School-based e-Health Non-Communicable Disease (NCD) Prevention Program

NCT06674798 | Recruiting

• 1 other identifier: 2023-9277-27367
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 7

Brief Summary

The goal of this sequential mixed method study is to assess the feasibility and effectiveness of a school-based eHealth-NCD prevention program intervention to improve adolescents' knowledge, attitude, and practices regarding NCDs and associated risk factors. It aims :

1. 1.To identify barriers and facilitators associated with implementing a school-based eHealth intervention to improve the knowledge, attitudes, and practices of secondary and higher secondary school students in Pakistan regarding NCDs and their associated risk factors.
2. 2.To explore the stakeholders' perceptions regarding the design and content of the School based eHealth NCD prevention Program to improve the knowledge, attitudes, and practices of secondary and higher secondary school students in Pakistan regarding NCDs and their associated risk factors.
3. 3.To assess the feasibility and effectiveness of the School-based eHealth NCD prevention program in secondary and higher secondary school in Karachi.
4. 4.To evaluate the effectiveness of the school-based eHealth NCD prevention program in significantly improving the knowledge, attitudes, and practices of secondary and higher secondary school students in Karachi, Pakistan, regarding NCDs and their associated risk factors, as compared to a control group not receiving the intervention.
5. 5.To explore the perceptions of students regarding the usefulness acceptability and task technology fit of the School-based eHealth NCD prevention Program in improving the knowledge, attitude, and practices of Pakistani Higher Secondary School students regarding NCDs and their associated risk factors.

Conditions

Noncommunicable Diseases; Health Knowledge, Attitudes, Practice; Non-communicable Disease Risk Factors

Outcome Measures

Primary Outcomes (6)

• To assess feasibility (Recruitment rate) of the School-based eHealth NCD prevention program

  Measurement Tool: Percentage of participants enrolled out of the total number invited. Units of Measure: Percentage (%). Description: It will be measured as the percentage of participants enrolled out of the total number of invited participants at baseline phase. The trial will be considered feasible if recruitment rates exceed 70%

  2 months

• To assess feasibility (Retention Rate) of the School-based eHealth NCD prevention program

  Measurement Tool: Percentage of retained participants at 3 months among those initially recruited. Units of Measure: Percentage (%). Description: The retention rate will measure the percentage of participants who remain available for follow-up assessments at 3 months among those recruited initially. The trial will be considered feasible if retention rates exceed 70%

  3 months

• To assess feasibility (treatment fidelity) of the School-based eHealth NCD prevention program

  Measurement Tool: Proportion of successfully conducted health-promoting sessions compared to planned sessions. Units of Measure: Proportion. Description: Treatment fidelity will be assessed as the proportion of health-promoting sessions that are successfully delivered as planned within the intervention period. A treatment fidelity rate above 70% will be used as a threshold for determining the program's feasibility in maintaining session integrity.

  2 months

• To assess effectiveness of the School-based eHealth NCD prevention program in improving the knowledge among secondary and higher secondary school students regarding the NCDs and their associated risk factors.

  Measurement Tool: Knowledge will be assessed using a set of 26 questions adapted from study "An intervention program to reduce non-communicable diseases related behavioral risk factors among adolescents in institutional settings of Bangladesh". Units of Measure: Percentage score Description: Each question will be scored as either correct or incorrect, on the basis of standard medical textbooks and guidelines. The total knowledge score will be calculated, with a higher score indicating a better Knowledge. Based on previous Knowledge, Attitudes, and Practices (KAP) studies where a score of 60% or above has been used to categorize participants as having a satisfactory level of knowledge. This means that participants who achieve a score equal to or above 60% on the knowledge assessment will be considered to have a satisfactory level of knowledge regarding NCDs and their associated risk factors.

  2 months

• To assess effectiveness of the School-based eHealth NCD prevention program in improving the attitude among secondary and higher secondary school students regarding the NCDs and their associated risk factors.

  Measurement Tool: A 14-item attitude questionnaire using a Likert scale adapted from study "An intervention program to reduce non-communicable diseases related behavioral risk factors among adolescents in institutional settings of Bangladesh".. Units of Measure: Total score of likert scale Description: Participants will be asked to rate each item on a 3-point scale, except for one item which will be rated on a 4-point scale. The scores will be added, and higher scores in the attitude section will indicate a more positive attitude towards NCDs' prevention. The attitude section will have a possible minimum score of 16 points and a possible maximum score of 49 points. In accordance with previous studies, the cut-off value for attitude will be set at 60%. This threshold is derived from existing research where a score of 60% or higher has been identified as an indicator of a positive or favorable attitude.

  2 months

• To assess effectiveness of the School-based eHealth NCD prevention program in improving the practices of secondary and higher secondary school students regarding the NCDs and their associated risk factors.

  Measurement Tool: 22 questions will measure the dietary habits, physical activity, smoking, and substance abuse practices based on World Health Organization (WHO) recommendations and standard practices adapted from study "An intervention program to reduce non-communicable diseases related behavioral risk factors among adolescents in institutional settings of Bangladesh". 1. Dietary risk behavior: presence of at least 2 of the 4 habits i.Inadequate fruit consumption: Less than 5 servings per day ii.Inadequate vegetable consumption: Less than 5 servings per day iii. Extra or raw salt consumption salt during every meal iv. Consuming Sugar Sweetened Beverage more than 3 days per week 2. Physical Inactive: less than 60 min of physical activity of moderate intensity per day 3. Smoking regularly in the last 30 days or exposed to passive smoking more than 3 days per week or any amount of alcohol intake or any substance abuse in the last 30 days will be regarded as at risk.

  2 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

In the intervention group, students will participate in 6 health promoting video sessions and three sessions will be delivered by trained facilitators per month. The session will be 30 to 40 minutes and the intervention will be provided over two months. The video material will be focused on the leading risk factors associated with NCDs as reported by different studies such as physical inactivity, unhealthy diet and overweight, obesity, harmful alcohol consumption and tobacco use.

Other: School-based eHealth NCD Prevention Program

Control Group

NO INTERVENTION

The control group will not receive any intervention, and the end-line assessment will be conducted after two months of the intervention from both the groups. However, to maintain ethical standards, one session regarding NCDs and their associated risk factors will be delivered by trained facilitators to the control group after the end-line assessment.

Interventions

School-based eHealth NCD Prevention Program OTHER

Students will participate in health-promoting sessions delivered by trained facilitators, with each session lasting 30 to 40 minutes. There will be a total of six health-promoting sessions conducted in the classroom for the intervention group, spanning two months with three sessions per month. The health-promoting videos from the school-based eHealth NCD prevention program will be shown in the classroom using multimedia. The drama-based videos will be developed in Urdu Language with English subtitles and will be based on based on contextually relevant content for the Pakistani secondary and higher secondary school students of age 13 to 18 years old. The content of these six sessions will be focused on the leading risk factors associated with NCDs as reported by different studies such as physical inactivity, unhealthy diet and overweight, obesity, harmful alcohol consumption and tobacco use.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase 1 (FGDs and Interviews)
• Students currently enrolled in secondary and higher secondary schools in Karachi and are in grades 9 to 12.
• Teachers who have been employed in secondary and higher secondary schools in Karachi for a minimum duration of 6 months.
• Parents or legal guardians of students who are currently enrolled in secondary and higher secondary schools in Karachi.
• Principals and vice principals of secondary and higher secondary schools in Karachi, District Education Officers, and decision-makers at Provincial Department of Education.
• Phase 2 (Intervention)
• \- Both study and control group would be selected from secondary schools (students in grades 9-10) and Higher Secondary Schools (students in grades 11-12) located in Karachi, Pakistan
• Phase 3 (FGDs) - Participants from grades 9 to 12 of the secondary and higher secondary schools who actively participated in the intervention and attended all the health-promoting sessions (equal representation of male and female)

You may not qualify if:

• \- Schools outside Karachi

Sponsors & Collaborators

• Aga Khan University: lead
• Fogarty International Center of the National Institutes of Health: collaborator

Study Sites (7)

Allama Iqbal G.B.H.S.S FB Area

Karachi, Sindh, Pakistan

RECRUITING

APWA G.G.H.S Liaquatabad

Karachi, Sindh, Pakistan

RECRUITING

EAB G.G.S.S Block 6

Karachi, Sindh, Pakistan

RECRUITING

G.B.H.S.S Farabi Muslimabad

Karachi, Sindh, Pakistan

RECRUITING

G.G.H.S.S Gulshan e Iqbal Block 6

Karachi, Sindh, Pakistan

RECRUITING

Junior Model School

Karachi, Sindh, Pakistan

RECRUITING

Major Ziauddin School

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Noncommunicable Diseases; Behavior

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Tazeen Saeed Ali, Ph.D

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Shahid Khan, Ph.D

CONTACT

+923000980102; shahid.khurshid@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Qualitative exploratory phase -quantitative intervention phase -qualitative explanatory phase

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: November 5, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

PA (7)