Clinical Research Directory

Effect on Body Weight Reduction of a Behavioral Intervention on Lifestyle Using a Digital Nutritional Program in People Living With HIV and Metabolic Dysfunction-associated Steatotic Liver Disease

Metabolic dysfunction-associated steatotic liver disease (MASLD) is now the leading cause of chronic liver disease in people living with HIV (PLWH). Currently, there are no approved medications to treat this condition. That's why weight loss through healthy lifestyle changes is the most important way to manage it. This study will test if a digital nutritional program (DNP), using a mobile phone app, can help improve weight loss better than the usual advice on healthy eating and exercise. The study includes people living with HIV, aged 18 and older, with fatty liver (detected by ultrasound or other scans), and on stable HIV treatment. Participants will be randomly assigned to two groups: * Intervention group: Will receive personalized lifestyle support through a mobile app (DNP). * Control group: Will receive general advice on healthy habits. The study will last 12 months, with follow-up visits during and after the program. What Will Be Measured: * Weight, waist size, blood pressure, and body fat. * Blood tests to check cholesterol, sugar levels, liver enzymes, and other markers. * Liver scans to assess fat and stiffness. * Questionnaires on eating habits, exercise, and satisfaction with the program. Goals of the Study: Main goal: To see how many people lose at least 5% of their body weight after 6 months. Other goals: To see the effects on weight after 12 months, and 6 months after stopping the program, and to monitor improvements in liver health. Why This Matters: This study aims to find new ways to help people with HIV improve their liver health and overall well-being through simple, practical tools like a mobile app.

Early Life Intervention in Pediatrics Supported by E-health

Childhood obesity in early life contributes to the development of specific NCDs, i.e. adult obesity. Unhealthy diet and low level of physical activity are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of NCDs. Early preventive measures to improve lifestyle behavior are of utmost importance. The aim of ELIPSE-I is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering total energy intake/total energy expenditure (TEI/TEE) ratio in their children with BMI \>97 centile (ELIPSE-I).

Intensive Diet and Physical Activity on Diabetes

It is a multicenter, open-label, parallel-group, randomized controlled clinical trial, which is designed to enroll newly diagnosed type 2 diabetes patients with overweight or obesity. The patients are randomized to an intensive diet intervention (intermittent very-low -calorie diet), enhanced physical activity intervention (high-intensity interval training exercise prescription combined with resistance training) or standard education group (diabetes health education only, including lifestyle education and guidance) for 12 weeks. This trial will test the primary hypothesis of whether an intensive lifestyle treatment (diet or physical activity) is more effective than a standard education in glycemic control. The secondary hypotheses are to compare the intensive lifestyle treatment with a standard education on adipose distribution, metabolic parameters, metabolic molecules, Framingham Risk Scores, and quality of life, et al.

Cardiovascular Disease Prevention Strategies for High-risk Urban Sedentary Employees in Karachi, Pakistan

Heart diseases and other non-communicable diseases are serious health issues in countries like Pakistan. Many people who work in offices, like bank employees, sit for more than 8 hours a day. This is called a sedentary lifestyle, and it increases the risk of heart diseases. This research project aims to find out if a newly developed context specific mobile phone application can help these sedentary employees to improve their lifestyle. The app, called m-LIfE (mHealth-based Lifestyle Intervention for Employees), will be designed to help employees to move more during the day and eat healthier food like fruits and vegetables. The study will involve bank employees in urban Karachi, Pakistan. They will be divided into two arms: Intervention arm: Participants in this arm will use the m-LIfE app for 12 weeks. They will get reminders and tips to take breaks, exercise, and eat healthy. Routine care arm: Participants in this arm will receive printed basic educational material about prevention of risk factors of heart diseases and improving lifestyle. After the 12 weeks of intervention, there will be a follow-up period at 4th week to check if participants are maintaining healthy habits. This study could help find simple and affordable ways to improve the health of office workers and reduce pressure on the healthcare system.

A Mobile Phone Text-based Intervention to Reduce Sedentary Behavior and Engage Communities on the Importance of Healthy Lifestyles: the TEXT2MOVE Study

To learn if an 8-week, phone-based texting intervention program will reduce sedentary (non-mobile) behavior.

Analysis of the Personality Characteristics and Lifestyle of Young People Who Access Psychiatric Outpatient Clinics

Considering the growing importance of services psychiatric and psychological for adolescence and adulthood incidence of discomfort expressed in this age group, comes assessed the need to provide adequate and targeted services. Reasons: The study aims to evaluate the characteristics and trends of adolescents who access the service, in order to frame the type of discomfort expressed and the expectations with respect to access to the service and the resource base on which it can the therapeutic intervention must be thought out and organised. Furthermore, the study aims to identify the factors that influence the request for help and evaluate the quality of the assistance received, with the aim of improving it effectiveness.

Effect of Physical Activity Pattern on Cardiometabolic Health

The goal of this study is to understand the interaction between the circadian system and physical activity. Participants will: * complete 2 inpatient stays * perform moderate exercise * be provided with identical meals * have frequent blood draws * provide urine and saliva samples

PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes

Nearly half of adults in the United States have or are at risk of developing type 2 diabetes. The overall goal of this community-engaged research is to examine the efficacy of an innovative couple-based lifestyle intervention to prevent type 2 diabetes that is applicable to a broad range of partnered adults in the United States. By simultaneously targeting lifestyle and perceived support from romantic partners, there is a high likelihood of creating lasting changes in both

Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception

The purpose of this study is to determine whether an intervention combining motivational interviewing and follow-up with a mobile phone application will help overweight women and their partners adopt healthy lifestyle habits in the preconception period. This study will also evaluate the impact of the intervention on the weight, waist circumference, and body fat of women and their partners. Women and their partners will be followed through pregnancy to explore the effects of the intervention on the adequacy of gestational weight gain, rates of pregnancy complications, delivery mode, and infant birth weight.

The Effect of an App-based Intervention on Quality of Life in Patients With Endometriosis.

The goal of this clinical trial is to learn if an App-based intervention affects the quality of life in patients with suspected or confirmed endometriosis. The main questions it aims to answer are: * Does the App-based intervention improve the quality of life? * Does it lead to pain relief? Researchers will compare participants using the App to a control group to see if the App works to improve quality of life and endometriosis-related symptoms. Participants will: * Use an App-based intervention or be in the control group (no App-use) for 6 months * Visit or have a telephone consultation after 3 and 6 months * Complete a questionnaire to assess the quality of life at inclusion, after 1, 3 and 6 months

Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes

The aim of the study is to test the efficacy, feasibility, and safety of a bicycle exercise followed by an intensive lifestyle intervention for 3 months in patients with recent onset and medically untreated type 2 diabetes.

Effects of General Health Risk Factors on Prolonged Hospital Stay

According to the literature, a detailed preoperative anesthesia assessment systematically verifies perioperative risks, provides functional and physiological optimization, improves the patient's condition and the perioperative process, and prevents complications. In this context, the investigators aimed to determine the frequency of lifestyle risk factors in patients who applied to investigator's clinic for preoperative anesthesia assessment due to adult gastrointestinal endoscopy, to investigate the relationship between lifestyle risk factors and factors and outcomes during the anesthesia procedure, and to compare the effects of these risk factors on developing complications and hospital stay.

The Laughter, Pregnancy, Anxiety and Llife Quality

Gestational Diabetes is one of the most common medical complications during pregnancy. It is seen between the 24th and 28th weeks of pregnancy with the increase in insulin resistance in the second trimester and ends with the end of the birth process. Due to this feature, it is distinguished from Type 2 diabetes. This disease, which is seen for the necessary energy needs of the fetus and placenta, is defined as the diabetogenic effect of pregnancy. Laughter is a universal response to humorous stimuli that exists in our lives. Laughter yoga is holistic with breathing techniques. It is a form of yoga that utilizes the brain's inability to distinguish between real and fake laughter. Laughter yoga helps people cope with stressful times and helps the person control themselves by reducing negative cognitive reactions. In line with this information, the aim of the study was to determine the effect of laughter yoga applied to pregnant women with gestational diabetes on perceived stress and quality of life.

Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline

FINGER-NL is a multi-center, randomized, controlled, multidomain lifestyle intervention trial among 1,206 older adults at risk for cognitive decline with a duration of 24 months. Participants are randomized in a 1:1 ratio to a personalized multi-domain lifestyle intervention (high-intensity intervention group) versus online access to general lifestyle-related health information (low-intensity intervention group). After the intervention period, participants are invited for a 24 month extension of follow-up.

Scottish Advanced Fetal Research Study

In-utero exposure to drugs and chemicals through maternal smoking, alcohol use, drug abuse, prescription medicines and occupational/lifestyle exposures is widespread. Such exposures can alter fetal development and programming, leading to the effects becoming "locked in" from birth and causing long-term adverse consequences for the individual. These include costly and widespread conditions such as obesity, hypertension, metabolic syndrome and infertility. The weight of evidence linking these conditions to fetal recreational drug or environmental chemical exposures, including cigarettes, alcohol, air pollution, food contact materials, is overwhelming. What is lacking is an understanding of how fetal drug exposure translates to adult ill-health and this is due, largely, to an inability to study the problem directly in affected human fetuses. The investigators, and others, have shown that human fetal development, which lays the foundations of adult health and function (fetal programming), is quite different from the rodent and frequently exhibits surprising aspects. It has become evident that the close interconnectivity of the developing fetal organs and also the placenta, means that a much more holistic approach to research aiming to understand human fetal development and the challenges posed to programming for a health adulthood is critical. To that end the investigators have established a carefully considered gestational age range (7-20 weeks of gestation) of fetuses we can study together with multiple fetal organs and body fluids collected and maternal information recorded. The overarching objective of the study is to intensively and systematically study the human fetus during a normal pregnancy and pregnancies where aspects of maternal lifestyle and environment will challenge the fetus. The investigators aim to provide fundamental information to better understand the mechanisms involved and to detect and treat or ameliorate adverse effects during pregnancy (such as maternal smoking/drinking, deprivation, exposure to pollution). In the long term findings from this research will be important for future studies aimed at enabling better health in later life.

Early Life Intervention in Pediatrics Supported by E-health - SMOKE

Unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (NCDs). Exposure to secondhand tobacco smoke in early life contributes to the development of specific NCDs in children, i.e. asthma. Early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. The aim of ELIPSE-II is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children .

A Group Intervention for Promoting Health-related Habits (LEV-G)

Health-related habits influences mental and physical health. Still, treatment of health-related habits, which can help to remedy health problems, is often not done at all or very superficially. Multiple guidelines emphasize the importance of prioritizing health-related habits, but there is a lack of implemented models. To solve this, the investigators have developed a transdiagnostic, interprofessional material intended for several care settings. The Lev-g intervention is intended for groups. There is also an individual version of Lev that has its on registration in Clinical Trails.

Endocrine Disruptors and Life STILe in Breast Cancer Development

The aim of the study is to evaluate the role of lifestyle and environmental factors ( environmental contaminants such as Cd) on the penetrance of BRCA1/2 genes in BRCAm patients with Breast cancer and/or Ovarian cancer and in BRCAm healthy women without cancer diagnosis

Preventing Cognitive Decline: The CITA GO-ON Multi-domain Intervention Study

The GOIZ ZAINDU Gipuzkoa - GO - ON Study is an intervention trial to evaluate the efficacy of dementia prevention strategies in cognitively frail people. It is a large-scale randomized controlled trial in over 1000 older adults between 60 and 85 years old with increased CAIDE risk score (≥6), non-demented but with low performance in at least one of three brief cognitive tests. Participants will be randomized to receive standard health advice (SHA-control) or a multidomain intervention (MM-Int) consisting of 1) Risk factor control (vascular factors, polypharmacy); 2) Cognitive training, 3) Physical activity, 4) Dietary changing program, and 5) emotional counseling and social engagement. The primary aim is to demonstrate a 20% reduction in the proportion of subjects who decline in their NTB performance (z score) after 24 months in the intervention group compared to the controls. Secondary aims include: 1) Analyze cost-effectiveness; 2) Show a beneficial effect of the intervention on functional abilities, quality of life, and depressive and anxiety symptoms; 3) Investigate the impact of a lifestyle intervention on aging. In this sense, biological samples and neuroimaging studies will be collected to allow exploratory investigations on aging mechanisms, amyloid imbalance, tau pathology, epigenetics, neuroinflammation, vascular dysfunction, lipid dysregulation, white matter disintegration, cognitive and brain reserve. This protocol is participant-centered, empowering citizens since the recruitment process to gain access to knowledge about their dementia risk status via web or by phone and then decide to participate. Intervention activities have also taken into account participants' perspective with the design of easy-to-use and appealing activities (e.g., using a self-administered at-home physical activity program such as VIVIFRAIL© and EXERCITA© cognitive training materials that have been developed, taking into account the Basque Country population's cultural, linguistic and educational particularities; and diet and nutritional workshops with famous chefs to learn innovative and attractive healthy recipes). The GO-ON trial may shed light on the tools that people need to fulfill the expectation of an active, healthy dementia-free aging. These include digital tools that in the COVID19 pandemic have shown to be effective in removing distance barriers. GO-ON uses them to give support and expand the possibilities to clinical assessment settings and intervention delivery. The digital part of the intervention may expand preventive actions to small rural areas, including digital socialization. GO-ON Study, which starts in summer 2021, is the first large-scale lifestyle intervention trial in Southern Europe that takes part in the WORLDWIDE FINGERs network and will help answer whether the FINGER results can be replicated. The intervention design has been made on the basis that if proven to be efficacious, it may be easily applied at a Public System-level to guarantee a rapid and easy translation of research results to Primary Care settings and people homes.

Health-Enhancing Adapted Physical Activity Program at "Mon Stade"

Introduction: Regular practice of exercise or physical activity (PA) is a recognized intervention as a determinant of good health acquisition, maintenance, or recovery for a large number of chronic pathologies. Nevertheless, few studies have evaluated adherence to an initial health-adapted PA (APA) program, and persistence of active behavior over the time in individuals with a chronic disease. The aim of the study is to determine the brakes and levers associated with motivation and long-term compliance. In addition, the investigators aim to evaluate the cost-effectiveness of such program in term of care consumption. Finally, the investigators complete their interest for APA prescription from practitioners agreeing to enroll their patients in the present study. Method: The investigators perform a prospective monocentric cohort, of 2024 patients affected of a chronic disease or long-term illness (LTI), enrolled from 2021 to 2024 (4 years, 506 per year), for a 16-week APA program, and followed 5 years with an annual fitness and habits of life and care consumption evaluation.

LIMIT Early Adiposity Rebound in Children

Childhood obesity is a strong predictor of adult obesity with health and economic consequences for the individual and society. Adiposity rebound (AR) is a rise in the Body Mass Index occurring between 3-7 years. Early adiposity rebound (EAR) occurs at a median age of 2 years and is a risk factor for later obesity. Events happening in "the first 1,000 days" play a role in obesity development. One of the key elements in this crucial time window is the gut microbiome, a highly dynamic organ that is sensitive to environmental exposure being linked to obesity development. Prenatal (dietary/lifestyle maternal factors and environmental exposure) and postnatal determinants (the type of feeding, sleep patterns, speed of growth) and environmental obesogenic pollutants may influence the infant microbial colonization, thus increasing the risk of EAR onset. LIMIT will holistically identify the longitudinal interplay between the intestinal microbiome and infant/maternal nutritional and lifestyle habits, environmental factors exposure and anthropometric measurements, in children with AR vs EAR, driving new mechanistic insights to create an EAR predictive model. The study will evaluate a group of 150 mother-infant pairs, during the first four years of life at different follow-up.

STOP DIABETES - Knowledge-based Solutions

The aim of the Stop Diabetes - Knowledge based solutions (StopDia) consortium project (University of Eastern Finland, National Institute for Health and Welfare, and Technical Research Centre of Finland) is to develop and test approaches to identify individuals at increased risk of type 2 diabetes and to empower them in adopting and maintaining a healthy lifestyle by combining individual and environment level strategies into a dual-process approach targeting deliberative and automatic processes of behavior. We also aim to identify barriers and facilitators of adopting a healthy lifestyle in the society, create a model for the prevention of type 2 diabetes by joint actions of health care, third sector, and other societal actors, and develop methods to monitor the cost-effectiveness of these actions. We will carry out a 1-year randomized controlled trial on the effects of among 10 000 individuals aged 18-70 years at increased risk of type 2 diabetes living in Finland. The participants will be randomized into the control group, the digital lifestyle intervention group, or the combined digital and face-to-face lifestyle intervention group. The aim of the interventions is to enhance diet quality, increase physical activity, decrease body weight, and improve glucose tolerance in individuals at increased risk of type 2 diabetes.