NCT04155255

Brief Summary

"My Body is Fit and Fabulous" (MyBFF@school) program was designed specifically for overweight and obese school children in order to help them control their BMI and body fat. MyBFF@school is a multi-faceted obesity intervention program that incorporated physical activity, nutrition and psychology modules.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,438

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

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, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

October 6, 2019

Last Update Submit

November 4, 2019

Conditions

Overweight, Childhood

Outcome Measures

Primary Outcomes (4)

  • BMI z-score

    To see changes in BMI z-score. Also called as BMI standard deviation scores, which measures relative weight adjusted for child age and sex. Weight in kilograms and height in meters will be combined to report BMI in kg/m\^2. By using the value of BMI obtained, BMI z-score was calculated using World Health Organization (WHO) AnthroPlus 2007 software, with indication of overweight \>+1.0 SD, obese \>+2.0 SD and morbidly obese \>+3.0 SD.

    Change from Baseline BMI z-score at 3 months and change from Baseline BMI z-score at 6 months

  • Percentage of Body Fat (%)

    To see changes in percentage of body fat. It is the percentage of body weight that is made up of fat. It consists of both storage body fat and essential body fat. It was measured in light clothing without shoes and socks to the nearest 0.1 kg using a pre-calibrated body impedance analyser (InBody 770, Korea)

    Change from Baseline Body Fat Percentage at 3 months and change from Baseline Body Fat Percentage at 6 months

  • Waist Circumference (cm)

    To see changes in Waist Circumference. Waist Circumference was measured twice to the nearest 0.1 cm over the skin midway between the tenth rib and the iliac crest at the end of normal expiration, using a non-extensible tape.

    Change from Baseline Waist Circumference at 3 months and change from Baseline Waist Circumference at 6 months

  • Skeletal Muscle Mass (kg)

    To see changes in Skeletal Muscle Mass. Skeletal Muscle Mass is the weight of muscles that connected to the bones in the body that were measured in light clothing without shoes and socks to the nearest 0.1 kg using a pre-calibrated body impedance analyser (InBody 770, Korea)

    Change from Baseline Skeletal Muscle Mass at 3 months and change from Baseline Skeletal Muscle Mass at 6 months

Secondary Outcomes (21)

  • HbA1c Level

    Change from Baseline HbA1c Level at 6 months.

  • Fasting Plasma Glucose

    Change from Baseline Fasting Plasma Glucose at 6 months.

  • Total Cholesterol

    Change from Baseline Total Cholesterol at 6 months.

  • Triglycerides Level

    Change from Baseline Triglycerides Level at 6 months.

  • HDL-C Level

    Change from Baseline HDL-C Level at 6 months.

  • +16 more secondary outcomes

Other Outcomes (4)

  • Blood Pressure

    Change from Baseline Blood Pressure at 6 months.

  • Baseline Pubertal Status

    Baseline

  • Pubertal Status Post-Intervention

    At 6 months

  • +1 more other outcomes

Study Arms (2)

Control

NO INTERVENTION

Age-matched overweight and obese students were selected from control schools. The students participated in their usual health and physical education classes plus any other curriculum activities provided by the school.

Intervention

EXPERIMENTAL

Overweight and obese students were recruited from intervention schools. Students underwent MyBFF@school intervention programme that consisted of physical activity, nutrition and psychological modules for the duration of 6 months. MyBFF@school intervention programme were conducted by trained personnel that were stationed full-time at each intervention school.

Other: MyBFF@school

Interventions

MyBFF@schoolOTHER
Intervention

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Give consent
  • Overweight and obese students with BMI for age (BMI z-score) more than +1SD based on WHO 2007 Growth Reference
  • Age between 9-16 years old

You may not qualify if:

  • BMI for age below and equal +1SD
  • Physical or mental disability
  • Medical conditions that prevent him/her to participate in moderate-to-vigorous physical activity
  • Co-morbidities that may interfere with the study such as:
  • diagnosed type 2 diabetes mellitus
  • hypertension
  • nephritic syndrome
  • epilepsy
  • congenital heart disease
  • skeletal anomalies
  • On steroids
  • On anti-epileptic
  • On methylphenidate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Ishak Z, Fin LS, Ibrahim WAHW, Yahya A, Zain FM, Selamat R, Jalaludin MY, Mokhtar AH. The effectivess of MyBFF@school intervention program in reducing emotional and behavioral problems in overweight and obese secondary schoolchildren in Malaysia: a cluster randomized controlled trial. BMC Public Health. 2025 Jul 28;24(Suppl 1):3631. doi: 10.1186/s12889-025-23545-y.

    PMID: 40721745DERIVED

  • Jalaludin MY, Zin RMWM, Roslan FA, Mansor F, Zain FM, Hong JYH, Kamil NZIA, Yahya A, Ishak Z, Selamat R, Mokhtar AH. Cardiometabolic outcome of MyBFF@school intervention program among primary schoolchildren: a cluster randomized controlled trial. BMC Public Health. 2025 Jul 24;24(Suppl 1):3630. doi: 10.1186/s12889-025-23546-x.

    PMID: 40702531DERIVED

  • Selamat R, Aziz NAA, Raib J, Zulkafly N, Mohamad WAW, Ismail AN, Jalaludin MY, Zain FM, Ishak Z, Yahya A, Mokhtar AH. Effects of a nutrition education intervention on nutrition knowledge and attitude among overweight and obese primary schoolchildren: a cluster randomized controlled trial. BMC Public Health. 2025 Feb 4;24(Suppl 1):3629. doi: 10.1186/s12889-025-21671-1.

    PMID: 39905418DERIVED

  • Zin RMWM, Mokhtar AH, Yahya A, Zain FM, Selamat R, Ishak Z, Jalaludin MY. Effects of MyBFF@school, a multifaceted obesity intervention program, on anthropometry and body composition of overweight and obese primary schoolchildren. BMC Public Health. 2025 Jan 14;24(Suppl 1):3627. doi: 10.1186/s12889-024-20724-1.

    PMID: 39810108DERIVED

  • Mokhtar AH, Zin RMWM, Yahya A, Zain FM, Selamat R, Ishak Z, Jalaludin MY. Rationale, design, and methodology of My Body Is Fit and Fabulous at school (MyBFF@school) study: a multi-pronged intervention program to combat obesity among Malaysian schoolchildren. BMC Public Health. 2025 Jan 10;24(Suppl 1):3626. doi: 10.1186/s12889-024-20726-z.

    PMID: 39794750DERIVED

  • Selamat R, Raib J, Aziz NAA, Zulkafly N, Ismail AN, Mohamad WNAW, Zulkiply AA, Jalaludin MY, Zain FM, Ishak Z, Yahya A, Mokhtar AH. Effects of the MyBFF@school obesity intervention program with nutrition education intervention on nutrition knowledge and attitude of secondary schoolchildren: a cluster randomized controlled trial. BMC Public Health. 2025 Jan 9;24(Suppl 1):3624. doi: 10.1186/s12889-024-21090-8.

    PMID: 39789494DERIVED

  • Kamil NZIA, Mokhtar AH, Yahya A, Zain FM, Selamat R, Ishak Z, Jalaludin MY. Effects of the MyBFF@school program on anthropometry and body composition among overweight and obese adolescent schoolchildren. BMC Public Health. 2025 Jan 9;24(Suppl 1):3625. doi: 10.1186/s12889-024-20725-0.

    PMID: 39789486DERIVED

  • Mokhtar AH, Kamarudin MA, Choong A, Singh L, Genisan V, Yahya A, Zin RMWM, Zain FM, Selamat R, Ishak Z, Jalaludin MY. The effect of the MyBFF@school program on cardiorespiratory fitness in overweight and obese primary schoolchildren: a cluster randomized controlled trial. BMC Public Health. 2025 Jan 9;24(Suppl 1):3623. doi: 10.1186/s12889-024-20723-2.

    PMID: 39789464DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2019

First Posted

November 7, 2019

Study Start

February 1, 2016

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

November 7, 2019

Record last verified: 2019-11