Clinical Research Directory

Examining the Acceptability and Effectiveness of a Self-Directed, Web-Based Resource for Stress and Coping in University

University students consistently report high levels of stress and psychological distress and identify these as key factors that negatively impact their academic performance and engagement with their studies. Supporting students in effectively coping with stress and distress is of critical importance to facilitate learning and development in university environments. To that end, technology-based approaches to delivering stress-management and well-being supports to university students have proliferated on campuses as supplemental means of supporting student stress management, coping capacity, and well-being. Indeed, online resources for students' self-directed use such as websites, apps, or on-demand workshops, are increasingly popular given their benefits in improving access to support as well as the potential for reaching students who may be reluctant to seek other forms of mental health support or are on waiting lists for more specialized services. In addition, the provision of resources for addressing stress and enhancing coping capacity is aligned with the recently proposed health theory of coping which calls for enhancing the availability of evidence-based healthy coping strategies. However, investigation into the acceptability and even more critically the effectiveness of online, self-directed resources for non-clinical stress-management and healthy coping support is limited. Thus, this study sought to explore the acceptability and effectiveness of a self-directed, web-based resource for enhancing students' stress-management and coping capacity. Furthermore, the study also examined if there would be any added benefit of screening students to assess stress and coping needs and then directing them to specific resources to match their needs for stress-management and healthy coping support.

Evaluating Knowledge Mobilization Sustainability Approaches

The overarching objective of the current study is to evaluate the effectiveness, acceptability, strategy use, and maintenance of behaviour change of different stress management sustainability groups. Furthermore, the study aims to examine how these sustainability groups and maintenance of behaviour change may impact student wellness in the long term. Specifically, objective 1 sought to compare three commonly employed approaches for sustainability of stress management strategy use (workshop booster sessions, online community drop-ins, digital infographic reminders) and an inactive control group (no support) in terms of their (1.1) effectiveness on wellness outcomes (i.e., stress, healthy and unhealthy coping capacity, mindfulness, coping self-efficacy, and well-being), (1.2) acceptability, (1.3) strategy use, and (1.4) maintenance of behaviour change over time. It was hypothesized that the community drop-in sustainability group would have greater effectiveness, strategy use, and maintenance of behaviour change compared to the other sustainability groups and inactive control. This hypothesis aligns with the literature across both sustainability supports and maintenance of behaviour change-related indices, suggesting that social support is a key element to sustained strategy use. No specific hypothesis was made for which sustainability approach would be rated as most (H1.2) acceptable given this is a novel area of research. Objective 2 sought to examine (2.1) whether maintenance of behaviour change at post (T2) predicted wellness outcomes (i.e., stress, healthy and unhealthy coping capacity, mindfulness, coping self-efficacy, and well-being) at 6-month follow-up (T4), and whether this relationship was differentially moderated by sustainability group. It was hypothesized (H2.1) that maintenance of behaviour change at post would positively predict healthy coping, mindfulness, coping self-efficacy, and well-being and negatively predict stress and unhealthy coping at the 6-month follow-up and that this would be moderated by sustainability group (i.e., workshop booster sessions, online community drop-ins, digital infographic reminders).

Effectiveness of the Sleep Island WeChat Mini-Program for Promoting Sleep in Preschool Children

Behavioral sleep problems are common during the preschool years and are strongly influenced by parental sleep-related practices and the home environment. This randomized controlled trial aims to evaluate the effectiveness of Sleep Island, a parent-focused WeChat mini-program adapted from a theory- and evidence-based parent-child collaborative behavioral sleep promotion program. A total of 122 families with preschool children will be randomly assigned in a 1:1 ratio to either the Sleep Island intervention plus routine sleep-health education or a waitlist control condition receiving routine sleep-health education. The intervention will be delivered over 4 weeks. Sleep Island incorporates electronic sleep monitoring, visualization of sleep patterns, individualized sleep-behavior feedback, sleep-health education, and personalized behavioral recommendations. Recommendations are generated using a large language model supported by retrieval-augmented generation from a curated pediatric sleep knowledge base and are reviewed by the research team before release. Outcomes will be assessed at baseline, immediately after the intervention, and at 3- and 6-month follow-up. The primary outcome will be objectively measured child nocturnal sleep duration. Secondary outcomes will include other objective and parent-reported indicators of child sleep health, parental sleep-related practices, sleep environment, behavioral sleep problems, and parental knowledge, attitudes, self-efficacy, and beliefs regarding child sleep.

Digital Resistance Training for Midlife Women Using GLP-1

The goal of PLAN-RT 1.0 to learn if a 12-week app-based strength training program can help midlife women build and stick with a regular strength training routine while they are taking GLP-1 medication for weight loss. PLAN-RT 1.0 targets women ages 40 to 59 who were not regularly exercising before starting GLP-1 medication. The main questions this study aims to answer are: (1) Is the PLAN-RT 1.0 program feasible and acceptable to participants (based on how many people join, stay in the study, and use the program)? (2) Does the program lead to early changes in muscle strength, body composition, physical function, and exercise habits?

Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

Assess the impact of a remote, app-delivered digital meditation intervention on emotional well-being of lonely older adults. Neuroimaging, electrophysiological (EEG), and autonomic physiology will be used to assess the neural correlates of the intervention. EEG and autonomic physiology will be collected while participants watch 30 min of an awe-inspiring movie. fMRI and autonomic physiology will be collected in the context of a social exploration/exploitation task.

Advancing Precision Medicine for Cardiovascular Disease and Diabetes in Asian Populations: Digital Intervention Cohort

The overarching aim is to improve cardiometabolic health and promote healthy ageing by supporting adults to adopt favourable lifestyle patterns identified through our observational research. The trial will recruit n=600 to be involved in Phase I (referred to as the "Optimisation Phase") of a two-phase project (Phase II trial registration will be submitted separately). All participants will complete a baseline study visit where, after consent taking, will complete a baseline questionnaire, receive a smartwatch each and additional wearables if applicable, and download the study app for the receiving and testing of interventions and completion of short form surveys. Participants will be involved in the continual evaluation and optimisation of ecological momentary interventions (EMIs) in adaptive, factorial, micro-randomised trials over 12 months. Consenting participants may also be contacted to participate in interviews to be involved in the co-design of interventions, or to provide insights to the feasibility and process evaluation of the trial.

Prospective Exploratory Study on the Comprehensive Application Effectiveness of Exercise Prescription Decision Support Tools in the Management of Patients With "Four Highs" (Hypertension, Hyperglycemia, Hyperlipidemia, Hyperuricemia)

This study conducted a six-month exploratory clinical trial to evaluate the impact of an exercise prescription mini-program, based on the "Exercise Guidelines for the 'Four Highs'", on the physical activity levels and related health indicators of patients with hypertension, hyperglycemia, hyperlipidemia, and hyperuricemia in primary healthcare settings in China.

Usability Study of Gestational and Postpartum Weight Management Program

The principal aim of this study is to evaluate the usability of the Hope-D gestational and 6 months postpartum weight management program. We will evaluate the usability, functionality, and acceptability of the developed Hope-D weight management program that includes digital pathway for weight management, general or individual weight management plan and individual or group coaching for weight management from pregnancy to 6 months postpartum.

A Digital Intervention to Improve Oral Health Practices

This study evaluates a 16-week parent-focused digital intervention to improve oral health practices in children aged 6-10 through daily reminders, quizzes, challenges, gamification, and behavior tracking, supported by an optional moderated WhatsApp group for peer engagement and motivation.

Complete Digital Workflow

This study will aim to clinical evaluation of titanium-zirconium and peek-composite of screw retained prosthesis used for rehabilitation of edentulous patients using Complete digital workflow for construction of full arch implant supported screw retained restoration.

Digital Support Intervention for Pregnant People with Opioid Use Disorders

The goal of this pilot randomized feasibility study is to explore the benefits of providing parenting and recovery support for pregnant people with Opioid Use Disorders through digital technology (e.g. smartphones). The main question it aims to answer is: • What is the feasibility of providing customized digital parenting and recovery supports to pregnant people with Opioid Use Disorders residing in natural communities? o Feasibility data includes data on study interest, eligibility, time to enroll, participant training on digital app usage, attrition; Secondary outcome exploratory data will include MOUD treatment retention, missed follow up prenatal and early postpartum appointments, drug usage, and parenting outcomes (i.e., scores on the Parental sense of competency scale, Self-rated abilities for health practices scale, and Self-efficacy in infant care scale) through self-report; The intervention group only will also be observed regarding app usage, frequency of use, resources accessed, thoughts about the app, and what was found to be helpful. Researchers will compare the bibliotherapy control group to determine clinical differences in secondary outcomes. Participants will complete the following tasks: * Schedule an online meeting with the research team to receive more information about the study. Once consented to participate, the participant will be randomly assigned to one of the groups. * Complete survey questions within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about drug usage, missed follow-up medical appointments, and parenting outcomes. The total time to complete the survey after consenting to be in the study will take approximately 40 minutes. The total time to complete the surveys after the six week and 12-week study period should take no more than 30 minutes. * Complete a one-hour virtual interview at three months post-delivery (by phone or computer) about the study experience.

Testing and Comparing the Impacts of Mhealth-Based and Web-Based Education on Oral Cancer

Introduction: Oral cancer is a malignant neoplastic disease affecting the lip, oral cavity (mouth) and/or the oropharynx. Despite the intense and diverse public health interventions on oral cancer prevention, the global prevalence rates of oral cancer and its major risk factors are still very high. Hence, oral cancer is an issue of serious global health importance. Aim: To test and compare the effectiveness, usability, uptake, and acceptability of an educational website and a mobile health application prototype on oral cancer in improving oral cancer knowledge among university students. Methods: This study will adopt a randomised control trial design, and it will be conducted among 75 first-year bachelor's degree students from five universities across two continents: University of Rwanda (Rwanda, Africa), Usmanu Danfodiyo University (Nigeria, Africa), University of Peradeniya (Sri Lanka, Asia), University of Ibadan (Nigeria), and Saveetha University (India, Aisa). The study participants will be in three groups (Group 1, Group 2, and Group 3). The participants in Group 1 will be the control group (n = 25 participants; 5 participants from each university); that is the group that will not receive an educational intervention. However, those in Group 2 (n = 25 participants; 5 participants from each university) will receive a web-based educational intervention on oral cancer while those in Group 3 (n = 25 participants; 5 participants from each university) will receive an app-based educational intervention on oral cancer. Pretest survey and posttest survey will be done for all participants. The data collected will be statistically analysed using the Statistical Package for Social Sciences (SPSS) version 28 software. Descriptive statistics will be done for all variables while inferential statistics (analysis of variance) will be done to test for associations between variables of interest. Conclusion: The findings of this study will determine the effectiveness, usability, uptake, and acceptability of the tested digital intervention tools.