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the Effectiveness of Health Literacy Intervention Among Middle Eastern Adolescents in Malaysia

Primary Purpose

Adolescents Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Education Intervention
No Intervention
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adolescents Obesity

Eligibility Criteria

13 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Arabic citizen students Aged 13 to 14 years Who at least one of their parents consented to participate in the study. Exclusion Criteria: Students with diseases such as asthma, diabetes, cancer, cardiovascular diseases, fractures, cirrhosis, or other diseases. Students with any medical condition who are not allowed to do physical activity.

Sites / Locations

  • Hanan Al-haroniRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intervention group

Control group: No Intervention

Arm Description

Intervention group: Participants assigned to the intervention group will receive both will receive educational intervention including educational booklet will be distributed to the participants in the first session, and they will be asked to take it home and read it within one week. The booklet's content will include the risk factors of NCD and the benefits of adopting a healthy diet and physical activity in reducing overweight and obesity. Then, the educational classes will include six weekly teaching units. The general objective is to prevent obesity among students by delivering education and behavioural skills. The training units will be carried out in the schools. Each training unit will end with activities. The adolescents will learn more about their susceptibility to obesity and weight gain and how to make better decisions and feel better about themselves through these activities.

Participants randomized to the control group in this study will not receive any intervention (They will have their regular curriculums and normal physical activity routine).

Outcomes

Primary Outcome Measures

Change Knowledge, Attitude and Practice of Nutrition and Physical Activity.
The Knowledge, Attitude, and Practice of Nutrition and Physical Activity will be measured using a self-report instrument Knowledge, Attitude, and Practice of Nutrition and Physical Activity Questionnaire (KAP-Q). The questionnaire consists of 73 items: knowledge (30), attitude (22), and practice (21). The presented knowledge part consists of 30 items to determine participants' knowledge level on Nutrition and Physical Activity. There are multiple-choice questions ell be each choice has "True", "False", and "I do not know" response options. Having a score above the mean means good knowledge. In the attitude section, there are 22 items with five Likert scales for assessing the attitude. A more positive attitude has higher scores. Practice includes 21 questions with five Likert scales for assessing the practice. A higher score shows more positive practice.
Change Physical Activity of the adolescent.
The Physical Activity will be measured using a self-report instrument Physical Activity Questionnaire for Older Children (PAQ-C). PAQ-C gives an overview of physical activity levels among participants of this study because PAQ-C is suitable for school children (8-14 years of age). PAQ-C has ten items. Each of the 9 PAQ-C questionnaire items is scored from 1 (low physical activity) to 5 (high physical activity), and a mean score of all items constitutes the overall PAQ-C score.

Secondary Outcome Measures

Change Sedentary Activity of the adolescent.
Sedentary Activity will be measured by using a self-report instrument the Adolescent Sedentary Activity Questionnaire (ASAQ). The questionnaire will ask the participants how many hours and minutes they spent in eleven different sedentary behaviours per day on weekdays and weekends. The questionnaire classified the eleven sedentary behaviours into five categories (Screen time, education, travel, cultural activities and social activities). Participants indicate high sedentary behaviour if the total time of (ASAQ) ≥ 4 hrs/day, while < 4 hrs/day means low sedentary behaviour.
Change frequency of consumption of food.
The frequency of consumption of food will be measured by using a self-report instrument Semi-Quantitative Food-Frequency Questionnaire (SFFQ). The SFFQ contains 74 food items among adolescents in the Arab region. The category of frequency intake is once per day, 2-3 per day, 4-5 per day, 6-7 times per day, 1-2 weeks, 3-4 per week, 5-6 per week, once a month, 2-3 monthly, or never. The 74 items of nutrients and food groups' reproducibility rates were 0.46 and 0.49, respectively. Participants will ask about the food that they consumed. Also, they will define the time and the quantity of the food.
Change Health Belief
The Health Belief will be measured by using a self-report instrument Health Belief Questionnaire (HBQ). There will be 89 statements total, representing 8 perceptional and behavioural categories including severity perception, perceived barriers, perceived benefits, action cues, dietary self-efficacy, exercise self-efficacy, and weight management behavioural intention. All statements were rated using a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). A higher score indicates a greater level of belief.
Change the Body mass index (BMI).
The Body mass index (BMI) will be report in kg/m^2 by using the following formula (BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared). Body weight will be measured using Omron HBF 375 to the nearest 0.1 kg. SECA body meter 206 will be employed to measure their heights to the nearest 0.1 cm. Body mass index (BMI) will be classified into (underweight, normal weight, overweight, and obesity). If the BMI is less than 18.5, it falls within the underweight range. If the BMI is 18.5 to <25, it falls within the healthy weight range. If the BMI is 25.0 to <30, it falls within the overweight range. If the BMI is 30.0 or higher, it falls within the obesity range. In addition, the Body mass index (BMI)-for-age (z-score) will be analysed using WHO AnthroPlus version 1.0.4 software and the WHO Growth Reference was used to categorise their body weight status using the reference data for children and adolescents aged 5-19 years.

Full Information

First Posted
January 9, 2023
Last Updated
January 19, 2023
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT05694143
Brief Title
the Effectiveness of Health Literacy Intervention Among Middle Eastern Adolescents in Malaysia
Official Title
The Effectiveness Of Health Literacy Intervention On Physical Activity And Healthy Diet Among Middle Eastern Adolescents In Malaysia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In Malaysia, Middle Eastern adolescents are going through changes in living status, yet few studies show that overweight and obesity are prevalent among Arabic secondary school students. There have not been any intervention studies among Middle Eastern adolescents in Malaysia. The current study aims to determine the effects of an intervention program on physical activity and healthy diet behavior among Middle Eastern adolescent students in Arabic schools in Malaysia
Detailed Description
A cluster randomized controlled study will be conducted among 250 Middle Eastern adolescent students in Arabic schools in Malaysia. The intervention and control schools will be selected and allocated randomly. The intervention group will have six weeks of fortnightly six sessions (45 minutes), while the control group will have their regular curriculums and normal physical activity routine. Anthropometric questionnaires include knowledge, attitude, and practice of lifestyle, physical activity, adolescent sedentary activity, food assessment, and health belief model questionnaire. Data will be collected from intervention and control groups at baseline, post-intervention, and tow month follow-up after the intervention. Data will be analyzed by using the (SPSS) software version 25. Descriptive statistics will be used to distribute and summarize the data. The normality of variables will be tested by The Kolmogorov-Smirnov test and the Skewness & Kurtosis test. A P-value < 0.05 will be considered statistically significant. One Way ANOVA will be used to determine whether any significant within group differences existed over time for the selected variables if the data is normally distributed, while Friedman's test will be used if the data is not normally distributed. Generalized Estimating Equation (GEE) will be used to test the effect of the intervention program for the selected variables (outcomes) between & within-group at baseline, six weeks, and one month after intervention which is adjusted for clustering

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescents Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A cluster randomized controlled trial design
Masking
Participant
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Other
Arm Description
Intervention group: Participants assigned to the intervention group will receive both will receive educational intervention including educational booklet will be distributed to the participants in the first session, and they will be asked to take it home and read it within one week. The booklet's content will include the risk factors of NCD and the benefits of adopting a healthy diet and physical activity in reducing overweight and obesity. Then, the educational classes will include six weekly teaching units. The general objective is to prevent obesity among students by delivering education and behavioural skills. The training units will be carried out in the schools. Each training unit will end with activities. The adolescents will learn more about their susceptibility to obesity and weight gain and how to make better decisions and feel better about themselves through these activities.
Arm Title
Control group: No Intervention
Arm Type
Other
Arm Description
Participants randomized to the control group in this study will not receive any intervention (They will have their regular curriculums and normal physical activity routine).
Intervention Type
Other
Intervention Name(s)
Education Intervention
Intervention Description
This intervention is based on the Health Belief Model Theory, which examines the attitudes and beliefs of adolescents with enhanced knowledge and perceived disease risk. As a result, It aims to build on adolescents' skills and behaviours rather than increase their knowledge, beliefs, and relative skills. In order to develop the education program, health promotion experts with a special interest in changing obesity-related behaviours will assist the researcher. The intervention is specifically designed to help adolescents: To know facts, statistics and harmful effects of obesity and overweight. To know facts about physical activity and its importance. To know facts about a healthy diet and its importance. Definition of BMI and calculating the BMI. To read the Nutrition Facts label. To develop decision-making and self-care education.
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
They will have their regular curriculums and normal physical activity routine
Primary Outcome Measure Information:
Title
Change Knowledge, Attitude and Practice of Nutrition and Physical Activity.
Description
The Knowledge, Attitude, and Practice of Nutrition and Physical Activity will be measured using a self-report instrument Knowledge, Attitude, and Practice of Nutrition and Physical Activity Questionnaire (KAP-Q). The questionnaire consists of 73 items: knowledge (30), attitude (22), and practice (21). The presented knowledge part consists of 30 items to determine participants' knowledge level on Nutrition and Physical Activity. There are multiple-choice questions ell be each choice has "True", "False", and "I do not know" response options. Having a score above the mean means good knowledge. In the attitude section, there are 22 items with five Likert scales for assessing the attitude. A more positive attitude has higher scores. Practice includes 21 questions with five Likert scales for assessing the practice. A higher score shows more positive practice.
Time Frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Title
Change Physical Activity of the adolescent.
Description
The Physical Activity will be measured using a self-report instrument Physical Activity Questionnaire for Older Children (PAQ-C). PAQ-C gives an overview of physical activity levels among participants of this study because PAQ-C is suitable for school children (8-14 years of age). PAQ-C has ten items. Each of the 9 PAQ-C questionnaire items is scored from 1 (low physical activity) to 5 (high physical activity), and a mean score of all items constitutes the overall PAQ-C score.
Time Frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Secondary Outcome Measure Information:
Title
Change Sedentary Activity of the adolescent.
Description
Sedentary Activity will be measured by using a self-report instrument the Adolescent Sedentary Activity Questionnaire (ASAQ). The questionnaire will ask the participants how many hours and minutes they spent in eleven different sedentary behaviours per day on weekdays and weekends. The questionnaire classified the eleven sedentary behaviours into five categories (Screen time, education, travel, cultural activities and social activities). Participants indicate high sedentary behaviour if the total time of (ASAQ) ≥ 4 hrs/day, while < 4 hrs/day means low sedentary behaviour.
Time Frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Title
Change frequency of consumption of food.
Description
The frequency of consumption of food will be measured by using a self-report instrument Semi-Quantitative Food-Frequency Questionnaire (SFFQ). The SFFQ contains 74 food items among adolescents in the Arab region. The category of frequency intake is once per day, 2-3 per day, 4-5 per day, 6-7 times per day, 1-2 weeks, 3-4 per week, 5-6 per week, once a month, 2-3 monthly, or never. The 74 items of nutrients and food groups' reproducibility rates were 0.46 and 0.49, respectively. Participants will ask about the food that they consumed. Also, they will define the time and the quantity of the food.
Time Frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Title
Change Health Belief
Description
The Health Belief will be measured by using a self-report instrument Health Belief Questionnaire (HBQ). There will be 89 statements total, representing 8 perceptional and behavioural categories including severity perception, perceived barriers, perceived benefits, action cues, dietary self-efficacy, exercise self-efficacy, and weight management behavioural intention. All statements were rated using a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). A higher score indicates a greater level of belief.
Time Frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Title
Change the Body mass index (BMI).
Description
The Body mass index (BMI) will be report in kg/m^2 by using the following formula (BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared). Body weight will be measured using Omron HBF 375 to the nearest 0.1 kg. SECA body meter 206 will be employed to measure their heights to the nearest 0.1 cm. Body mass index (BMI) will be classified into (underweight, normal weight, overweight, and obesity). If the BMI is less than 18.5, it falls within the underweight range. If the BMI is 18.5 to <25, it falls within the healthy weight range. If the BMI is 25.0 to <30, it falls within the overweight range. If the BMI is 30.0 or higher, it falls within the obesity range. In addition, the Body mass index (BMI)-for-age (z-score) will be analysed using WHO AnthroPlus version 1.0.4 software and the WHO Growth Reference was used to categorise their body weight status using the reference data for children and adolescents aged 5-19 years.
Time Frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Arabic citizen students Aged 13 to 14 years Who at least one of their parents consented to participate in the study. Exclusion Criteria: Students with diseases such as asthma, diabetes, cancer, cardiovascular diseases, fractures, cirrhosis, or other diseases. Students with any medical condition who are not allowed to do physical activity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanan Al-haroni
Phone
0172855427
Email
alharonihanan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nik Daliana NIK Farid
Phone
0060122779250
Email
daliana@ummc.edu.my
Facility Information:
Facility Name
Hanan Al-haroni
City
Kuala lumpur
State/Province
Selangor
ZIP/Postal Code
53300
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanan Al-haroni
Phone
0060172855427
Email
alharonihanan@gmail.com
First Name & Middle Initial & Last Name & Degree
Nik Daliana Nik Farid
Phone
0060122779250
Email
daliana@ummc.edu.my

12. IPD Sharing Statement

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the Effectiveness of Health Literacy Intervention Among Middle Eastern Adolescents in Malaysia

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