Search Bar & Filters
Found 7 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating a mobile health application designed to help women with gestational diabetes mellitus (GDM) better manage their condition during pregnancy. The study focuses on patients in a peri-urban hospital setting in Nepal and aims to address the growing burden of GDM, especially in low- and middle-income countries where the prevalence is rising rapidly. The app is developed using a user-centered design and based on behavior change theory to improve knowledge, self-efficacy, and adherence to recommended diet and physical activity. The intervention includes a culturally tailored smartphone app called GDM-DH, which collects data such as carbohydrate intake, daily activity, blood glucose, and blood pressure measurements taken at home. The study will enroll 120 women newly diagnosed with GDM and 100 women with a high glucose challenge test (GCT) but not diagnosed with GDM. Participants will be randomly assigned to receive either standard care alone or the GDM-DH app plus standard care. Women with GDM will also receive telemonitoring support. The app provides visual displays of patient data to assist healthcare providers in clinical decision-making and counseling. Participants will be involved from less than 30 weeks gestation through delivery, with data collection on maternal blood glucose at 6 weeks postpartum and neonatal outcomes including birth weight, cesarean delivery rates, and neonatal hypoglycemia up to 16 weeks after recruitment. The study includes focus groups, usability testing, and feedback sessions during app development. Participants must own a smartphone with internet access and be able to understand Nepali. Safety monitoring will include assessments for any learning difficulties or sensory impairments that might affect participation.
Actively Recruiting
Neonatal and infant mortality, along with issues like low birth weight and preterm birth, remain significant challenges worldwide, especially in low and middle-income countries. These problems are often linked to poor maternal health, nutrition, smoking, and lack of awareness. This research focuses on using mobile health (mHealth) technology to improve birth outcomes and infant health in Nepal by providing educational support to pregnant women. The study includes an initial qualitative phase where pregnant women at Dhulikhel Hospital participate in focus group discussions to identify barriers and preferences for perinatal care. Based on these insights, user-centered educational videos and tailored mHealth interventions are developed. In a randomized controlled trial, pregnant women between 14 and 22 weeks of gestation are assigned to either an intervention group receiving these educational videos, SMS messages, and reminder phone calls, or a control group receiving standard care with a control video and follow-up reminders. Participants are followed from enrollment until their child reaches one year old. Assessments include knowledge of perinatal care, birth outcomes such as birth weight and gestational age, and infant growth and development at scheduled immunization visits. Data collection involves questionnaires and regular contact from researchers to encourage video viewing and follow-up adherence, aiming to evaluate the effect of the mHealth intervention on maternal and infant health.
Actively Recruiting
Researchers are evaluating a community health worker-led hypertension prevention and control program (CHPC) in central Nepal to assess its implementation and clinical outcomes among adults with hypertension. This hybrid type III study uses a cluster-randomized trial design to compare the CHPC program against facility-based interventions. The study aims to measure program reach, adoption, implementation fidelity, maintenance, effectiveness on systolic blood pressure, and cost-effectiveness over one to two years. The CHPC program involves trained female community health volunteers (FCHVs) delivering hypertension management through group meetings or home visits every three months for one year. The intervention includes blood pressure monitoring, identifying and reporting high blood pressure individuals, personalized counseling on lifestyle changes, medication adherence support, and goal setting based on established hypertension protocols. Health coordinators and monthly meetings support capacity building and program monitoring. Participants will have four follow-up contacts over 12 months, either group sessions or home visits led by community health workers. Researchers will collect various data including blood pressure measurements, surveys, anthropometric data, and qualitative interviews to evaluate implementation and clinical outcomes. The primary outcomes measured include reach, adoption, program implementation, and maintenance up to 24 months, with effectiveness assessed by changes in systolic blood pressure at 12 months.
Actively Recruiting
Healthy Volunteer
Researchers are conducting a large multi-country project to estimate the prevalence of high-risk human papillomavirus (HPV) infections among girls and women aged 9 to 50 years in South Asia and sub-Saharan Africa. The study also aims to understand the incidence of persistent HPV infection over two years among sexually active young women. Alongside these surveys, qualitative studies will explore how gender norms and stigma affect HPV risk and access to prevention and treatment services. The study uses two main approaches: cross-sectional surveys (CSS) and longitudinal studies (LS). The CSS will enroll girls and women aged 9-50 from urban and rural areas, collecting urine samples for HPV testing and gathering data on demographics, sexual history, and HPV awareness. The LS will follow sexually active girls and women aged 15-35 for up to 24 months, testing for persistent HPV infection every six months using self-collected vaginal swabs and urine samples. In some countries, blood samples may also be collected. Qualitative sub-studies involving interviews and focus groups will be conducted in selected countries to better understand risk factors and barriers. Participants will provide samples and complete questionnaires on demographics, sexual and reproductive history, HPV vaccination, and screening. The study will measure HPV prevalence at a single time point and the incidence of infections lasting six months or longer. Safety and ethical considerations include informed consent for adults or assent with guardian consent for minors. The study is planned to run from late 2023 through 2026, with ongoing data collection and analysis across multiple countries and populations.
Actively Recruiting
Researchers are evaluating the effectiveness of pelvic floor muscle training (PFMT) for urinary incontinence (UI) in Nepalese women aged 18 to 45 years. UI, which involves involuntary urine leakage, can significantly affect quality of life and social interactions. This study specifically focuses on women experiencing UI and aims to assess how well PFMT works in this population, as previous studies have not examined its effectiveness in Nepalese women. Participants will first receive education about UI, pelvic floor muscles (PFM), PFMT, and lifestyle changes such as maintaining a healthy weight and proper toilet habits. After this educational session, women will be randomly assigned to either receive education only or education plus supervised PFMT. The PFMT group will attend twelve weekly face-to-face sessions led by a women's health physiotherapist, with exercises tailored to each participant's ability and encouraged to be done daily at home with a recording diary. The intervention period lasts one year. Throughout the study, participants will complete the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at baseline, 12 weeks, 6 months, and 12 months to measure changes in UI symptoms. At the end of 12 months, additional self-efficacy and knowledge questions will be assessed. Data collected will help develop future guidelines for managing UI in Nepalese women and include socio-demographic information, knowledge of UI, and experience with PFMT.
Actively Recruiting
Healthy Volunteer
Diabetes Mellitus is a chronic condition requiring lifelong management, with insulin therapy being a key treatment for many patients. This research evaluates how video-based health education affects the knowledge and practice of insulin therapy among adults with diabetes at Dhulikhel Hospital. The study aims to improve patient education, treatment adherence, and overall health outcomes by providing accessible and visual learning tools tailored for insulin therapy. Participants will be randomly assigned to two groups: one receiving the usual care plus a video-based health education program guided by the Health Belief Model, and the other receiving usual standard diabetic care alone. The video covers topics such as insulin types, administration techniques, and storage. Both groups will continue to receive standard diabetic counseling and health teachings from the hospital. Participants will undergo assessments before and after the intervention to measure their knowledge and practice of insulin therapy over four months. Researchers will collect data through interviews and questionnaires, focusing on improvements in insulin administration skills and understanding. The study uses block randomization to assign groups and monitors safety and adherence throughout the trial period.
Actively Recruiting
Maternal mortality remains high in Nepal, with many deaths occurring within 48 hours after delivery and during the late postpartum period. Postnatal hemorrhage and hypertensive disorders are leading causes. Despite efforts, postnatal care services are rare and often low quality, with many women not attending postnatal checks due to lack of awareness, distance, government support, and cultural factors. This research aims to explore barriers and enablers to postnatal care attendance and evaluate an mHealth intervention to improve postnatal visit uptake, family planning use, and exclusive breastfeeding. The study includes qualitative and quantitative parts. Qualitative research involves focus group discussions with postnatal mothers to understand behavioral factors affecting postnatal care based on the COM-B model. The quantitative part is a randomized controlled trial with 300 third trimester pregnant women divided into intervention and control groups. The intervention group receives educational videos on postnatal care and newborn care during pregnancy, which are then saved on their phones for repeated viewing. They also receive about 13 educational reminder SMS messages postpartum focusing on postnatal visits, family planning, and breastfeeding. The control group receives standard care. Participants will be followed up to measure outcomes such as the number of postnatal visits attended, adoption of postpartum family planning methods, exclusive breastfeeding practice, and care-seeking for danger signs. Implementation outcomes like acceptability, adoption, feasibility, and sustainability of the mHealth approach will be evaluated using interviews and records. Assessments include baseline interviews, postnatal knowledge evaluations, and system usability scales. The total study duration includes pregnancy through three months postpartum, with outcome measures focused at six weeks and three months after birth.