NCT05694143

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 9, 2023

Last Update Submit

January 19, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]

  • 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.

    [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]

Secondary Outcomes (4)

  • Change Sedentary Activity of the adolescent.

    [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]

  • Change frequency of consumption of food.

    [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]

  • Change Health Belief

    [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]

  • Change the Body mass index (BMI).

    [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]

Study Arms (2)

Intervention group

OTHER

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.

Other: Education Intervention

Control group: No Intervention

OTHER

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).

Other: No Intervention

Interventions

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 group

They will have their regular curriculums and normal physical activity routine

Control group: No Intervention

Eligibility Criteria

Age13 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Arabic citizen students
  • Aged 13 to 14 years
  • Who at least one of their parents consented to participate in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanan Al-haroni

Kuala Lumpur, Selangor, 53300, Malaysia

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Central Study Contacts

Hanan Al-haroni

CONTACT

Nik Daliana NIK Farid

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: A cluster randomized controlled trial design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 23, 2023

Study Start

January 1, 2023

Primary Completion

May 1, 2023

Study Completion

October 1, 2024

Last Updated

January 23, 2023

Record last verified: 2023-01

Locations