My Body is Fit and Fabulous at School Phase II

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Overweight, Childhood

Intervention / Treatment
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* Other: MyBFF@school


Participation Criteria
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Eligibility Criteria
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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: diagnosed type 2 diabetes mellitus hypertension nephritic syndrome epilepsy congenital heart disease skeletal anomalies On steroids On anti-epileptic On methylphenidate

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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. | |
| Experimental: Intervention<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline HbA1c Level at 6 months. | 
| 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). | Change from Baseline Fasting Plasma Glucose at 6 months. | 
| 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. | Change from Baseline Total Cholesterol at 6 months. | 
| 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. | Change from Baseline Triglycerides Level at 6 months. | 
| 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. | Change from Baseline HDL-C Level at 6 months. | 
| 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. | Change from Baseline LDL-C Level at 6 months. | 
| 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). | Change from Baseline Fasting Insulin Level at 6 months. | 
| 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. | Change from Baseline HOMA-IR at 6 months. | 
| 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. | Change from Baseline TG:HDL-C Ratio at 6 months. | 
| 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. | Change from Baseline Physical Fitness Score at 3 months and change from Baseline Physical Fitness Score at 6 months | 
| 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%). | Change in Nutrition Knowledge from Baseline to 6 months assessment | 
| 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%). | Change in Nutrition Attitude from Baseline to 6 months assessment | 
| 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. | Change in Nutrition Practice from Baseline to 6 months assessment | 
| 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. | Change in behaviour of weight management from Baseline to 6 months assessment | 
| 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. | Change from Baseline Stages of Change of Fruit and Vegetable Intake at 6 months | 
| 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 | Change in behaviour of fruit and vegetable intake from Baseline to 6 months assessment | 
| 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 | Change from Baseline Well-Being at 6 months | 
| 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 | Change from Baseline Eating Attitude at 6 months | 
| 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 | Change from Baseline Emotional and Psychological Well-Being at 6 months | 
| 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 | Change from Baseline Eating Attitude at 6 months | 
| 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 | Change from Baseline Healthy Eating Behavior at 6 months |