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My Body is Fit and Fabulous at School Phase II

Primary Purpose

Overweight, Childhood

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MyBFF@school
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overweight, Childhood

Eligibility Criteria

9 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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)
    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.
    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)

    Secondary Outcome Measures

    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.
    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).
    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.
    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.
    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.
    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.
    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).
    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.
    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.
    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.
    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%).
    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%).
    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.
    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.
    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.
    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
    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
    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
    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
    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
    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

    Full Information

    First Posted
    October 6, 2019
    Last Updated
    November 4, 2019
    Sponsor
    University of Malaya
    Collaborators
    Ministry of Health, Malaysia, Ministry of Education, Malaysia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04155255
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (Actual)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Malaya
    Collaborators
    Ministry of Health, Malaysia, Ministry of Education, Malaysia

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight, Childhood

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2438 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    MyBFF@school
    Primary Outcome Measure Information:
    Title
    BMI z-score
    Description
    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.
    Time Frame
    Change from Baseline BMI z-score at 3 months and change from Baseline BMI z-score at 6 months
    Title
    Percentage of Body Fat (%)
    Description
    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)
    Time Frame
    Change from Baseline Body Fat Percentage at 3 months and change from Baseline Body Fat Percentage at 6 months
    Title
    Waist Circumference (cm)
    Description
    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.
    Time Frame
    Change from Baseline Waist Circumference at 3 months and change from Baseline Waist Circumference at 6 months
    Title
    Skeletal Muscle Mass (kg)
    Description
    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)
    Time Frame
    Change from Baseline Skeletal Muscle Mass at 3 months and change from Baseline Skeletal Muscle Mass at 6 months
    Secondary Outcome Measure Information:
    Title
    HbA1c Level
    Description
    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.
    Time Frame
    Change from Baseline HbA1c Level at 6 months.
    Title
    Fasting Plasma Glucose
    Description
    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).
    Time Frame
    Change from Baseline Fasting Plasma Glucose at 6 months.
    Title
    Total Cholesterol
    Description
    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.
    Time Frame
    Change from Baseline Total Cholesterol at 6 months.
    Title
    Triglycerides Level
    Description
    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.
    Time Frame
    Change from Baseline Triglycerides Level at 6 months.
    Title
    HDL-C Level
    Description
    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.
    Time Frame
    Change from Baseline HDL-C Level at 6 months.
    Title
    LDL-C Level
    Description
    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.
    Time Frame
    Change from Baseline LDL-C Level at 6 months.
    Title
    Fasting Insulin Level
    Description
    To see changes in Fasting Insulin Level. Fasting Insulin levels were measured using an automated enzyme immunoassay analyser (TOSOH AIA-360, Japan).
    Time Frame
    Change from Baseline Fasting Insulin Level at 6 months.
    Title
    HOMA-IR
    Description
    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.
    Time Frame
    Change from Baseline HOMA-IR at 6 months.
    Title
    TG:HDL-C Ratio
    Description
    To see changes in TG:HDL-C Ratio. TG:HDL-C Ratio is calculated by dividing triglycerides levels with HDL-C levels.
    Time Frame
    Change from Baseline TG:HDL-C Ratio at 6 months.
    Title
    Physical Fitness Score
    Description
    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.
    Time Frame
    Change from Baseline Physical Fitness Score at 3 months and change from Baseline Physical Fitness Score at 6 months
    Title
    Nutrition Knowledge
    Description
    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%).
    Time Frame
    Change in Nutrition Knowledge from Baseline to 6 months assessment
    Title
    Nutrition Attitude
    Description
    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%).
    Time Frame
    Change in Nutrition Attitude from Baseline to 6 months assessment
    Title
    Nutrition Practice
    Description
    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.
    Time Frame
    Change in Nutrition Practice from Baseline to 6 months assessment
    Title
    Stages of Change for Weight Management (Secondary School)
    Description
    To assess their behavioural changes via Stage of Change of Weight Management by using a validated Trans Theoretical Model Questionnaire for weight management behaviour.
    Time Frame
    Change in behaviour of weight management from Baseline to 6 months assessment
    Title
    Stages of Change for Fruit and Vegetable Intake (Secondary School)
    Description
    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.
    Time Frame
    Change from Baseline Stages of Change of Fruit and Vegetable Intake at 6 months
    Title
    Health-Related Quality of Life (Primary School)
    Description
    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
    Time Frame
    Change in behaviour of fruit and vegetable intake from Baseline to 6 months assessment
    Title
    Well-Being (Primary School)
    Description
    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
    Time Frame
    Change from Baseline Well-Being at 6 months
    Title
    Eating Attitude (Primary School)
    Description
    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
    Time Frame
    Change from Baseline Eating Attitude at 6 months
    Title
    Emotional and Psychological Well-Being (Secondary School)
    Description
    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
    Time Frame
    Change from Baseline Emotional and Psychological Well-Being at 6 months
    Title
    Eating Attitude (Secondary School)
    Description
    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
    Time Frame
    Change from Baseline Eating Attitude at 6 months
    Title
    Healthy Eating Behavior (Secondary School)
    Description
    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
    Time Frame
    Change from Baseline Healthy Eating Behavior at 6 months
    Other Pre-specified Outcome Measures:
    Title
    Blood Pressure
    Description
    To see changes in Blood Pressure. Blood Pressure reading was measured manually by trained staffs using a mercury sphygmomanometer (Accoson, UK) with appropriate cuff size for each individual.
    Time Frame
    Change from Baseline Blood Pressure at 6 months.
    Title
    Baseline Pubertal Status
    Description
    Pubertal Status was assessed (self-administered) using Tanner staging scale.
    Time Frame
    Baseline
    Title
    Pubertal Status Post-Intervention
    Description
    Pubertal Status was assessed (self-administered) using Tanner staging scale.
    Time Frame
    At 6 months
    Title
    Acanthosis Nigricans
    Description
    Participants were examined for the presence of acanthosis nigricans over the neck.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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: diagnosed type 2 diabetes mellitus hypertension nephritic syndrome epilepsy congenital heart disease skeletal anomalies On steroids On anti-epileptic On methylphenidate

    12. IPD Sharing Statement

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