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Life Style clinical trials

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NCT ID: NCT05395364 Active, not recruiting - Obesity Clinical Trials

A Health Promotion Intervention for Vulnerable School

BeE-school
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The BeE-school (Be Empowered in school) is a cluster-randomised trial that addresses the complexity of the social challenge (vulnerable school-age children). It aims to analyse the effectiveness of the intervention program, based on the promotion of health literacy and lifestyles, specifically on children's: 1-health literacy and infodemic resilience (Aim 1); 2- lifestyles (e.g. dietary intake, 24hmovement behaviour) (Aim 2); 3-overweight and obesity (Aim 3); 4-blood pressure (Aim 4). The project converges multiple disciplines (e.g. public health, informatics, law) and researchers with proven expertise in these fields to provide comprehensive and innovative answers. 478 children (6 schools) aged 6-12years old will participate in this cluster-randomised trial, having schools as the unit of randomisation, assigned into intervention (239-3schools) and the control arm (239 - 3 schools). This project will perform a social listening (online and offline) and bottom-up approach to tackling NCDs, focusing on health literacy and health promotion and recognising children's systems in daily life (e.g. family, teachers). Stakeholders' involvement goes far beyond a merely consultative approach; the researchers are committed to a genuine codevelopment process. Data collection includes sociodemographics, health literacy and infodemic resilience, dietary intake and children's 24-h movement behaviour (e.g. accelerometry), anthropometry (e.g. weight, height and waist circumference) and blood pressure. Data collection will occur at baseline and after the intervention (follow-up, 6 months after the beginning of the intervention). Expected outputs and outcomes include the creation of a model for characterising NCDs and health topics based on artificial intelligence techniques (e.g. deep learning, and social network analysis methods); improved health literacy and infodemic resilience of children, families and teachers; enhanced children's lifestyles (e.g. dietary intake, 24-h movement behaviour); reduction of NCDs' physical risk factors (e.g. overweight, raised blood pressure); feasible intervention program about health promotion and NCDs' prevention for school-aged children with vulnerabilities, and advocacy- policies about health promotion and NCDs' prevention.

NCT ID: NCT05394779 Active, not recruiting - Obesity Clinical Trials

DEMETRA - ADVICE-002-2022

Start date: August 23, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and performance of DTXO App in improving weight loss and weight-loss maintenance in obese patients exposed to an experimental non-pharmacological treatment program. The App will include a dietary plan and customized advice program, a customized physical exercise program plan, a cognitive- behavioral assessment and support program, alerts and reminders on prescribed drugs intake and on dietary and exercise program, chat and online visits with clinical professionals, and trophies to improve patient engagement.

NCT ID: NCT05377398 Completed - Mental Health Clinical Trials

MIELITEKO Lifestyle Intervention Study

MIELITEKO
Start date: August 24, 2022
Phase: N/A
Study type: Interventional

Mental health problems cause individual, social and economic burden to the society. The mental health problems are among the highest levels in North Savo compared to the general Finnish population. The COVID-19 pandemic has emphasized the urgent need for tackling mental health problems and developing an effective and comprehensive approach to prevent mental health problems. The aim of this MIELITEKO pilot study is to test and develop an effective and comprehensive programme to prevent mental health problems and promote mental wellbeing among disadvantaged groups. The pilot study is a multilayered intervention study with an RCT study design, which will be conducted in selected cities and areas in North Savo such as Kuopio, Iisalmi, Varkaus and Siilinjärvi. The disadvantaged groups of this study include people aged between 18 and 64 years who are unemployed or are outside the workforce. The participants are randomized 1:1 into intervention (N=250) and control groups (N=250). The intervention group will receive the multilayered intervention whereas the control group is assumed to continue with current health information and use of services "as usual" but remain in the waiting list. Multilayered intervention includes individual-level digital healthy lifestyle intervention, group-based healthy lifestyle intervention and green power intervention as well as mini-intervention for substance use. The data collection of self-reported validated measure of health and wellbeing as well as relevant background factor will be conducted using digital and online survey tools in baseline (T0), and after 6 months (T1) and 12 months (T2) after the onset of the study from both intervention and control groups. Register data on the use of services and pharmaceuticals that will be gathered from the national registers at National Institute for Health and Welfare and Kela or from local registers administered by municipalities in North Savo. Pilot study will utilize quantitative and qualitative statistical analyses to evaluate the process, effects and effectiveness as well as cost-effectiveness of the intervention to promote mental health and wellbeing as well as to healthy lifestyles.

NCT ID: NCT05256199 Active, not recruiting - Cognitive Decline Clinical Trials

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

FINGER-NL
Start date: February 24, 2022
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT05217108 Recruiting - Healthy Lifestyle Clinical Trials

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

Start date: January 5, 2022
Phase: N/A
Study type: Interventional

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

NCT ID: NCT05117580 Recruiting - Metabolic Syndrome Clinical Trials

Telemedicine With Metabolic Syndrome

METSZI
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on cardiovascular risk factors, functional indicators, in patients with metabolic syndrome.

NCT ID: NCT04965415 Completed - Life Style Clinical Trials

Small+Safe+Well: A Longitudinal Study of TWH in Small Business

SSWell
Start date: April 1, 2017
Phase: N/A
Study type: Interventional

Workers in small businesses bear a disproportionate burden of occupational fatalities, illnesses, and injuries. The investigators conducted an intervention research project to determine how an intervention at the organizational level modifies business Total Worker Health (TWH) practices, safety climate, and health climate. In turn, the investigators aimed to determine whether organizational TWH adoption impacts individual workers' lifestyle health outcomes. In addition, the investigators also evaluated the use of the RE-AIM public health impact evaluation framework in the small business setting, with the intention of improving generalizability, maintenance, and dissemination of interventions and of guiding future TWH intervention design for both research and practice. The investigators conducted a lagged randomized controlled trial (L-RCT) to determine how different doses of an organizational-level TWH intervention (Health Links vs. Health Links + TWH Leadership Training) resulted in improvement and maintenance of TWH programming and organizational climates for safety and health, in small enterprises, over 36 months. The investigators also evaluated whether it resulted in improvements in workforce lifestyle health risks. In the short and mid-term, the goals and outputs of this project is a greater understanding of the theoretical underpinnings of TWH interventions and a model to test the implementation of the TWH interventions as well as an improvement the ability of TWH researchers and practitioners to apply this knowledge to TWH intervention design, implementation and evaluation to ensure generalizability. The long-term goal of this project is to impact worker safety, health and well-being through the continued use of these principles in small businesses.

NCT ID: NCT04960670 Not yet recruiting - Childhood Obesity Clinical Trials

LIMIT Early Adiposity Rebound in Children

LIMIT
Start date: December 1, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT04840030 Enrolling by invitation - Dementia Clinical Trials

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

CITA GO-ON
Start date: December 3, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04749004 Completed - Life Style Clinical Trials

A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents

healthy tyrol
Start date: September 23, 2021
Phase: N/A
Study type: Interventional

Students at the age of 14-16 years will be randomized to one intervention arm or one control arm in a 1:1 ratio. Participants of both groups receive a fitness tracker to count the amount of their steps taken. The participants of the intervention arm will commit themselves to a personal goal of steps taken by means of a commitment contract. Achievement of the goal will be rewarded with financial incentives to fulfill the requirements of proper reward medium, according to the Induced Value Theory (Smith, 1976). The duration of the intervention will be 1 year; incentives are provided for 6 months, the remaining 6 months are the follow-up period. The hypothesis is that intensified motivational strategies like the provision of commitment contracts and nudges are effective in increasing the number of steps taken per month compared to a control group.