NCT02212873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

August 5, 2014

Last Update Submit

September 21, 2015

Conditions

OverweightObese

Keywords

school based interventionoverweightobeseBMI z scorefat mass

Outcome Measures

Primary Outcomes (1)

  • BMI z-score

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

    32 weeks of intervention

Secondary Outcomes (1)

  • Percentage body fat

    32 weeks of intervention

Study Arms (2)

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.

Other: MyBFF@school program

Interventions

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.

MyBFF@school program

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Putrajaya, Kuala Lumpur, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 39523406DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wan Nazaimoon Wan Mohamud, PhD

    Institute for Medical Research, Ministry of Health Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 8, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

MY(1)