Clinical trial NCT05694143: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescents Obesity
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 250
Sex: ALL
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A cluster randomized controlled trial design
Primary purpose: OTHER

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

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.

Primary outcomes:
measure: Change Knowledge, Attitude and Practice of Nutrition and Physical Activity.
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
measure: Change Physical Activity of the adolescent.
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Secondary outcomes:
measure: Change Sedentary Activity of the adolescent.
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
measure: Change frequency of consumption of food.
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
measure: Change Health Belief
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
measure: Change the Body mass index (BMI).
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Other outcomes:
Locations:
city: Kuala lumpur
country: Malaysia
facility: Hanan Al-haroni
state: Selangor
Study officials:
References: