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Overweight, ChildhoodNCT04155255

My Body is Fit and Fabulous at School Phase II

A study testing MyBFF@school in people with Overweight, Childhood, run by University of Malaya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Overweight, Childhood
What is being tested?
MyBFF@school
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,438 participants
Where
No sites listed yet
Study dates
Feb 2016to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • nephritic syndrome
  • epilepsy
  • congenital heart disease
  • skeletal anomalies
  • On steroids
  • On anti-epileptic
  • On methylphenidate

About this study

Official title: My Body is Fit and Fabulous: an Intervention Program to Combat Obesity Among Malaysian School Children

"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.

Read the detailed description

"My Body is Fit and Fabulous" (MyBFF@school) is a school-based, cluster randomised controlled trial (C-RCT) study that primarily aimed to evaluate the effectiveness of MyBFF@school program on overweight and obese school childrens' BMI for age (BMI z-score) and body fat percentage at 3 and 6 months post intervention. Primary and secondary schools in the central region of Peninsular Malaysia were randomised to either intervention or control school via systematic random sampling method. The selected intervention schools underwent MyBFF@school programme that consisted of physical activity, nutrition and psychology modules, whereas the control schools followed the standard national school curriculum.

Being tested
MyBFF@school
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MyBFF@schoolOther

Study groups in NCT04155255
Study groupRoleWhat they receive
ControlNo interventionAge-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.
InterventionExperimentalOverweight 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.
Receives: Other: MyBFF@school

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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)

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

  3. 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.

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

  4. 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)

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

Secondary outcomes (21)

  1. HbA1c Level

    To see changes in HbA1c Level. HbA1c level was determined by cationic exchanged high performance liquid chromatography (Adams A1c HA-8160, Arkray Inc, Japan) and followed the National Glycohemoglobin Standardization Programme Guidelines.

    Measured: Change from Baseline HbA1c Level at 6 months.

  2. Fasting Plasma Glucose

    To see changes in Fasting Plasma Glucose. Fasting Plasma Glucose was analysed by Randox Laboratories (Antrim, UK) using an auto chemical analyser (Dirui CS-400, China).

    Measured: Change from Baseline Fasting Plasma Glucose at 6 months.

  3. Total Cholesterol

    To see changes in Total Cholesterol. Total Cholesterol was analysed by Randox Laboratories (Antrim, UK) using an auto chemical analyser (Dirui CS-400, China). The cut-off value for high Total Cholesterol is 5.20 mmol/L.

    Measured: Change from Baseline Total Cholesterol at 6 months.

  4. Triglycerides Level

    To see changes in Triglycerides Level. Triglycerides Level was analysed by Randox Laboratories (Antrim, UK) using an auto chemical analyser (Dirui CS-400, China). The cut-off value for high Triglycerides Level is 1.70 mmol/L.

    Measured: Change from Baseline Triglycerides Level at 6 months.

  5. HDL-C Level

    To see changes in HDL-C Level. HDL-C Level was analysed by Randox Laboratories (Antrim, UK) using an auto chemical analyser (Dirui CS-400, China). The cut-off value for low HDL-C Level is 1.03 mmol/L.

    Measured: Change from Baseline HDL-C Level at 6 months.

  6. LDL-C Level

    To see changes in LDL-C Level. LDL-C Level was analysed by Randox Laboratories (Antrim, UK) using an auto chemical analyser (Dirui CS-400, China). The cut-off value for high LDL-C Level is 2.84 mmol/L.

    Measured: Change from Baseline LDL-C Level at 6 months.

  7. Fasting Insulin Level

    To see changes in Fasting Insulin Level. Fasting Insulin levels were measured using an automated enzyme immunoassay analyser (TOSOH AIA-360, Japan).

    Measured: Change from Baseline Fasting Insulin Level at 6 months.

  8. HOMA-IR

    To see changes in HOMA-IR. HOMA-IR is calculated by multiplying the value of fasting insulin and fasting plasma glucose and divided by 22.5.

    Measured: Change from Baseline HOMA-IR at 6 months.

  9. TG:HDL-C Ratio

    To see changes in TG:HDL-C Ratio. TG:HDL-C Ratio is calculated by dividing triglycerides levels with HDL-C levels.

    Measured: Change from Baseline TG:HDL-C Ratio at 6 months.

  10. Physical Fitness Score

    To see changes in Physical Fitness Score. Physical Fitness Score was assessed using Modified Harvard Step Test. Physical Fitness Score was calculated with this formula: (Total duration in seconds/Total pulse rate at 0, 1 and 2 minutes) X 100. After the calculation of the physical fitness score, the subjects' physical fitness were categorized into 5 different categories. The first category was poor, where the score of their physical fitness score is below 54. The second was low average, as their physical fitness score falls between the range of 55 to 64. Next, high average with the score between 65 to 79 followed by the fourth category which was good i.e. between the ranges of 80 to 89. Lastly, the fifth category was excellent, where the subjects' physical fitness score were more than 90.

    Measured: Change from Baseline Physical Fitness Score at 3 months and change from Baseline Physical Fitness Score at 6 months

  11. Nutrition Knowledge

    To assess their changes of Nutrition Knowledge using a pre-tested Nutrition Knowledge using a validated Nutrition Knowledge Questionnaire. The school children completed a 10-item True/ False/ Don't know Nutrition Knowledge questionnaire before and after intervention. The correct answer was given a score of 1 whereas for the wrong answer and I don't know was given a score of 0. The total score for every respondent was calculated from the correct responses with a maximum of 10 points which were then converted to percentages. Total scores for the knowledge items were then ranked into 3 tertiles; lowest (≤50%), middle (60%) and highest (70-100%).

    Measured: Change in Nutrition Knowledge from Baseline to 6 months assessment

  12. Nutrition Attitude

    To assess their changes of Nutrition Attitude using a pre-tested Nutrition Attitude Questionnaire. There were 15 questions for the attitude items. The attitude items were on a five-point Likert scale ranging from strongly disagree (1 point) to strongly agree (5 points). An intermediate (neutral) option was allocated 3 points. Total scores for the attitude items were then ranked into 3 tertiles; lowest (≤50%), middle (60%) and highest (70-100%).

    Measured: Change in Nutrition Attitude from Baseline to 6 months assessment

  13. Nutrition Practice

    To assess their changes of Nutrition Practice using a pre-tested Nutrition Practice Questionnaire. Assessment focused mainly on the key components that should be and commonly practiced by the school children. These included intake of fruit and vegetable, plain water, carbonated drinks, breakfast intake a swell as food commonly brought food from home and also food commonly purchased from the school canteen.

    Measured: Change in Nutrition Practice from Baseline to 6 months assessment

  14. Stages of Change for Weight Management (Secondary School)

    To assess their behavioural changes via Stage of Change of Weight Management by using a validated Trans Theoretical Model Questionnaire for weight management behaviour.

    Measured: Change in behaviour of weight management from Baseline to 6 months assessment

  15. Stages of Change for Fruit and Vegetable Intake (Secondary School)

    To assess their behavioural changes via Stage of Change of Fruit and Vegetable Intake by using a validated Trans Theoretical Model Questionnaire for fruit and vegetable intake behaviour.

    Measured: Change from Baseline Stages of Change of Fruit and Vegetable Intake at 6 months

  16. Health-Related Quality of Life (Primary School)

    To assess their changes of Health-Related Quality of Life using KINDL-R questionnaire. It contains 24 Likert-scaled items that are associated with 6 subscales namely physical well-being, emotional well-being, self-esteem, friend, family and school functioning. Total scores are obtained by adding the scores of all subscales. Higher scores represent better outcome. Range score from 15 to 75

    Measured: Change in behaviour of fruit and vegetable intake from Baseline to 6 months assessment

  17. Well-Being (Primary School)

    To assess their changes of Well-Being using the Stirling Children Well-being Scale (SCWBS) questionnaire. It is comprised of two subscales which are positive outlook and positive emotional state. Total scores are obtained by adding the scores of all subscales. Higher scores represent better outcome. Range score from 24 to 120

    Measured: Change from Baseline Well-Being at 6 months

  18. Eating Attitude (Primary School)

    To assess their changes of Eating Attitude using the Children' Eating Attitude Test (ChEAT) questionnaire. It is comprised of three subscales namely dieting, restricting and purging, food and oral control . Higher scores represent worse outcome. Range score from 26 to 156

    Measured: Change from Baseline Eating Attitude at 6 months

  19. Emotional and Psychological Well-Being (Secondary School)

    To assess their changes of Emotional and Psychological Well-Being using the Youth-Self Report questionnaire. YSR contains 112 items to measure emotional and behavioral problems comprising of 12 subscales which are anxious /depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behaviour, aggressive behaviour, other problems, internalizing, externalizing and total behaviour. Internalizing are the total sum of the subscales of anxious/depressed, withdrawn/depressed and somatic complaints. Externalizing are the total sum of rule-breaking behaviour and aggressive behaviour. Total behavior are the sume of all subscales. Higher scores represent worse outcome. Range score from 0 to 224

    Measured: Change from Baseline Emotional and Psychological Well-Being at 6 months

  20. Eating Attitude (Secondary School)

    To assess their changes of Eating Attitude using the Eating Attitude Test (EAT-26) questionnaire. It is comprised of three subscales namely dieting, bulimia and food preoccupation and oral control. Higher scores represent worse outcome. Range score from 30 to 180

    Measured: Change from Baseline Eating Attitude at 6 months

  21. Healthy Eating Behavior (Secondary School)

    To assess their changes of Healthy Eating Behavior using the Adolescents Food Habits Checklist. Higher scores represent better outcome. Range score from 0 to 46

    Measured: Change from Baseline Healthy Eating Behavior at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2019
  2. Study startFeb 2016
  3. Primary completionAug 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,438 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04155255
Sponsor's protocol ID
NMRR1343916563
Status last verified
Nov 2019
First submitted
6 Oct 2019
Last updated
7 Nov 2019
Results posted
No

Publications

  • 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.

    PubMed 40721745

  • 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.

    PubMed 40702531

  • 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.

    PubMed 39905418

  • 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.

    PubMed 39810108

  • 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.

    PubMed 39794750

  • 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.

    PubMed 39789494

  • 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.

    PubMed 39789486

  • 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.

    PubMed 39789464

Questions about this trial

What is this clinical trial studying?

A study testing MyBFF@school in people with Overweight, Childhood, run by University of Malaya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI z-score (time frame: Change from Baseline BMI z-score at 3 months and change from Baseline BMI z-score at 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04155255, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.

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