School-based e-Health Non-Communicable Disease (NCD) Prevention Program to Improve Awareness in Adolescents From Urban Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 272
- 试验地点
- 7
- 主要终点
- To assess feasibility (Recruitment rate) of the School-based eHealth NCD prevention program
研究概览
简要总结
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 :
- 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.
- 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.
- To assess the feasibility and effectiveness of the School-based eHealth NCD prevention program in secondary and higher secondary school in Karachi.
- 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.
- 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.
Researcher aim 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.
Participants of intervention group will attend 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 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 will be conducted in the classroom for the intervention group.
详细描述
A sequential mixed methods design is used to allow a more robust exploration, validation, and explanation of the complex factors surrounding the implementation and effectiveness of a school-based eHealth NCD prevention program for currently enrolled grade 9-12 students in Karachi. The project progresses from initial exploration (qualitative exploration phase) to validation (quantitative phase) and deeper understanding (qualitative explanation phase), enhancing the study's overall rigor and validity. The qualitative exploration phase is based on an adaptation of the Technology Acceptance Model (TAM) and Task Technology Fit Model (TTFM).
Before starting the study, permission is obtained from the pertinent authorities at the provincial and district education departments, as well as from school principals. Consent will be sought from parents, while assent will be obtained from secondary and higher secondary school students. Scheduling of data collection will be coordinated with school administrators to ensure a suitable time. Trained data collectors will be responsible for gathering data on the school premises using interview-based questionnaires.
QUALITATIVE EXPLORATORY PHASE By starting with the exploratory qualitative phase, the study aims to explore the perceptions of secondary and higher secondary school students regarding the usefulness, acceptability, and task technology fitness of a school-based eHealth NCD prevention program in improving the knowledge, attitudes, and practices. A total of four FGDs (two groups of students and two groups of teachers) with eight participants each and at least ten key informant interviews (five from school administrators and five from parents) will be conducted. Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines will be used to analyze all qualitative data. The data will be audio-recorded, compiled, translated into English, and then analyzed using manual thematic analysis and Qualitative Solutions and Research International (QSR) NVivo version 10 for thematic-content analysis. All interviews and FGDs will be transcribed in English. Commonalities and differences across the data will be identified and clustered around thematic sections. Verbatim quotes will be added to complement the themes. This initial phase will yield rich contextual insights that can inform the design and content of the program.
QUANTITATIVE PHASE - INTERVENTION The subsequent quantitative phase will build upon the findings from the qualitative exploration phase, allowing for the systematic assessment of the program's feasibility and effectiveness 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, using a clustered randomized controlled trial design. This sequential approach allows the researchers to utilize qualitative insights to inform the development of the quantitative phase, ensuring that the research process is informed and responsive to the complexities of the research context. The quantitative phase will then assess the feasibility and effectiveness of the intervention, validating and extending the qualitative findings.
With a desired statistical power of 0.8 and a confidence interval of 0.05, coupled with an anticipated effect size of 25%, the calculated sample size was found to be 247 participants. To account for potential attrition, a prudent approach involves adding a 10% attrition rate, resulting in a revised total sample size of 272 (136 individuals will be allocated to the intervention group and another 136 to the control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Phase 1 (FGDs and Interviews)
- •Students currently enrolled in secondary and higher secondary schools in Karachi and are in grades 9 to
- •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)
排除标准
- •Schools outside Karachi
结局指标
主要结局
To assess feasibility (Recruitment rate) of the School-based eHealth NCD prevention program
时间窗: 2 months
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%
To assess feasibility (Retention Rate) of the School-based eHealth NCD prevention program
时间窗: 3 months
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%
To assess feasibility (treatment fidelity) of the School-based eHealth NCD prevention program
时间窗: 2 months
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.
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.
时间窗: 2 months
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.
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.
时间窗: 2 months
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.
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.
时间窗: 2 months
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.
次要结局
未报告次要终点
研究者
Dr Tazeen Saeed Ali
Professor
Aga Khan University