrollment: 332
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: BMI z-score
timeFrame: 32 weeks of intervention
Secondary outcomes:
measure: Percentage body fat
timeFrame: 32 weeks of intervention
Other outcomes:
Locations:
city: Putrajaya
country: Malaysia
facility: SKPP/ SMK Presint 9(1), 9(2), 11(1), 14(1)
state: Wilayah Persekutuan
Study officials:
affiliation: Institute for Medical Research, Ministry of Health Malaysia
name: Wan Nazaimoon Wan Mohamud, PhD
role: PRINCIPAL_INVESTIGATOR
References: