Clinical trial NCT04155255: My Body is Fit and Fabulous at School Phase II
Official title: My Body is Fit and Fabulous: an Intervention Program to Combat Obesity Among Malaysian School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight, Childhood
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
name: Ministry of Education, Malaysia
First posted: 2019-11-07
Enrollment: 2438
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

  1. diagnosed type 2 diabetes mellitus
  2. hypertension
  3. nephritic syndrome
  4. epilepsy
  5. congenital heart disease
  6. skeletal anomalies
* On steroids
* On anti-epileptic
* On methylphenidate

Primary outcomes:
measure: BMI z-score
timeFrame: Change from Baseline BMI z-score at 3 months and change from Baseline BMI z-score at 6 months
measure: Percentage of Body Fat (%)
timeFrame: Change from Baseline Body Fat Percentage at 3 months and change from Baseline Body Fat Percentage at 6 months
measure: Waist Circumference (cm)
timeFrame: Change from Baseline Waist Circumference at 3 months and change from Baseline Waist Circumference at 6 months
measure: Skeletal Muscle Mass (kg)
timeFrame: Change from Baseline Skeletal Muscle Mass at 3 months and change from Baseline Skeletal Muscle Mass at 6 months
Secondary outcomes:
measure: HbA1c Level
timeFrame: Change from Baseline HbA1c Level at 6 months.
measure: Fasting Plasma Glucose
timeFrame: Change from Baseline Fasting Plasma Glucose at 6 months.
measure: Total Cholesterol
timeFrame: Change from Baseline Total Cholesterol at 6 months.
measure: Triglycerides Level
timeFrame: Change from Baseline Triglycerides Level at 6 months.
measure: HDL-C Level
timeFrame: Change from Baseline HDL-C Level at 6 months.
measure: LDL-C Level
timeFrame: Change from Baseline LDL-C Level at 6 months.
measure: Fasting Insulin Level
timeFrame: Change from Baseline Fasting Insulin Level at 6 months.
measure: HOMA-IR
timeFrame: Change from Baseline HOMA-IR at 6 months.
measure: TG:HDL-C Ratio
timeFrame: Change from Baseline TG:HDL-C Ratio at 6 months.
measure: Physical Fitness Score
timeFrame: Change from Baseline Physical Fitness Score at 3 months and change from Baseline Physical Fitness Score at 6 months
measure: Nutrition Knowledge
timeFrame: Change in Nutrition Knowledge from Baseline to 6 months assessment
measure: Nutrition Attitude
timeFrame: Change in Nutrition Attitude from Baseline to 6 months assessment
measure: Nutrition Practice
timeFrame: Change in Nutrition Practice from Baseline to 6 months assessment
measure: Stages of Change for Weight Management (Secondary School)
timeFrame: Change in behaviour of weight management from Baseline to 6 months assessment
measure: Stages of Change for Fruit and Vegetable Intake (Secondary School)
timeFrame: Change from Baseline Stages of Change of Fruit and Vegetable Intake at 6 months
measure: Health-Related Quality of Life (Primary School)
timeFrame: Change in behaviour of fruit and vegetable intake from Baseline to 6 months assessment
measure: Well-Being (Primary School)
timeFrame: Change from Baseline Well-Being at 6 months
measure: Eating Attitude (Primary School)
timeFrame: Change from Baseline Eating Attitude at 6 months
measure: Emotional and Psychological Well-Being (Secondary School)
timeFrame: Change from Baseline Emotional and Psychological Well-Being at 6 months
measure: Eating Attitude (Secondary School)
timeFrame: Change from Baseline Eating Attitude at 6 months
measure: Healthy Eating Behavior (Secondary School)
timeFrame: Change from Baseline Healthy Eating Behavior at 6 months
Other outcomes:
measure: Blood Pressure
timeFrame: Change from Baseline Blood Pressure at 6 months.
measure: Baseline Pubertal Status
timeFrame: Baseline
measure: Pubertal Status Post-Intervention
timeFrame: At 6 months
measure: Acanthosis Nigricans
timeFrame: Baseline
Locations:
Study officials:
References: