OBJECTIVE: The aim of this study is to determine the prevalence of antibiotic-resistant pathogenic bacteria and the level of antibiotic residues in the hospital effluents in Selangor, Malaysia.
METHODS: A cross-sectional study will be performed in the state of Selangor, Malaysia. Tertiary hospitals will be identified based on the inclusion and exclusion criteria. The methods are divided into three phases: sample collection, microbiological analysis, and chemical analysis. Microbiological analyses will include the isolation of bacteria from hospital effluents by culturing on selective media. Antibiotic sensitivity testing will be performed on the isolated bacteria against ceftriaxone, ciprofloxacin, meropenem, vancomycin, colistin, and piperacillin/tazobactam. The identification of bacteria will be confirmed using 16S RNA polymerase chain reaction (PCR) and multiplex PCR will be performed to detect resistance genes (ermB, mecA, blaNDM-L, blaCTX-M, blaOXA-48, blaSHV, VanA, VanB, VanC1, mcr-1, mcr-2, mcr-3, Intl1, Intl2, and qnrA). Finally, the level of antibiotic residues will be measured using ultrahigh-performance liquid chromatography.
RESULTS: The expected outcomes will be the prevalence of antibiotic-resistant Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter (ESKAPE) bacterial species from the hospital effluents, the occurrence of antibiotic resistance genes (ARGs) from the isolated ESKAPE bacteria, and the level of antibiotic residues that may be detected from the effluent. Sampling has been conducted in three hospitals. Data analysis from one hospital showed that as of July 2022, 80% (8/10) of E. faecium isolates were resistant to vancomycin and 10% (1/10) were resistant to ciprofloxacin. Further analysis will be conducted to determine if the isolates harbor any ARGs and effluent samples are being analyzed to detect antibiotic residues. Sampling activities will be resumed after being suspended due to the COVID-19 pandemic and are scheduled to end by December 2022.
CONCLUSIONS: This study will provide the first baseline information to elucidate the current status of AMR of highly pathogenic bacteria present in hospital effluents in Malaysia.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39022.
OBJECTIVE: This paper presents the protocol for a systematic review that aims to provide evidence of the impact of heat waves on health care services in LMICs.
METHODS: We will identify peer-reviewed studies from 3 online databases, including the Web of Science, PubMed, and SCOPUS, published from January 2002 to April 2023, using the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines. Quality assessment will be conducted using the Navigation Guide checklist. Key search terms include heatwaves, extreme heat, hospitalization, outpatient visit, burden, health services, and morbidity.
RESULTS: This systematic review will provide insight into the impact of heat waves on health care services in LMICs, especially on emergency department visits, ambulance call-outs, hospital admissions, outpatient department visits, in-hospital mortality, and health care operational costs.
CONCLUSIONS: The results of this review are anticipated to help policymakers and key stakeholders obtain a better understanding of the impact of heat waves on health care services and prioritize investments to mitigate the effects of heat waves in LMICs. This entails creating a comprehensive heat wave plan and ensuring that adequate infrastructure, capacity, and human resources are allocated in the health care sector. These measures will undoubtedly contribute to the development of resilience in health care systems and hence protect the health and well-being of individuals and communities.
TRIAL REGISTRATION: PROSPERO CRD42022365471; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=365471.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44702.
OBJECTIVE: This study aims to examine the association between the spatio-temporal distribution of leptospirosis hotspot areas from 2011 to 2019 with the hydroclimatic factors in Selangor using the geographical information system and remote sensing techniques to develop a leptospirosis hotspot predictive model.
METHODS: This will be an ecological cross-sectional study with geographical information system and remote sensing mapping and analysis concerning leptospirosis using secondary data. Leptospirosis cases in Selangor from January 2011 to December 2019 shall be obtained from the Selangor State Health Department. Laboratory-confirmed cases with data on the possible source of infection would be identified and georeferenced according to their longitude and latitudes. Topographic data consisting of subdistrict boundaries and the distribution of rivers in Selangor will be obtained from the Department of Survey and Mapping. The ArcGIS Pro software will be used to evaluate the clustering of the cases and mapped using the Getis-Ord Gi* tool. The satellite images for rainfall and land surface temperature will be acquired from the Giovanni National Aeronautics and Space Administration EarthData website and processed to obtain the average monthly values in millimeters and degrees Celsius. Meanwhile, the average monthly river hydrometric levels will be obtained from the Department of Drainage and Irrigation. Data are then inputted as thematic layers and in the ArcGIS software for further analysis. The artificial neural network analysis in artificial intelligence Phyton software will then be used to obtain the leptospirosis hotspot predictive model.
RESULTS: This research was funded as of November 2022. Data collection, processing, and analysis commenced in December 2022, and the results of the study are expected to be published by the end of 2024. The leptospirosis distribution and clusters may be significantly associated with the hydroclimatic factors of rainfall, land surface temperature, and the river hydrometric level.
CONCLUSIONS: This study will explore the associations of leptospirosis hotspot areas with the hydroclimatic factors in Selangor and subsequently the development of a leptospirosis predictive model. The constructed predictive model could potentially be used to design and enhance public health initiatives for disease prevention.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/43712.
OBJECTIVE: The aim of this study is to systematically review and carry out a meta-analysis of evidence on the outcome of early food introduction for preventing childhood allergic diseases.
METHODS: We will conduct a systematic review of interventions through a comprehensive search of various databases including PubMed, Embase, Scopus, CENTRAL, PsycINFO, CINAHL, and Google Scholar to identify potential studies. The search will be performed for any eligible articles from the earliest published articles up to the latest available studies in 2023. We will include randomized controlled trials (RCTs), cluster RCTs, non-RCTs, and other observational studies that assess the effect of early food introduction to prevent childhood allergic diseases.
RESULTS: Primary outcomes will include measures related to the effect of childhood allergic diseases (ie, asthma, allergic rhinitis, eczema, and food allergy). PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines will be followed for study selection. All data will be extracted using a standardized data extraction form and the quality of the studies will be assessed using the Cochrane Risk of Bias tool. A summary of findings table will be generated for the following outcomes: (1) total number of allergic diseases, (2) rate of sensitization, (3) total number of adverse events, (4) improvement of health-related quality of life, and (5) all-cause mortality. Descriptive and meta-analyses will be performed using a random-effects model in Review Manager (Cochrane). Heterogeneity among selected studies will be assessed using the I2 statistic and explored through meta-regression and subgroup analyses. Data collection is expected to start in June 2023.
CONCLUSIONS: The results acquired from this study will contribute to the existing literature and harmonize recommendations for infant feeding with regard to the prevention of childhood allergic diseases.
TRIAL REGISTRATION: PROSPERO CRD42021256776; https://tinyurl.com/4j272y8a.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46816.
OBJECTIVE: The objectives of this study are as follows: (1) to assess advance care planning among older people and their perception of life and health, end of life, and end-of-life care; (2) to explore older people's accessibility and receptiveness toward counseling; (3) elucidate older people's perspectives on counseling and its impact on emotional management and decision-making; (4) to assess older people's competencies in emotional management; and (5) to propose an intervention model for enhancing older people's well-being and dignity through psychological counseling in Singapore.
METHODS: A mixed method study design involving quantitative and qualitative methods will be used. Older individuals receiving some form of preventive, primary, or long-term care in the community through voluntary welfare organizations from the senior activity centers located in eastern Singapore participated in the qualitative phase. Six older individuals from each senior activity center have been enrolled for the interview phase to explore 6 components: the Advanced Care Planning (ACP) booklet, Trait Meta Mood Scale (TMMS), accessibility and receptiveness toward counseling, and emotional management and decision-making. The ACP, an instrument designed to assess advanced care planning among older individuals, and the TMMS, an instrument developed to measure meta-mood experience and emotional management, were used in the quantitative phase among 100 participants. The data will be analyzed thematically using NVivo version 12, whereas descriptive statistics and a 2-tailed, 1-sample t test will be conducted in SPSS (version 25; IBM Corp) for empirical data analyses.
RESULTS: The qualitative phase, which involves a semistructured interview, has been completed among 20 older individuals aged 66-86 years. Thematic analysis of the data is still ongoing. Meanwhile, the quantitative phase commenced on March 22, 2022, with 100 participants providing signed informed consent to participate in the study. The study is expected to be completed by March 2023.
CONCLUSIONS: The mixed methods study will document the current awareness of ACP, accessibility and receptiveness toward counseling, and the potential use of psychological counseling in enhancing well-being and dignity among older people in Singapore. The research findings will benefit policy makers in their decision-making when attempting to mitigate the potential barriers to seeking counseling assistance among older people.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45557.
OBJECTIVE: This study aims to evaluate the performance of Putralytica and Qure.ai software for CXR screening and PTB diagnosis among the Malaysian population.
METHODS: We will conduct a retrospective case-control study at the Respiratory Medicine Institute, National Cancer Institute, and Sungai Buloh Health Clinic. A total of 1500 CXR images of patients who completed treatments or check-ups will be selected and categorized into three groups: (1) abnormal PTB cases, (2) abnormal non-PTB cases, and (3) normal cases. These CXR images, along with their clinical findings, will be the reference standard in this study. All patient data, including sociodemographic characteristics and clinical history, will be collected prior to screening via Putralytica and Qure.ai software and readers' interpretation, which are the index tests for this study. Interpretation from all 3 index tests will be compared with the reference standard, and significant statistical analysis will be computed.
RESULTS: Data collection is expected to commence in August 2023. It is anticipated that 1 year will be needed to conduct the study.
CONCLUSIONS: This study will measure the accuracy of Putralytica and Qure.ai software and whether their findings will concur with readers' interpretation and the reference standard, thus providing evidence toward the effectiveness of implementing AI in the medical setting.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/36121.
OBJECTIVE: The aim of this study is to compare the accuracy, acceptability, and cost-effectiveness of 3 technology-assisted 24-hour dietary recall (24HR) methods relative to observed intake across 3 meals.
METHODS: Using a controlled feeding study design, 24HR data collected using 3 methods will be obtained for comparison with observed intake. A total of 150 healthy adults, aged 18 to 70 years, will be recruited and will complete web-based demographic and psychosocial questionnaires and cognitive tests. Participants will attend a university study center on 3 separate days to consume breakfast, lunch, and dinner, with unobtrusive documentation of the foods and beverages consumed and their amounts. Following each feeding day, participants will complete a 24HR process using 1 of 3 methods: the Automated Self-Administered Dietary Assessment Tool, Intake24, or the Image-Assisted mobile Food Record 24-Hour Recall. The sequence of the 3 methods will be randomized, with each participant exposed to each method approximately 1 week apart. Acceptability and the preferred 24HR method will be assessed using a questionnaire. Estimates of energy, nutrient, and food group intake and portion sizes from each 24HR method will be compared with the observed intake for each day. Linear mixed models will be used, with 24HR method and method order as fixed effects, to assess differences in the 24HR methods. Reporting bias will be assessed by examining the ratios of reported 24HR intake to observed intake. Food and beverage omission and intrusion rates will be calculated, and differences by 24HR method will be assessed using chi-square tests. Psychosocial, demographic, and cognitive factors associated with energy misestimation will be evaluated using chi-square tests and multivariable logistic regression. The financial costs, time costs, and cost-effectiveness of each 24HR method will be assessed and compared using repeated measures analysis of variance tests.
RESULTS: Participant recruitment commenced in March 2021 and is planned to be completed by the end of 2021.
CONCLUSIONS: This protocol outlines the methodology of a study that will evaluate the accuracy, acceptability, and cost-effectiveness of 3 technology-enabled dietary assessment methods. This will inform the selection of dietary assessment methods in future studies on nutrition surveillance and epidemiology.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621000209897; https://tinyurl.com/2p9fpf2s.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32891.
OBJECTIVE: We aim to review the available retention strategies for medical doctors in LMICs and to determine the effectiveness of the various strategies. This review aims to compile relevant research findings on this issue to generate a thorough summary of all the retention strategies practiced in LMICs and, more importantly, to provide the current state of evidence of the effectiveness of these strategies in retaining medical doctors in countries with limited resources and high disease burden.
METHODS: The structured framework given by Arksey and O'Malley will serve as the basis for conducting this scoping review. A comprehensive search strategy will be conducted across 4 electronic databases (PubMed, EBSCOHost, Scopus, and ScienceDirect). A systematic approach following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines will be executed to search, screen, review, and extract data from studies that meet predefined inclusion criteria. Data encompassing bibliographical information, study location, retention strategies, influencing factors, and outcomes (effectiveness) will be obtained from the selected studies using standardized data extraction. Endnote and Microsoft Excel will be used for reference management and removal of duplicate studies. A narrative synthesis will be performed after categorizing and analyzing all the extracted data to identify recurrent themes.
RESULTS: This ongoing review will generate a comprehensive compilation of retention strategies implemented in LMICs to prevent brain drain among medical doctors. Data extraction is currently in progress, and completion is expected by early 2024. Themes regarding the types of strategies, influencing factors, and outcomes will be synthesized. The findings will highlight effective retention strategies, gaps, and challenges in implementation for the benefits of future research. By identifying common barriers and facilitators, this review will provide insights into enhancing the policies and initiatives for doctor retention in LMICs.
CONCLUSIONS: This scoping review explores the retention strategies practiced in LMICs and attempts to identify effective strategies from existing research. By evaluating the barriers and challenges that influence the effectiveness of these strategies, policymakers and health care leaders can strive to obtain balanced and optimal health human resources in their respective organizations and countries.
TRIAL REGISTRATION: Malaysian National Medical Research Register (NMRR) ID-23-01994-OGW; https://nmrr.gov.my/research-directory/ac4f5b88-8619-4b2b-b6c7-9abcef65fdcd.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52938.
OBJECTIVE: We aimed to understand the current digital landscape and enabling environment around respiratory health to reduce costs, avoid duplication, and understand the comprehensiveness of DHIs.
METHODS: This study will follow a scoping review methodology as outlined by Arksey and O'Malley, the Joanna Briggs Institute, and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library, Web of Science, PakiMedNet, and MyMedR databases will be searched along with key websites, repositories, and gray literature databases. The terms "respiratory health," "digital health," "South Asia," and "Southeast Asia," as well as related terms will be searched. The results will be screened for duplicates and then against the inclusion and exclusion criteria. For the studies included, data will be extracted, collated, and analyzed.
RESULTS: The scoping review was started in July 2023 and will be finalized by February 2024. Results will be presented following the World Health Organization's classification of DHIs to categorize interventions in a standardized format and the mobile health evidence reporting and assessment checklist to report on the effectiveness of interventions. Further exposition of the evidence extracted will be presented through narrative synthesis.
CONCLUSIONS: As DHIs continue to proliferate, the need to understand the current landscape becomes more pertinent. In this scoping review, we will seek to more clearly understand what digital health tools and technologies are being used in the current landscape of digital health in South and Southeast Asia for respiratory health and to what extent they are addressing the respiratory health needs of the region. The results will inform recommendations on digital health tools for respiratory health in South and Southeast Asia will help funders and implementers of DHIs leverage existing technologies and accelerate innovations that address documented gaps in the studied countries.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52517.
OBJECTIVE: This paper presents a protocol of a bibliometric analysis aimed at offering the public insights into the current state and emerging trends in research related to the use of chatbot technology for promoting health.
METHODS: In this bibliometric analysis, we will select published papers from the databases of CINAHL, IEEE Xplore, PubMed, Scopus, and Web of Science that pertain to chatbot technology and its applications in health care. Our search strategy includes keywords such as "chatbot," "virtual agent," "virtual assistant," "conversational agent," "conversational AI," "interactive agent," "health," and "healthcare." Five researchers who are AI engineers and clinicians will independently review the titles and abstracts of selected papers to determine their eligibility for a full-text review. The corresponding author (ZN) will serve as a mediator to address any discrepancies and disputes among the 5 reviewers. Our analysis will encompass various publication patterns of chatbot research, including the number of annual publications, their geographic or institutional distribution, and the number of annual grants supporting chatbot research, and further summarize the methodologies used in the development of health-related chatbots, along with their features and applications in health care settings. Software tool VOSViewer (version 1.6.19; Leiden University) will be used to construct and visualize bibliometric networks.
RESULTS: The preparation for the bibliometric analysis began on December 3, 2021, when the research team started the process of familiarizing themselves with the software tools that may be used in this analysis, VOSViewer and CiteSpace, during which they consulted 3 librarians at the Yale University regarding search terms and tentative results. Tentative searches on the aforementioned databases yielded a total of 2340 papers. The official search phase started on July 27, 2023. Our goal is to complete the screening of papers and the analysis by February 15, 2024.
CONCLUSIONS: Artificial intelligence chatbots, such as ChatGPT (OpenAI Inc), have sparked numerous discussions within the health care industry regarding their impact on human health. Chatbot technology holds substantial promise for advancing health care systems worldwide. However, developing a sophisticated chatbot capable of precise interaction with health care consumers, delivering personalized care, and providing accurate health-related information and knowledge remain considerable challenges. This bibliometric analysis seeks to fill the knowledge gap in the existing literature on health-related chatbots, entailing their applications, the software used in their development, and their preferred functionalities among users.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54349.
OBJECTIVE: This study aims to (1) compare the detection rate of genetically confirmed FH and diagnostic accuracy between the FAMCAT, SB, and DLCC in the Malaysian primary care setting; (2) identify the genetic mutation profiles, including novel variants, in individuals with suspected FH in primary care; (3) explore the experience, concern, and expectation of individuals with suspected FH who have undergone genetic testing in primary care; and (4) evaluate the clinical utility of a web-based FH Identification Tool that includes the FAMCAT, SB, and DLCC in the Malaysian primary care setting.
METHODS: This is a mixed methods evaluation study conducted in 11 Ministry of Health primary care clinics located at the central administrative region of Malaysia. In Work stream 1, the diagnostic accuracy study design is used to compare the detection rate and diagnostic accuracy of the FAMCAT, SB, and DLCC against molecular diagnosis as the gold standard. In Work stream 2, the targeted next-generation sequencing of the 4 FHCGs is used to identify the genetic mutation profiles among individuals with suspected FH. In Work stream 3a, a qualitative semistructured interview methodology is used to explore the experience, concern, and expectation of individuals with suspected FH who have undergone genetic testing. Lastly, in Work stream 3b, a qualitative real-time observation of primary care physicians using the "think-aloud" methodology is applied to evaluate the clinical utility of a web-based FH Identification Tool.
RESULTS: The recruitment for Work stream 1, and blood sampling and genetic analysis for Work stream 2 were completed in February 2023. Data collection for Work stream 3 was completed in March 2023. Data analysis for Work streams 1, 2, 3a, and 3b is projected to be completed by June 2023, with the results of this study anticipated to be published by December 2023.
CONCLUSIONS: This study will provide evidence on which clinical diagnostic criterion is the best to detect FH in the Malaysian primary care setting. The full spectrum of genetic mutations in the FHCGs including novel pathogenic variants will be identified. Patients' perspectives while undergoing genetic testing and the primary care physicians experience in utilizing the web-based tool will be established. These findings will have tremendous impact on the management of patients with FH in primary care and subsequently reduce their risk of premature coronary artery disease.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47911.
OBJECTIVE: This study aims to assess the effectiveness of BIFI in reducing emotional distress and burden of care, fulfilling the needs, and increasing the life satisfaction of caregivers of patients with TBI at government hospitals in Malaysia.
METHODS: This is a 2-arm, single-blinded, randomized controlled trial. It will be conducted at Hospital Rehabilitasi Cheras and Hospital Sungai Buloh. In total, 100 caregivers of patients with TBI attending the neurorehabilitation unit will be randomized equally to the intervention and control groups. The intervention group will undergo the BIFI program, whereas the control group will receive standard treatment. Caregivers aged ≥18 years, caring for patients who have completed >3 months after the injury, are eligible to participate. The BIFI program will be scheduled for 5 sessions as recommended by the developer of the module. Each session will take approximately 90 to 120 minutes. The participants are required to attend all 5 sessions. A total of 5 weeks is needed for each group to complete the program. Self-reported questionnaires (ie, Beck Depression Inventory, Positive and Negative Affect Schedule, Caregiver Strain Index, Satisfaction With Life Scale, and Family Needs Questionnaire) will be collected at baseline, immediately after the intervention program, at 3-month follow-up, and at 6-month follow-up. The primary end point is the caregivers' emotional distress.
RESULTS: The participant recruitment process began in January 2019 and was completed in December 2020. In total, 100 participants were enrolled in this study, of whom 70 (70%) caregivers are women and 30 (30%) are men. We are currently at the final stage of data analysis. The results of this study are expected to be published in 2024. Ethics approval has been obtained.
CONCLUSIONS: It is expected that the psychological well-being of the intervention group will be better compared with that of the control group after the intervention at 3-month follow-up and at 6-month follow-up.
TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20180809040746N1; https://irct.behdasht.gov.ir/trial/33286.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/53692.
OBJECTIVE: The aim of this study is to compare and assess interventions that address AMR across the One Health spectrum and determine what actions will help to build social and ecological capacity and readiness to sustainably tackle AMR.
METHODS: We will apply social-ecological resilience theory to AMR in an explicit One Health context using mixed methods and identify interventions that address AMR and its key pressure antimicrobial use (AMU) identified in the scientific literature and in the gray literature using a web-based survey. Intervention impacts and the factors that challenge or contribute to the success of interventions will be determined, triangulated against expert opinions in participatory workshops and complemented using quantitative time series analyses. We will then identify indicators using regression modeling, which can predict national and regional AMU or AMR dynamics across animal and human health. Together, these analyses will help to quantify the causal loop diagrams (CLDs) of AMR in the European and Southeast Asian food system contexts that are developed by diverse stakeholders in participatory workshops. Then, using these CLDs, the long-term impacts of selected interventions on AMR will be explored under alternate future scenarios via simulation modeling and participatory workshops. A publicly available learning platform housing information about interventions on AMR from a One Health perspective will be developed to help decision makers identify promising interventions for application in their jurisdictions.
RESULTS: To date, 669 interventions have been identified in the scientific literature, 891 participants received a survey invitation, and 4 expert feedback and 4 model-building workshops have been conducted. Time series analysis, regression modeling of national and regional indicators of AMR dynamics, and scenario modeling activities are anticipated to be completed by spring 2022. Ethical approval has been obtained from the University of Waterloo's Office of Research Ethics (ethics numbers 40519 and 41781).
CONCLUSIONS: This paper provides an example of how to study complex problems such as AMR, which require the integration of knowledge across sectors and disciplines to find sustainable solutions. We anticipate that our study will contribute to a better understanding of what actions to take and in what contexts to ensure long-term success in mitigating AMR and its impact and provide useful tools (eg, CLDs, simulation models, and public databases of compiled interventions) to guide management and policy decisions.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24378.
OBJECTIVE: This study aims to develop and validate "Chance2Act," a new web-based intervention, designed specifically to facilitate behavioral change in adults with T2D with obesity who are not ready to act toward weight loss. Then, the effectiveness of the newly developed intervention will be determined from a nonrandomized controlled trial.
METHODS: A web-based intervention will be developed based on the Transtheoretical Model targeting adults with T2D with obesity who are not ready to change for weight loss. Phase 1 will involve the development and validation of the web-based health intervention module. In phase 2, a nonrandomized controlled trial will be conducted in 2 government health clinics selected by the investigator. This is an unblinded study with a parallel assignment (ie, intervention vs control [usual care] with an allocation ratio of 1:1). A total of 124 study participants will be recruited, of which 62 participants will receive the Chance2Act intervention in addition to the usual care. The primary outcome is the changes in an individual's readiness from a stage of not being ready to change (precontemplation, contemplation, or preparation stage) to being ready for weight loss (action stage). The secondary outcomes include changes in self-efficacy, decisional balance, family support for weight loss, BMI, waist circumference, and body fat composition.
RESULTS: The phase 1 study will reveal the intervention's validity through the Content Validity Index and Face Validity Index, considering it valid if both indices exceed 0.83. The effectiveness of the intervention will be determined in phase 2, where the differences within and between groups will be analyzed in terms of the improvement of stages of change and all secondary outcomes as defined in the methodology. Data analysis for phase 2 will commence in 2024, with the anticipated publication of results in March 2024.
CONCLUSIONS: If proven effective, the result of the study may give valuable insights into the effective behavioral modification strategies for a web-based intervention targeting adults with T2D with obesity but not yet ready to change for weight loss. This intervention may be replicated or adopted in different settings, focusing on behavioral modification support that patients need. This study offers a deeper understanding of the application of behavior change techniques for a more holistic approach to obesity care in T2D.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05736536; https://clinicaltrials.gov/study/NCT05736536.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48313.
OBJECTIVE: This study protocol examines the impact of the ecosystem on health literacy among rural communities in protected areas.
METHODS: This study comprises 5 phases. In phase 1, we conduct a systematic review to identify the issue of health literacy in protected areas. In phase 2, we will collect data from stakeholders in a protected area of Pahang National Park and analyze the results using Net-Map analysis. In phase 3, we will conduct a survey among the adult community in Pahang National Park related to health literacy, socioeconomic status, health expenditure, and quality of life. In phase 4, informed by the results of the survey, we will determine suitable intervention programs to improve health literacy through a focus group discussion. Finally, in phase 5, we will conduct a costing analysis to analyze which intervention program is the most cost-effective.
RESULTS: This study was funded by Universiti Sains Islam Malaysia (USIM) and strategic research partnership grants, and enrollment is ongoing. The first results are expected to be submitted for publication in 2024.
CONCLUSIONS: This is one of the first studies to explore health literacy among rural communities in protected areas and will provide the first insights into the overall level of health literacy in the protected community, potential determinants, and a suitable intervention program with expected cost analysis. The results can be used to promote health literacy in other protected areas and populations.
TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Registry ISRCTN40626062; http://tinyurl.com/4kjxuwk5.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51851.
OBJECTIVE: This study aims to determine the feasibility and effectiveness of a digital parenting program (called Naungan Kasih in Bahasa Melayu [Protection through Love]) delivered in Malaysia, with varying combinations of 2 components included to encourage engagement. The study is framed around the following objectives: (1) to determine the recruitment, retention, and engagement rates in each intervention condition; (2) to document implementation fidelity; (3) to explore program acceptability among key stakeholders; (4) to estimate intervention costs; and (5) to provide indications of the effectiveness of the 2 components.
METHODS: This 10-week factorial cluster randomized trial compares ParentText, a chatbot that delivers parenting and family violence prevention content to caregivers of preschool-aged children in combination with 2 engagement components: (1) a WhatsApp support group and (2) either 1 or 2 in-person sessions. The trial aims to recruit 160 primary and 160 secondary caregivers of children aged 4-6 years from 8 schools split equally across 2 locations: Kuala Lumpur and Negeri Sembilan. The primary outcomes concern the feasibility and acceptability of the intervention and its components, including recruitment, retention, and engagement. The effectiveness outcomes include caregiver parenting practices, mental health and relationship quality, and child development. The evaluation involves mixed methods: quantitative caregiver surveys, digitally tracked engagement data of caregivers' use of the digital intervention components, direct assessments of children, and focus group discussions with caregivers and key stakeholders.
RESULTS: Overall, 208 parents were recruited at baseline December 2023: 151 (72.6%) primary caregivers and 57 (27.4%) secondary caregivers. In January 2024, of these 208 parents, 168 (80.8%) enrolled in the program, which was completed in February. Postintervention data collection was completed in March 2024. Findings will be reported in the second half of 2024.
CONCLUSIONS: This is the first factorial cluster randomized trial to assess the feasibility of a hybrid human-digital playful parenting program in Southeast Asia. The results will inform a large-scale optimization trial to establish the most effective, cost-effective, and scalable version of the intervention.
TRIAL REGISTRATION: OSF Registries; https://osf.io/f32ky.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55491.
OBJECTIVE: This paper outlines the protocol for a study to determine the association of vitamin D status and VDR sequence variants among Malaysian pregnant women with HDP.
METHODS: This prospective study consists of two phases. The first phase is a cross-sectional study that will entail gathering medical records, a questionnaire survey, and laboratory testing for vitamin D status, with a planned recruitment of 414 pregnant women. The questionnaire will be utilized to assess the risk factors for vitamin D deficiency. The vitamin D status will be obtained from measurement of the vitamin D (25-hydroxyvitamin D3) level in the blood. The second phase is a case-control study involving a Malay ethnic cohort with vitamin D deficiency. Participants will be divided into two groups with and without HDP (n=150 per group). Genomic DNA will be extracted from the peripheral blood monocytes of participants using the Qiagen DNA blood kit, and VDR sequence variants will be determined using polymerase chain reaction-high-resolution melting (PCR-HRM) analysis. Sanger sequencing will then be used to sequence randomly selected samples corresponding to each identified variant to validate our PCR-HRM results. The VDR genotype and mutation frequencies of BsmI, ApaI, TaqI, and FokI will be statistically analyzed to evaluate their relationships with developing HDP.
RESULTS: As of December 2023, 340 subjects have been recruited for the phase 1 study, 63% of whom were determined to have vitamin D deficiency. In the phase 2 study, 50 and 22 subjects have been recruited from the control and case groups, respectively. Recruitment is expected to be completed by March 2024 and all analyses should be completed by August 2024.
CONCLUSIONS: The outcome of the study will identify the nonmodifiable genetic components contributing to developing vitamin D deficiency leading to HDP. This will in turn enable gaining a better understanding of the contribution of genetic variability to the development of HDP, thus providing more evidence for a need of customized vitamin D supplementation during pregnancy according to the individual variability in the response to vitamin D intake.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05659173; https://clinicaltrials.gov/study/NCT05659173.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53722.