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

NCT ID: NCT05694143

Last Updated: 2023-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-10-31

Brief Summary

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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

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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

Conditions

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Adolescents Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

A cluster randomized controlled trial design
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

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.

Group Type OTHER

Education Intervention

Intervention Type OTHER

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.

Control group: No Intervention

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).

Group Type OTHER

No Intervention

Intervention Type OTHER

They will have their regular curriculums and normal physical activity routine

Interventions

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Education Intervention

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

No Intervention

They will have their regular curriculums and normal physical activity routine

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hanan Al-haroni

Kuala Lumpur, Selangor, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Hanan Al-haroni

Role: CONTACT

0172855427

Nik Daliana NIK Farid

Role: CONTACT

0060122779250

Facility Contacts

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Hanan Al-haroni

Role: primary

0060172855427

Nik Daliana Nik Farid

Role: backup

0060122779250

References

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Al-Haroni H, Nik Farid ND, Azanan MS. Effectiveness of education intervention, with regards to physical activity level and a healthy diet, among Middle Eastern adolescents in Malaysia: A study protocol for a randomized control trial, based on a health belief model. PLoS One. 2024 Jan 17;19(1):e0289937. doi: 10.1371/journal.pone.0289937. eCollection 2024.

Reference Type DERIVED
PMID: 38232100 (View on PubMed)

Other Identifiers

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UM-PhD Hanan

Identifier Type: -

Identifier Source: org_study_id

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