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NCT ID: NCT05571995 Not yet recruiting - Clinical trials for Occupational Diseases

RCT of TRIMOSH Module in Improving Knowledge, Attitude, and Practice Among Food Industries Workers

TRIMOSH
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Introduction: The food and beverages industry contributed a significant income to Malaysia's Gross Domestic Products. The contribution is projected to swell more in the upcoming years. As the industry expands, the demand for the workforce in the food premises will also continuously increase. They are exposed to risks arising from physical, chemical, biological, mechanical, and social hazards while performing their duties. Thus, it is essential for Food Industries Workers to be equipped with the proper knowledge, attitude, and practice (KAP) towards safety and health. Methods and analysis: Theory Based Intervention Module on Occupational Safety and Health (TRIMOSH) is a single blinded, cluster randomized controlled trial study will be implemented among Food Industries Workers in Selangor, Malaysia. Partnering with the Food Handler Training School in Selangor, 10 pairs of Food Handler Training School with 12 participants per group (n = 240) will be recruited for balanced randomization intervention and control conditions. Data collection of all participants will be at enrollment, one months and three months. Generalized Linear Mixed Model (GLMM) will be conducted to determine the effects of intervention within and between study groups. Primary outcomes are to increase knowledge, attitude, and practice (KAP) and secondary outcome is safe practice score at food premise. Ethic and Dissemination: his study has been submitted for approval by the Ethics Committee for Research involving Human Subject of Universiti Putra Malaysia (JKEUPM-2022-346). All participants will provide consent prior to participation. The results will be reported in international peer- reviewed journals and presented at conferences and other platforms.

NCT ID: NCT05526040 Not yet recruiting - Clinical trials for Head and Neck Cancer

Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study

HaNIS
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

This is a prospective, randomized, open-label intervention study to evaluate the effectiveness of immunonutrition supplementation in head and neck cancer (HNC) patients during cancer treatment.

NCT ID: NCT05498285 Not yet recruiting - ACL Injury Clinical Trials

Post-ACL Reconstruction Rehab UPSCALER App RCT HPUPM

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

EXECUTIVE SUMMARY Research Title An Android Application-Based Delivery of Guided Rehabilitation After Anterior Cruciate Ligament Reconstruction: A Randomised Single-Blinded Pilot Study Investigators Principle Investigator (Supervisor) : Prof Madya Dr Mohd Nizlan Mohd Nasir Co-investigator (Supervisor) : Dr Khairil Anwar bin Ahmad Hanif Dr Firdati binti Mohamed Saaid Co-Investigator (Student) : Dr Tan Eng Kee Background Anterior cruciate ligament injuries are a common and significant injury seen in active persons. This injury can adversely affect the patient's daily life, as well as delay or prevent return to sports, in addition to predisposing patients to long-tern knee conditions such as osteoarthritis. Despite surgical advances, ACL reconstruction surgery outcomes are still considered poor, with a low as 55% of patients returning to active sports. One of the key factors that lead to a poorer outcome is the patient's compliance to rehabilitation, causing less than satisfactory results in the post-operative period. With the conventional regime, rehabilitation typically takes one year. Patients tend to drop out of the rehabilitation regime due to its long duration. In order to combat this, the accelerated regime was developed and only took 6 months. This regime has been researched and validated by numerous international publications since its inception. However, compliance remained poor. Purpose of Study The study aims to assess the feasibility and effectiveness of a smartphone-based application to guide the patient's rehabilitation regime and improve compliance. Data Gathering and Analysis Data for outcome assessment will be obtained via a patient administered questionnaire called the Knee Injury and Osteoarthritis Outcome Score (KOOS). This scoring system is available for free without licensing requirements, and has been validated by numerous research publications internationally. Analysis of obtained data will be performed using SPSS version 22. Continuous data will be displayed as mean + SD as well as median. Conclusion There is a need for a new method of information provision as the country moves towards the age of information technology. This smartphone-based application for guided rehabilitation will be an innovative new method to aid patients. Lastly, the researchers would like to thank the members of JKEUPM for their time, effort and kind consideration of this research proposal.

NCT ID: NCT05489536 Not yet recruiting - Pregnant Women Clinical Trials

Optimizing Gestational Weight Gain for Prevention of Gestational Diabetes Mellitus in Malaysia

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Gestational weight gain (GWG) has been closely related to health outcomes, particularly in gestational diabetes mellitus (GDM). Pregnant women may be particularly motivated to make healthy lifestyle changes. Previous studies showed that lifestyle modification interventions (diet and exercise) may be successful in reducing GWG in high-risk women but their effects on the incidence of GDM and other adverse perinatal outcomes have been limited. The research question for the future full randomized trial is whether an optimizing healthy GWG programme focusing on lifestyle (diet and physical activity) feasible to decrease the risk of GDM in a developing country. Thus, this study aims to evaluate the effectiveness of a web/smartphone-based lifestyle program in optimizing gestational weight gain (GWG) to prevent the incidence of GDM.

NCT ID: NCT05445193 Not yet recruiting - Picky Eating Clinical Trials

PEaters Choice™: Nutrition Intervention Module for Picky Eaters

PEaters
Start date: March 2023
Phase: N/A
Study type: Interventional

Picky eaters (PE) are defined as individuals with a lack of diversity in food intake and fear of trying new foods which generally leads to malnutrition. Globally, between 20% to 55% of children worldwide are being reported as PE. Malaysia particularly has 31.8% PE children. To date, limited comprehensive modules on dietary recommendations are designed to help parents and/or primary healthcare workers to address this issue. This study is a single-blind randomized controlled trial to evaluate the effectiveness of PEaters Choice™ designed for PE children aged three to five years, with the objective to increase the food repertoire of the children. The PEaters Choice™ is a 12-week intervention program designed for mother, father or guardian-child dyads. The dyads will be divided into two groups; Intervention and Control Group. This trial will require each group to complete a list of commonly eaten foods, Child Eating Behavior Questionnaires, and a set of anthropometric data. Intervention groups will then follow three phases of the intervention program. This module suits primary healthcare settings, helping parents or guardians strategize meal planning, hence lowering the risk of malnutrition among PE children.

NCT ID: NCT05444179 Not yet recruiting - Clinical trials for Postpartum Depression

Nutrition and Physical Activity Intervention on Psychosocial Well-Being of Postpartum Mothers

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

This study aims to examine the effectiveness of nutrition and physical intervention to improve psychosocial well-being of postpartum mothers with preterm infants. The focus was highlighted towards the mothers of preterm infants who were cared in Neonatal Intensive Care Unit (NICU) as these parents might have a higher stress level than the full-term infants. The intervention consisted of a module designed for postpartum mothers, incorporating nutrition and physical activity entitled Mommies can Eat & Exercise with No Stress (MomEENS).

NCT ID: NCT05396027 Not yet recruiting - Clinical trials for Psychological Stress

Study of Effectiveness of Audio Guided Deep Breathing on Improving the Quality of Life of Physically Disabled Group

Start date: August 2022
Phase: N/A
Study type: Interventional

Diaphragmatic breathing brings different advantages to improve physical and mental health but it could be difficult for the physically disabled group to follow the practice by themselves especially those with vision impairment. Therefore, guided deep breathing is desirable to address their needs but these are rarely analyzed in the previous literature. This research aims to study the physiological impacts and psychological health of audio-guided deep breathing on physically disabled groups. The psychological changes will be assessed by Perceived Stress Scale (PSS), World Health Organization Quality of Life (WHO-BREF) and Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Besides, physiological parameters such as tidal volume, electroencephalography, hair cortisol level and heart rate variability are measured non-invasively to evaluate the impact of audio-guided deep breathing. Furthermore, auditory Go-No Go Task will be adopted as a neuropsychological test in determining changes in response control and sustained attention in this study as well. Eventually, the pre-and post-interventional data will be analyzed and processed to study the effect of audio-guided deep breathing on these special groups.

NCT ID: NCT05335096 Not yet recruiting - HIV Infections Clinical Trials

An AI-based mHealth Intervention to Improve HIV Testing

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to develop an artificial intelligence (AI)-chatbot-based mobile health (mHealth) intervention to promote HIV testing in Malaysia.

NCT ID: NCT05271097 Not yet recruiting - HIV Clinical Trials

mHealth HIV Prevention for Transgender Women

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis compared to treatment as usual.

NCT ID: NCT05232201 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Vitamin D Levels and Heart Rate Variability on Endothelial Function Via RAAS Augmentation in OSA

RAAS_OSA
Start date: February 2022
Phase:
Study type: Observational

The role of obstructive sleep apnea (OSA) in contributing to hyperaldosteronism, which can lead to increased morbidity and mortality, is less well-established. The vitamin D levels and sympathetic activity of patients with obesity and OSA have not been explored in detail. In this cohort, the role of vitamin D and sympathetic activity, either individually or in combination, on augmenting the renin-angiotensin-aldosterone system (RAAS) causing more endothelial dysfunction remains elusive. We aim to evaluate renin angiotensin aldosterone system in OSA population; elucidate relationship between aldosterone and vitamin D levels in patients with OSA; and to determine association between aldosterone level and vitamin D deficiency with cardio-metabolic derangement in patients with OSA. This is a cross-sectional study involving 150 patients confirmed to have OSA. Participants who fulfil study criteria and consent to study will have blood withdrawn for aldosterone, renin, 25OHD levels with bone profile, and metabolic profile; undergo ultrasound flow mediated dilatation of brachial artery to assess endothelial function; ultrasound of hepatobiliary system to assess fatty liver; 24-hour Holter monitoring to assess sympathetic function; WHOQOLBREF to assess quality of life and Pittsburgh Sleep Quality Index to assess sleep quality.