View clinical trials related to Lifestyle.
Filter by:There is an increasing focus on the need to optimise nutrition, lifestyle and metabolism of parents before and during pregnancy and of the infant after birth, but as yet there is limited understanding of the specific influences and of the underlying mechanisms. This study is a follow up of children from the NiPPeR trial of a nutritional drink enriched with micronutrients, myo-inositol and probiotics taken preconception and during pregnancy. In this setting we will examine the influence of parental nutrition, lifestyle and metabolism before and during pregnancy on child growth, development and well-being; ascertaining growth, adiposity, metabolism, neurobehavioural and health outcomes in the children, and characterising the underlying mechanisms. The data collected will allow identification of the contributions of parental and offspring characteristics, nutritional, lifestyle and medical factors, social and economic status, ethnicity, genetics, metabolism and microbes to promoting healthy growth, body composition and wellbeing in the children.
The goal of this clinical trial is to provide evidence, through an extreme exercise prescription (1,144 km of road cycling on seven consecutive days), that weight loss is not the appropriate outcome to evaluate the effects of exercise on abdominal adiposity and ectopic fat depots (e.g. liver fat and epi/pericardial fat) in eleven recreational middle-aged male cyclists (aged 50 to 66 years) without symptoms of cardiovascular disease. The main questions it aims to answer are: - If energy intake is substantially increased to compensate energy expenditure and prevent weight loss following an extreme exercise prescription, will significant changes in body composition and body fat distribution be observed? - Will these changes translate into improvements in the cardiometabolic health profile even in the absence of weight loss? Participants will be asked to partake in several evaluations: fasting plasma lipoprotein-lipid profile and inflammation markers, glycated hemoglobin, cardiorespiratory fitness, submaximal exercise test including measurement of energy expenditure, resting and exercise blood pressure and heart rate, evaluation of regional adiposity, liver fat content, epi/pericardial fat, nutritional quality, and level of physical activity. After baseline evaluations, participants will be asked to alternately bike 208 km and 104 km per day on a pre-specified course for seven consecutive days. They will be accompanied during each of the seven bike rides by research professionals in a recreational vehicle. Participants' weight, body composition and waist circumference will be measured under standardized conditions in the morning after an overnight fast and after the exercise. Their heart rate will be continuously monitored, and participants will wear accelerometers to estimate their daily exercise-related energy expenditure. Foods and fluids will be provided to participants and recorded. At the end of the 1,144 km/ 7-days bike ride, baseline evaluations will be repeated with the exception of the maximal exercise treadmill test, nutritional quality, and level of physical activity. To facilitate the conduct of the protocol, the eleven participants will be evaluated and followed in two distinct groups.
The goal of this clinical trial is to evaluate the effectiveness of innovative integrated care in pre-frail or frail patients with diabetes over 65 years old. The main questions it aims to answer are: - To establish innovative integrated care for frail elderly patients with diabetes combined with nutrition and lifestyle guidance. - To evaluate the effectiveness of the intervention compared with general outpatient care. Participants will receive 12 weeks of structured care including specialist care, integrated assessment, group health education, one-on-one nutrition and lifestyle guidance, online and face-to-face support group, and case management. Researchers will compare general outpatient care to see its effects on frailty, physical function, and blood sugar control.
For people with a severe mental illness (SMI) there is no appropriate lifestyle intervention in ambulatory care, while they would benefit greatly from it. With SMI is meant mainly psychotic-, bipolar- and severe mood or anxiety disorders that require long-term care and counseling. People with SMI have a one-and-a-half to two times higher risk of heart disease, diabetes, and reduced mental health than the general population. This combination contributes to up to 15 years shorter life expectancy and reduced quality of life. Lifestyle plays an important role in this. Combined Support for the Ambulatory Lifestyle Intervention (GOAL!) is a multidisciplinary lifestyle support intervention where people with SMI are supervised for a longer period of time by qualified professionals, with attention to individual wishes and perceived challenges. Although the newly introduced so-called combined lifestyle interventions, that were recently introduced on a national level, follow this line of thinking, people with SMI may not benefit sufficiently from this offer. From the common challenge and need to create improved support, GGz Centraal in cooperation with the municipalities in the North Veluwe and local partners developed GOAL! and will pilot its use. This is done in cooperation with health insurers within the framework of an Innovation Policy Rule of the Dutch Healthcare Authority. The aim of this study is to follow this innovation and evaluate the implementation and effectiveness of GOAL!.
The aim of this study is to evaluate the effectiveness of the nurse-led GILL (Gezondheid in Lichaam en Leefstijl) eHealth intervention in patients with serious mental illness (SMI), compared to usual care. Expected is that the GILL eHealth intervention will be more effective than usual care in improving physical health and lifestyle behaviors. To evaluate this, we will perform a cluster randomized controlled trial with an embedded process evaluation of the implementation of the GILL intervention. 258 adult patients with serious mental illness and a body mass index of 27 or higher (overweight/obesity) will be included. The GILL eHealth intervention consists of two complementary modules for (a) somatic screening and (b) lifestyle promotion, resulting in a personalized somatic treatment and lifestyle plan. Trained mental health nurses and clinical nurse specialists will implement the intervention within the multidisciplinary treatment context, and will guide and support the patients in the promotion of their somatic health, including cardiometabolic risk management. The intervention will be compared to usual care, which includes treatment according to national guidelines. The outcome measures will be metabolic syndrome severity (primary), fitness, physical activity, lifestyle behaviors, quality of life, recovery, psychosocial functioning, health related self-efficacy and health care utilization after 1 year. The process evaluation focuses on the feasibility of the eHealth intervention, its acceptability for patients and health care providers (mainly mental health nurses and clinical nurse specialists), and barriers/facilitators to implementation.
The purpose of this study is to compare the impact of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) on human health outcomes in healthy sedentary subjects, over 12 weeks of exercise training. The investigators will compare several health parameters, such as changes in multiomics profile, cardiorespiratory fitness, muscle strength, and body composition, before and after 12-week interventions of either HIIT or MICT.
Rationale: Adolescent and young adult (AYA) cancer survivors, diagnosed between 18-39 years, much more than children, suffer from delay in diagnosis, lack of centralization of care, age-adjusted expertise and follow-up care. The distribution of tumor types, biology, risk factors, developmental challenges and treatment regimens are different in AYAs compared to children. Therefore findings derived from childhood cancer survivors cannot be extrapolated to AYAs. Likewise, several large tumor-specific cohort studies exist that do not specifically address unique AYA age-specific issues. Globally, so far, the identification of AYA patient subgroups that might be more susceptible to poor health outcomes has not been systematically addressed. The role of sociodemographic and treatment-associated risks, external exposures (e.g. lifestyle) and host factors (e.g. genetic); or combinations of influences for impaired (age-specific) health outcomes, remains largely unknown. Understanding who is at risk and why, will support the development of evidence-based AYA prevention, treatment and supportive care programs and guidelines. Objective: To examine the prevalence, risk factors and mechanisms of impaired health outcomes (health-related quality of life and late effects) among a population-based sample of AYA cancer survivors. Study design: Retrospective, population-based, observational cohort study. Study population: AYA cancer survivors, diagnosed at age 18-39 years between 1999-2015, identified from the Netherlands Cancer Registry (NCR), and alive 5-20 year after diagnosis Main study parameters/endpoints: Health-related quality of life; late effects
Effect of lifestyle modification on pregnancy outcome for pregnant women with GDM
A prospective controlled, randomized study to examine the effects of behavioral and wellness-based interventions on seizure frequency for adult patients with medication resistant epilepsy who are still experiencing 1 or more seizures per month.
Background: Although the health benefits of physical activity are well established, it remains challenging for people to adopt a more active lifestyle. Mobile health (mHealth) interventions can be effective tools to promote physical activity and reduce sedentary behavior. Promising results have been obtained by using gamification techniques as behavior change strategies, especially when they were tailored toward an individual's preferences and goals; yet, it remains unclear how goals could be personalized to effectively promote health behaviors. Objective: In this study, the investigators aim to evaluate the impact of personalized goal setting in the context of gamified mHealth interventions. The investigators hypothesize that interventions suggesting health goals that are tailored based on end users' (self-reported) current and desired capabilities will be more engaging than interventions with generic goals. Methods: The study was designed as a 2-arm randomized intervention trial. Participants were recruited among staff members of Noorderkempen governmental organization. They participated in an 8-week digital health promotion campaign that was especially designed to promote walks, bike rides, and sports sessions. Using an mHealth app, participants could track their performance on two social leaderboards: a leaderboard displaying the individual scores of participants and a leaderboard displaying the average scores per organizational department. The mHealth app also provided a news feed that showed when other participants had scored points. Points could be collected by performing any of the 6 assigned tasks (eg, walk for at least 2000 m). The level of complexity of 3 of these 6 tasks was updated every 2 weeks by changing either the suggested task intensity or the suggested frequency of the task. The 2 intervention arms-with participants randomly assigned-consisted of a personalized treatment that tailored the complexity parameters based on participants' self-reported capabilities and goals and a control treatment where the complexity parameters were set generically based on national guidelines. Measures were collected from the mHealth app as well as from intake and posttest surveys and analyzed using hierarchical linear models. Note: Eindhoven University of Technology is not an official GCP sponsor. Hence, this study is not a medical clinical trial.