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My Body is Fit and Fabulous at School (MyBFF@school)

Primary Purpose

Overweight, Obese

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
MyBFF@school program
Sponsored by
Ministry of Health, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring school based intervention, overweight, obese, BMI z score, fat mass

Eligibility Criteria

7 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • SKPP/ SMK Presint 9(1), 9(2), 11(1), 14(1)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

MyBFF@school program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

BMI z-score
The primary outcome is reduction in the BMI z-score of participating students.

Secondary Outcome Measures

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).

Full Information

First Posted
August 5, 2014
Last Updated
September 21, 2015
Sponsor
Ministry of Health, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT02212873
Brief Title
My Body is Fit and Fabulous at School
Acronym
MyBFF@school
Official Title
School-based Intervention Program - My Body is Fit and Fabulous
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Malaysia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese
Keywords
school based intervention, overweight, obese, BMI z score, fat mass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
MyBFF@school program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
MyBFF@school program
Intervention Description
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.
Primary Outcome Measure Information:
Title
BMI z-score
Description
The primary outcome is reduction in the BMI z-score of participating students.
Time Frame
32 weeks of intervention
Secondary Outcome Measure Information:
Title
Percentage body fat
Description
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).
Time Frame
32 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan Nazaimoon Wan Mohamud, PhD
Organizational Affiliation
Institute for Medical Research, Ministry of Health Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
SKPP/ SMK Presint 9(1), 9(2), 11(1), 14(1)
City
Putrajaya
State/Province
Wilayah Persekutuan
Country
Malaysia

12. IPD Sharing Statement

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