Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 28, 2022
Date Accepted: Nov 16, 2022
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An Experimental study protocol to design, develop and implement an internet-enabled informatics platform to enhance well-being among individuals aged 18-24 years Background Well-being is multidimensional, complex, and dynamic in nature. It is an amalgam of both physical and mental health which are essential for disease prevention and the promotion of healthy life. Objective This study aims to explore the factors that influence the well-being of individuals in the age group of 18-24 years in an Indian setting. The study further aims to design, develop and evaluate the usefulness and effectiveness of an Internet-based platform/standalone intervention to improve the well-being among individuals in the age group of 18-24 years in an India
ABSTRACT
Background:
Well-being is a combination of both physical and mental health which are important for disease prevention and the promotion of healthy life. It is complex and multidimensional. Well-being measures consist of objective and subjective measures. The objective measures indicate the standard of living while subjective measures comprise spiritual, social, psychological, affective, and cognitive judgments. Psychological well-being (PWB) refers to the psychological aspect and consists of hedonic well-being (e.g. feeling happy), evaluative well-being (e.g. contentment from life), and eudaimonic well-being (e.g. self-actualization, to know the meaning of life) and the other aspects of feeling well, optimism [1]. Mental health (MH) is described as a condition of well-being in which the person understands their own abilities, can manage the normal pressures of life, can work effectively and fruitfully, and can also contribute to the community [2]. (WHO 2004) As per Global Health Estimates 2016, the leading cause of non-fatal disease is mental and substance use disorders [3]. In the United States in 2017 more than 46.6 million adults were reported to have mental illness in the previous year [4]. In the world, in 2017 MH is the second main cause of disease burden in terms of years lived disability (YLDs) and the sixth main factor of disability-adjusted life-years (DALYs) which is a significant threat to health systems, especially on low income and middle-income countries. MH is considered a crucial factor around the world therefore it is included in health policies and in Sustainable Development Goals [5]. One-fourth of the entire World population is between 10-and 24 years. However, in South Asia and Africa, one in three people is a young person. Mental health problem ranges from 10% to 20% worldwide among children and young people (CYP) [6]. A study done in 27 countries assessed the global pooled MH problems prevalence to be 13.4% between children and young people [7]. Anxiety and disruptive behavior were commonly observed among children and young people. It is estimated that in young people aged 16 to 24 years 1 in 4 has experienced a minimum of one MH problem in the previous year. Literature has shown that young people worldwide are less aware of mental health. In young individuals to promote mental well-being, there is a need to educate, raise awareness, and come up with interventions [8]. As per the Registrar General of India, 34.8% of India’s population is between 15-and 34 years of age and is projected to be 34.1% by 2021. In India, The prevalence of mental disorders is 197.3 million which includes 45.7 million people with depressive disorder and 44.9 million with anxiety disorders in 2017 [9]. Due to an increase in issues like Nutritional disorders, phubbing, sedentary lifestyle, social media addiction, and substance abuse in developing countries. In rural India, a study has been done to find the effectiveness of delivering evidence-based psychological treatment for depression by training community health workers [10]. Research have demonstrated the usefulness and effectiveness of web-based interventions among youth and for mental health issue[8]. It is also seen that young people feel more comfortable gathering mental health information through the internet for such sensitive and personal issues. Studies recommend that there is a need to promote personalized Digital health intervention (DHI). The intervention should have the ability to engage individuals by sending personalized messages, reminders, or alerts to increase motivation. Research has also shown that technology acceptance and user engagement can be increased by using pictures and interactive content[11]. However, there is limited literature available on digital health interventions to improve well-being among youth in India.
Objective:
Following are the proposed study objectives: 1. To examine factors that influence the well-being of individuals in the age group of 18-24 years in an Indian setting. 2. To design and develop an Internet-based platform/standalone intervention to improve the well-being among individuals in the age group of 18-24 years in an Indian setting. 3. To evaluate the usefulness and effectiveness of the proposed informatics-enabled decision-aid platform to enhance well-being among individuals aged 18-24 years in an Indian setting.
Methods:
Study design and Population We will utilize mixed methods approach using a combination of both qualitative and quantitative data to identify factors influencing the well-being of individuals in the age group of 18-24 years in an Indian setting. In this study, 100 individuals will be enrolled in each intervention and control group from colleges in Uttarakhand and Uttar Pradesh. We will design and develop the proposed platform using principles of human-centered design. Individuals will be randomly assigned to an intervention group (access to the proposed well-being platform) and the control group (standard education). Study setting We will recruit college-going students aged 18-24 years from the state of Uttarakhand (Urban Dehradun) and Uttar Pradesh (Urban Meerut). Study eligibility The inclusion criteria will include: i) individuals ≥18-24 years of age, ii) both gender and iii) informed written consent. Subjects will be excluded if <18 years of age or above 24 years of age, are not willing to give consent, or with any disability or chronic diseases. This study will follow a mixed method with a pre and post-approach for data collection using electronic data collection tools for both qualitative and quantitative data from the study participants. To achieve objective 1: To examine factors that influence the well-being of individuals in the age group of 18-24 years in an Indian setting. We will conduct 120 in-depth interviews by enrolling participants across Dehradun and Meerut. Both quantitative and qualitative data will be gathered from these college-going students. The data gathered will help us to examine the factors attributing to the well-being of individuals in the age group of 18-24 years. Emphasis will also be to understand an individual’s prior knowledge, and attitude related to stress, unhealthy diet, and physical inactivity. Content analysis of the qualitative data will help to generate key themes on well-being among individuals in the age group of 18-24 years in an Indian setting. To achieve objective 2: To design and develop an Internet-based platform/standalone intervention to improve the well-being among individuals in the age group of 18-24 years in an Indian setting. We will employ principles of a human-centered approach to design and develop an internet-based informatics platform to improve the well-being of individuals in the age group of 18-24 years in an Indian setting. The usability of the internet-based informatics platform will be done by individuals who will use and provide system feedback. Literature has shown that the System Usability scale a 10-item Likert scale questionnaire looks at the ease of use of websites, software, hardware, mobile devices, and other technological applications. Based on the feedback from usability evaluation, system modification can be done. Finally, the proposed internet well-being platform will be implemented in a randomized controlled trial to evaluate its usefulness and effectiveness. To achieve objective3: To evaluate the usefulness and effectiveness of the proposed informatics-enabled decision-aid platform to enhance well-being among individuals aged 18-24 years in an Indian setting. We will perform a randomized controlled trial with 100 college-going students from each Dehradun and Meerut. The total number of students enrolled will be 200. In this students will be randomly assigned to a control or intervention group. Students in the intervention group will have the access to the internet-based well-being platform. The data collected on these variables will be done: Sociodemographics, Health behavior, Health literacy, Depression, stress, anxiety assessments, General efficacy, Physical activity, Dietary pattern at baseline and follow up at 6 months. Study groups The participants will be randomly assigned either to the intervention group or to the control group. Intervention The subjects in the intervention group will have access to the Internet-based well-being platform. The proposed platform will have the following components (a) Screening component, (b) Learning Component, and (c) Evaluation Component. Variables recorded in the screening component include; • Sociodemographics • Health behavior (e.g. Physical activity levels and anthropometric assessments) • Health Literacy • Family history • Familiarity with the use of technology • Well-being scale • Depression, stress, anxiety assessments • Self-efficacy levels Based on the data collected, a well-being index will be constructed to reflect on the variables attributing to the poor well-being of the youth. • Learning Component: Based on the well-being index generated for each individual, tailored messaging will be done using a series of culturally and contextually relevant messages. In this component, the individual will get personalized feedback after interpreting the information gathered on all the parameters asked. They will receive weekly reminder messages to follow the healthy behavior for their good well-being. • Evaluation component: We will assess the usefulness and acceptance of the system using the system usability scale and also monitor the usage of the system. In addition, we will assess youth well-being using the well-being scale at baseline and at month 6 of the follow-up. Informed Consent The ethics committee of the university has approved the informed consent form. The consent will be taken from all the individuals participating in the study by the research team. The research team will also explain to them the study, duration, and need of the study. Individuals who are willing to participate will be asked to sign the consent form and a copy of the consent form with study details will be given to them. As the study is on college-going students so everyone will be able to read and write. The research person will be aware of both English and Hindi languages so would be able to understand the response. The data captured will be stored safely and protected. The confidentiality of data will be maintained. The participants will be allowed to withdraw from the study anytime by giving the reason to withdraw. All the data gathered including from the participants who have withdrawn will be reported for final analysis. There will be no monetary compensation given to the participants enrolled in the study. The voluntary participation and time of the participants will be respected. Data Collection, Data Entry, and Quality Assurance Data will be collected and entered by following standard techniques and protocols. Complete confidentiality of the information obtained from the study participants will be ensured. All the data will be retained through frequent backups, and all computers and specific data files will be password protected and kept in a locked file cabinet. Variable Assessment Socio-demographic and Family history The questionnaire included questions regarding the demographic characteristics of the respondents such as age, gender, family history, educational status, occupation, and income levels. Health literacy Health literacy is defined as the ability to obtain, process, and understand basic information and services needed to make appropriate health decisions. Many aspects of health like health knowledge, health status, use of health facilities and cost is related to literacy levels by many studies. One of the most popular tests is the Rapid Estimate of Adult Literacy in Medicine (REALM). It tests the patient’s ability to pronounce 66 common medical words and lay terms for body parts and illnesses and can be administered in less than two minutes. The REALM is one of the oldest and most widely used health literacy assessment instruments. Scores can be collapsed into two groups as0–44=Low health literacy and 45–66=Higher health literacy. Familiarity with technology Individual assessment will include access to the type of cell phone, familiarity with the use of the internet and knowledge of texting, and use of social media. Anthropometric measurements Variables assessed include duration of diabetes, recent blood sugar report, and type of medication. Height and weight measurements will help calculate body mass index. Health behavior The four important behavioral risk factors such as tobacco consumption, harmful use of alcohol, and sleep duration will be collected. Well-being Scale Ryff’s scale is a 42-item scale that measures six aspects of wellbeing and happiness. Depression, Anxiety and Stress Scale (DASS) Depression Anxiety Stress Scales 21 is a short version of a 42-item self-report instrument designed to measure the three related negative emotional states of depression, anxiety, and tension/stress. This is a 21-item scale measured on a 4-point rating scale (0–3), “0” denoting “did not apply to me at all” and “3” denoting “applied to me very much, or most of the time.” Dietary diversity FANTA diet diversity score will be computed based on the information obtained regarding the consumption of several food items within each food group. General Self-Efficacy Scale It is built on ten items, developed for use in diverse cultures, has been validated in Asia[7], and is positively correlated with depression, anxiety, and optimism. To calculate the total score the sum of all items is considered. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy. Physical Activity assessment All participants will complete a validated, short form of the International Physical Activity Questionnaire (IPAQ) to calculate the total time spent in physical activity for recreation, occupation, household work, and transportation in the last 7 days. Total weekly physical activity (metabolic equivalents of task (MET-hr/wk) will be calculated as the weighted sum of the reported time spent at each intensity using a MET value specific to each category. Tools Mentioned in the table below will be administered. Data Tool Socio-demographic and family history Age, gender, educational status, religion, income if any, parents' occupation Health literacy REALM scale Familiarity with technology Access to cell phone, and internet and knowledge of texting Health behavior Information on smoking, alcohol, physical activity, and substance abuse disorders Well-being scale Ryff’s scale Depression, Stress, and Anxiety assessments DASS scale Self-efficacy General self-efficacy scale Dietary diversity FANTA Diet diversity Anthropometric measurements Height, weight, BMI Physical Activity Global Physical Activity Questionnaire System Usability System usability scale Data Security and Privacy The Security of the data will be maintained through regular backups, and all computers and specific data files will be password protected and kept in a locked file cabinet. The computers in which data is stored will be password protected and will be safely stored for 3 years after completion of the study. Outcomes The well-being index generated from this study can be used in other geographic regions for similar populations. If the youth of a nation is healthy then it will lead to the growth of the country. Data Analysis Plan The data gathered at baseline will include socio-demographics, KAP, diet assessment, physical activity, health literacy, social media, and familiarity with technology. Baseline and follow-up data will be statistically analyzed. For continuous variables means and SD while frequencies will be reported for categorical variables will be calculated. We will cross-tabulate the intervention group against outcome variables to assess the direction and degree of association in this initial stage. All analysis will be performed using SAS v9.1 and reporting of the results will be done at 95% CIs and P=.049. Project Timeline and Milestones Tasks Involved Timeline Focus Group Discussion and Analysis Month 1 Content Creation for the internet-based Platform Month 2 and 3 Design and development of Internet-based platform Month 3 and 4 Heuristic and Usability evaluation Month 5 and 6 Data Collection Month 6 and 12 Analysis of data Month 13 and 14 Thesis writing and manuscript preparation Month 14, 15, and 16. Ethics and Dissemination The study has received ethical approval from the University Research Ethics Committee (UREC) of DIT University, Dehradun, India (Protocol DITU/UREC/2021/07/9 dated 21st July 2021). The study results will be presented at conferences/ webinars for the dissemination of information to researchers. The results will also be published in national and international scientific journals.
Results:
This study will bring forward the factors that influence the well-being of the individuals among 18-24 years. It will also facilitate to design, and development of an Internet-based platform/standalone intervention to improve the well-being of individuals in the age group of 18-24 years in an Indian setting.
Conclusions:
The study will help to understand the factors that influence well-being among individuals in the age group of 18-24 years. It will also provide in-depth information to know the barriers and challenges among youth for well-being. As this is the most important segment of individuals if they are left untreated it will affect their productivity and will also harm their families and community. The findings of this study will support to design, and development of an Internet-based platform/standalone intervention to improve the well-being among individuals and evaluate the usefulness and effectiveness of the proposed informatics-enabled decision-aid platform to enhance well-being in the age group of 18-24 years in an Indian setting. The well-being index generated from this study can be used in other geographic regions for a similar population. If the youth of a nation is healthy then it will lead to the growth of the country. The study results will be presented at conferences/ webinars for the dissemination of information to researchers. The results will also be published in national and international scientific journals.
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