Clinical trials

This randomized controlled trial aims to evaluate the effectiveness and implementation of a Just-in-Time Digital Learning Platform designed to improve teachers' oral health literacy and support the delivery of oral health education in schools. Teachers play an important role in promoting healthy behaviors among children, but many have limited access to structured oral health training. Digital microlearning approaches may provide a scalable and cost-effective solution for strengthening teacher capacity in school-based oral health promotion. Teachers assigned to the intervention group will receive access to a digital learning platform that delivers short, interactive, and evidence-based oral health training modules through mobile devices. The platform will provide educational content, reminders, quizzes, feedback, and progress monitoring. Teachers in the control group will receive standard information or routine training practices. The study will assess changes in teachers' oral health literacy, knowledge, attitudes, and confidence in delivering oral health education. It will also evaluate implementation outcomes, including acceptability, feasibility, adoption, fidelity, reach, and engagement with the digital platform. In addition, the study will examine whether improvements in teacher training lead to better oral health knowledge, behaviors, and clinical oral health outcomes among students.

This research is a single-blinded, 12-week, two-arm cluster randomized controlled trial to evaluate the effectiveness of a Malaysian-adapted MIND (Mediterranean-DASH Intervention for Neurodegenerative Delay) diet retort meal intervention on sarcopenia risk, cognitive frailty status, nutritional status, depression, functional ability, and food security among older adults in Malaysia. With Malaysia projected to become an aged society by 2030, addressing age-related health challenges, including cognitive frailty and sarcopenia, is a national priority. Current evidence indicates that poor diet quality and food insecurity among older adults, especially those in low-income urban communities, exacerbate these conditions. The study is grounded on the Meals on Wheels (MoW) program, which has been effective in reducing malnutrition among older populations globally but is limited in scalability due to high delivery costs. Retort meals which are shelf-stable and nutritionally balanced offer a feasible alternative for meal provision in poor urban settings. The MIND diet, originally designed to support brain health, also demonstrates benefits for muscle health and overall physical function. However, its adaptation to the Malaysian context is crucial due to cultural dietary preferences and cost barriers to certain ingredients. The intervention will recruit 70 older adults (aged 60-84 years) from Program Perumahan Rakyat (PPR) Seri Alam Fasa 2 and Perumahan Awam (PA) Loke Yew in Kuala Lumpur, classified under the B40 income group and at risk of food insecurity. The intervention group will receive retort meals designed according to the adapted MIND diet principles, while the control group will not receive intervention. Data will be collected at baseline, 6 weeks, and 12 weeks to assess outcomes in muscle health, cognitive frailty, nutritional status, depression, functional ability, food security, and cost-effectiveness. Overall, the conceptual framework provides a structured approach to understanding how the intervention contributes to improved nutritional well-being and supports the economic viability of the Meals on Wheels program. Potential confounding variables, including socioeconomic status, baseline health conditions, social support, and lifestyle factors, may also influence the outcomes. Participants will fill up a questionnaire regarding their sociodemographic characteristics, medical factors, psychological factors, lifestyle factors, food security status, functional ability, and depression status. Besides, the researcher will conduct face-to-face interviews to collect data regarding anthropometric measurements, handgrip strength, medical costs, and diet history. Statistical analyses will employ mixed-effects models to evaluate both continuous and categorical outcomes over time. The findings will generate crucial evidence on the feasibility, effectiveness, and cost-efficiency of using retort meals within MoW programs in Malaysia. Furthermore, it will inform national strategies to address food insecurity, promote healthy ageing, and reduce the burden of age-related health conditions. With Malaysia's rapidly ageing population and increasing prevalence of sarcopenia and cognitive frailty, this study has the potential to shape policy and practice by offering a sustainable, culturally tailored nutrition intervention. The evidence derived will support the scaling up of MoW programs using retort meals and contribute to long-term solutions for improving the quality of life and independence of older adults in Malaysia.

This study aims to evaluate whether eating biscuits made with mature okra flour can help young adults feel fuller (enhance satiety) and change certain blood markers compared to eating standard biscuits. Mature okra is a nutrient-dense agricultural by-product that is often discarded due to its tough texture. For this study, mature okra pods are dried and ground into a flour, which is then used to replace 10% of the wheat flour in a custom biscuit formulation. Participants will take part in a single-blind, randomised trial where they will consume either the okra-incorporated biscuits or the standard control biscuits on separate occasions. Researchers will measure participants' perceived fullness over 165 minutes using a visual rating scale. Blood samples will also be collected at specific intervals during this time to evaluate blood glucose levels, appetite-related hormones, and metabolic responses.

Medication non-adherence leads to recurrent admissions, worsening symptoms, poor quality of life, and increased healthcare costs in an already overburdened health system. Existing adherence interventions in Pakistan are limited, mostly educational, and rarely guided by behavioural theory, implementation science, or economic evaluation. Therefore, a culturally appropriate, RE-AIM-informed autonomy-competence intervention is needed to improve medication adherence and quality of life among heart failure patients in Pakistan, while also assessing implementation feasibility and cost-effectiveness for future scale-up.

The goal of this InTroDuce-Programme interventional trial aims to test whether a web-based educational program can improve pregnant women's knowledge about Influenza and Tdap vaccinations and increase their intention to get vaccinated in the future. The main questions it aims to answer are: Does the InTroDuce-Programme increase knowledge and future intention of pregnant mothers to get vaccinated against Influenza and Tdap? How does demographic factors, attitudes and barriers affect vaccination decisions among pregnant mothers? Researchers will compare InTroDuce-Programme to standard care (routine antenatal care) to see if InTroDuce-Programme works to improve knowledge and future intention of pregnant mothers to be vaccinated against Influenza and Tdap. Participants will: Receive the web-based educational module (InTroDuce-Programme), which covers the importance, safety, and effectiveness of vaccinations, as well as addressing common concerns. Be followed up one month after the intervention. Answer questionnaires before and after the intervention to measure changes in vaccination knowledge and future intention to get vaccinated

This study evaluates an ergonomics intervention to reduce work-related musculoskeletal disorders (MSDs) among dental healthcare workers in Dubai government hospitals, where up to 90% prevalence affects the lower back, neck, shoulders, and upper extremities due to repetitive tasks and postures. Using a cluster randomized controlled trial (RCT) across three hospitals (55 participants per intervention/control group), it assesses MSD prevalence/severity, mental health, physical activity, and KAP scores at baseline, post-intervention, and three-month follow-up. Analyses include logistic regression, ANOVA, and GEE. Expected outcomes: identify predictors and demonstrate intervention efficacy via education, environmental, and behavioral changes, informing UAE occupational health policies.

The goal of this RCT trial is to learn if internet-based group cognitive behaviour therapy delivered via the Zoom application works to treat anxiety and depression among international students. It will also learn about the predictive factors of the intervention's effectiveness. The main questions it aims to answer are: * Does participating in internet-based GCBT reduce the symptoms of anxiety among international students in Malaysia? * Does participating in internet-based GCBT reduce the symptoms of depression among international students in Malaysia? Researchers will compare students who take part in the intervention program with students in a waitlist control group to understand whether the intervention is associated with changes in anxiety and depression symptoms. Participants will: * Be randomly assigned to either the intervention program or a waitlist control group * Attend four sessions of one hour each, including 1) psychoeducation, 2) cognitive techniques, 3) behaviour techniques, and 4) support and relapse prevention. A booster session and a follow-up assessment will be done1 month post intervention.

Metabolic syndrome (MetS) is a global health issue defined by a cluster of risk factors-abdominal obesity, elevated blood pressure, high fasting blood sugar, high triglycerides, and low HDL cholesterol-that together significantly increase the risk of cardiovascular disease, type 2 diabetes, and overall mortality. Globally, about 20-25% of adults are affected, but prevalence varies by region and population; in Saudi Arabia, studies report rates ranging from 28.3% to 56.4%, with higher rates observed in northern and central regions and among men. Major contributors to MetS in Saudi Arabia include obesity, sedentary lifestyle, smoking, and poor dietary habits, such as low fruit consumption. Effective management strategies focus on weight loss through caloric restriction, intermittent fasting, and increased physical activity, all of which have demonstrated improvements in metabolic markers like insulin sensitivity, blood pressure, and lipid profiles. Despite international evidence supporting these interventions, no randomized controlled trials have yet evaluated the combined effects of these approaches on MetS biomarkers in Saudi adults, underscoring the need for targeted research and public health initiatives to address the high and regionally variable burden of MetS in the country.

The goal of this clinical trial is to learn if the Nurses' Stress Self-Care Educational Program (NSSCEP) can reduce burnout and occupational stress in Jordanian pediatric oncology nurses. The main questions it aims to answer are: 1. Does NSSCEP reduce symptoms of burnout in pediatric oncology nurses? 2. Does NSSCEP improve stress management skills among pediatric oncology nurses? Researchers will compare nurses participating in the NSSCEP to a control group receiving a general technical skills program to see if NSSCEP reduces burnout and improves stress management. Participants will: 1. Attend four educational sessions over one month, focusing on stress recognition, coping strategies, and resilience-building techniques 2. Complete weekly checklists to track their application of stress management skills 3. Participate in pre- and post-intervention surveys to assess burnout and stress levels

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.

The goal of this clinical trial is to compare the effect of perioperative immunonutrition supplement in gynecologic cancer patients. The main questions it aims to answer are: * is there any difference in the nutritional outcomes and functional outcomes between intervention and conventional groups? * is there any difference in the post-surgical outcomes between intervention and conventional groups? Participants (intervention) will be provided the immunonutrition supplement before and after operation. Researchers will compare intervention group with conventional group to see if there is any difference in postoperative outcomes.

Schools provide an ideal setting for early interventions. Evidence suggests that educational programs incorporating behavioural change theories can improve oral hygiene practices and clinical outcomes. A School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School Children for six months, while the control group will receive no intervention, only routine care.

Dental caries remains a significant global public health issue, particularly affecting children's health, development, and well-being, with inadequate knowledge, attitudes, and practices around oral health exacerbating these impacts. To address this, a cluster randomized controlled trial will be conducted in four primary schools in Al Lith City, Saudi Arabia, targeting children aged 10 to 11 years. The intervention involves interactive, classroom-based educational sessions led by a dental care professional, supplemented by take-home materials, focusing first on enhancing knowledge and attitudes, and then on developing behavioral skills for improved oral hygiene and eating habits. Participants' knowledge, attitudes, and practices will be assessed via questionnaires before, immediately after, and six months post-intervention, with data analyzed using SPSS through descriptive statistics, chi-square tests, One Way-ANOVA, and Generalized Estimating Equations. The study expects that school-based oral health education will significantly improve children's oral health knowledge and certain hygiene behaviors, as well as positively influence eating habits and patterns.

This study is a 6-month, pragmatic, multi-center, sequentially recruited, stratified, open-label randomized controlled trial (RCT) conducted in Malaysia. It aims to determine the clinical effectiveness of a culturally adapted, gamified mobile health app (MyNutriKidney®) supplementing standard care, compared to standard care alone, for improving dietary self-management among 200 adults with Chronic Kidney Disease (CKD) stages 3-5. Participants will be randomly assigned (1:1, stratified by age and education) into either (i) the intervention group (MyNutriKidney® app + standard care) or (ii) the control group (standard care, including routine dietary counseling and printed materials). The co-primary outcomes are changes in Dietary Adherence (measured by CKD Diet Score) and Nutrition Literacy (measured by NLS score) from baseline to 6 months.

Diabetes mellitus is the ninth leading cause of mortality worldwide. Diabetes is a chronic condition with a major impact on the life and well-being of individuals, families, and societies globally. The three main types of diabetes are type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM), and gestational diabetes mellitus (GDM); approximately 90% of the total cases accounts for T2DM. T2DM is characterized by chronic hyperglycaemia and affects 9.5% of adults aged 20-99 years. The highly burdensome condition is predominantly prevalent in elderly population and distresses 19.3% of elderly aged 65-99 years. Elderly with diabetes have poor Health related Quality of Life (HRQoL) in comparison with their peers of similar age from the general populations. The determinants of poor HRQoL in elderly with T2DM diabetes population are - poor glycemic control, long duration of diabetes, multiple co-morbidities, depression, high body mass index (BMI), poor self-management practices, higher diabetes related distress, low social support and increased social isolation. Diabetes Self-management Education and Support (DSME/S) is a critical element of care to improve the overall condition of diabetic patients. Self-care does play a critical role in elderly diabetes management. The goal of the current clinical trial is to develop and assess the effectiveness of peer supported diabetes self-care intervention in improving the HRQoL in elderly with type 2 diabetes.

This study is designed to compare the effects of four relaxation interventions on both physiological and psychological outcomes in lactating mothers of preterm infants. The interventions being tested include: * Guided Imagery Meditation (GIM) * Religious Recitation (RR) * Infant Video with Music * Distraction with News and Media * A Control session The primary objectives of the study are to evaluate and compare how these different relaxation techniques influence the physiological and psychological well-being of mothers and identify which intervention is most effective for lactating mothers who deliver prematurely. The main research questions are: 1. How do different interventions (GIM, RR, Infant Video with Music, Distraction with Media, and Control) affect physiological and psychological outcomes when measured within the same participants? 2. Are there significant differences in physiological and psychological outcomes when participants are exposed to different interventions (GIM, RR, Infant Video with Music, Distraction with Media, and Control) within the same group? 3. Among the interventions, which one demonstrates the most beneficial effects on physiological and psychological outcomes within the same participants? Study Design: Each participant will be exposed to five different sessions (one for each intervention), with a gap of 1-2 days between sessions. The interventions will be administered as follows: * Guided Imagery Meditation (GIM) * Religious Recitation (RR) * Infant Video with Music * Distraction with News and Media * A Control session Expected Outcomes: This study will assess the following physiological and psychological outcomes: Physiological changes: * Heart Rate (HR) * Systolic Blood Pressure (SBP) * Diastolic Blood Pressure (DBP) * Fingertip Temperature (FT) * Breast milk cortisol concentration Psychological changes: •. Perceived Relaxation

This study aims to develop, implement, and evaluate an educational program-based intervention on the knowledge, attitude, and practice toward renal nutrition among dietitians working with chronic kidney disease (CKD) patients in public hospitals in Saudi Arabia. The study hypothesizes that there will be a significant improvement in the knowledge, attitude, and practice of renal nutrition among the dietitians in the intervention group compared to the control group after the implementation of the educational program. The findings will contribute to enhancing the ability of dietitians to provide effective nutritional care and support for CKD patients in Saudi Arabia.

The purpose of this study is to find out if plyometric training has an effect on lower limb explosive strength and skill performance in Latin dancers. The aim is to answer the following questions: 1. Does augmented style training increase dancers' lower limb explosive strength. 2. Whether plyometric training promotes specialized dance skills. 3. The relationship between lower limb explosive strength and specialized dance skills. The researchers set up an experimental group and a control group, the experimental group uses plyometric training and the control group performs traditional training, and finally, between-group and within-group comparisons are made. Participants will: Train for 90 minutes three times a week for eight weeks. Participants' lower limb explosive strength and skills will be measured before the start of the experiment and at the end of the experiment.

The goal of this clinical trial is to investigate the outcome of plant-based omega-3 intervention on lipid profile and blood pressure after 12 weeks and to study the molecular markers associated with the incidence of CVD risk. The main questions it aims to answer are: * What is the role of plant-based omega-3 intervention on lipid profile and blood pressure of individuals with CVD risk after 12 weeks? * What is the association between unique molecular markers and plant-based omega-3 intervention among individuals with CVD risk? Participants will be subjected to two groups: * Treatment group: Receive standard dietary therapy and plant-based omega-3 supplemental beverage consumed once daily during breakfast * Control group: Receive only standard dietary therapy Researcher will compare between treatment and control group to see the effect of plant based omega-3 on lipid profile and blood pressure after 12 weeks

This mother-infant cohort study aims to determine the geographic differences in the microbial profiles in breast milk from mothers living in Malaysia and China that are potentially important determinants of infant development. It also aims to determine the impact of gut microbiome on infant health (temperament, gastrointestinal symptoms, eczema symptoms, and asthma symptoms).

A playroom and a playground are already part of the stabilization unit and are furnished with basic facilities for engaging the SAM children in play-based motor, language, and personal-social activities. The severely acute malnourished children in the intervention group will be sent to a development pediatrician who will do a developmental assessment of the child and stimulation. A sensory therapist, an occupational therapist, and a physiotherapist will also be available for sessions.

Digital health using mobile health (mHealth) tools, such as telehealth and text messaging, and or mobile Apps can improve blood glucose levels in patients with type 2 diabetes. This intervention is designed to improve self-management of diabetes and blood glucose levels in diabetic patients.

Patients with psychiatric disorders, including depression, anxiety, and schizophrenia, often require antipsychotic medications for symptom management. However, metabolic changes, especially weight gain, are a common and challenging side effect of many antipsychotics. Aripiprazole, an atypical antipsychotic, has shown promise in mitigating this adverse effect when used in combination with other antipsychotic medications.

Globally, chronic noncommunicable diseases rank as the leading cause of morbidity and mortality. Diabetes is reaching high epidemic proportions across the globe. The prevalence of diabetes is increasing in Saudi Arabia, with diabetes affecting 14.1% of the population across all age groups and 28% of those over the age of 30. Date seed intake is one of the best-studied patterns. Previous studies findinds showed that the phenolic compounds in date seeds have blood sugar-lowering properties. There is a lack of data on how date seed diets may affect glycaemia control and cardiovascular risk among Saudi Arabian patients with T2DM. Therefore, randomised controlled trials (RCTs) will be conducted to assess the effects of date seeds on glycaemic control and cardiovascular risk among diabetes patients.

Overweight and obesity are prevalent, especially among adolescents. By 2016, over 124 million children and adolescents, comprising 6% of girls and 8% of boys, were classified as obese. Over the past century, childhood obesity has transitioned from a symbol of prosperity and well-being to being acknowledged as a significant health concern. Furthermore, according to the World Health Organization, it is now considered "one of the most serious challenges of the 21st century." Overweight and obese adolescents have serious problems with weight loss, mental health and social-emotional. A previous study by Lopez identified time constraints and a lack of motivation as hindrances to physical activity, a key component of effective weight loss measures. In today's society, developed modern technology plays a very important role in the growth of teenagers and in their daily life. Exergame is a new type of video game that allows participants to be more active, stimulating their whole body movement game experience and promoting non-sedentary physical activity. Active Video Games (AVGs) utilize motion-sensing technology to simplify the complex functions typically associated with computer operations. Exergaming is a novel video game that stimulates an active whole-body gaming experience that allow to play multiple players compete or cooperate on a team. Playing against a peer offering both virtual and real social interaction is more likely to sustain engagement, and also promotes higher energy expenditure in an exergame compared to playing alone. Harnessing adolescents' fascination with video games represents an innovative strategy in the battle against pediatric obesity and sedentary lifestyles. It is especially important to intervene with overweight and obese adolescents using Competitive exergame to become more actively involved in sports, no longer afraid of social interaction, and improve quality of life. Competitive exergame provides a virtual and a real social interaction to improve mental health on overweight and obese adolescents. Therefore, the study will systematically investigate the effects of Competitive Exergame on Weight loss, Mental health,and Social-emotional among overweight and obese male adolescents in China.