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Behavior, Health clinical trials

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NCT ID: NCT06264258 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Game-based Pediatric Diabetes Education

DVx-T1D
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D). The investigators hypothesize that adoption of DVx-T1D™ by T1D patients will positively influence healthy dietary and physical activity behaviors by providing nutrition and lifestyle education through a playful, Artificial Intelligence (AI)-based, cartoon-style medium of mobile gaming, and result in improvements in their T1D control. The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 T1D participants (40 each in two arms of the trial) of 6-12 years old. The investigators will quantify the impact of the mobile game app plus standard care vs. standard care (with no exposure to the app) on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters measured at home), physical activity levels and food choices of children (measured using food logs and surveys). Game telemetry, food logs, clinical, anthropometric, demographic, and survey data will be collected to obtain adequately powered, theory-driven evidence of the value of game-based approaches delivered via mobile apps.

NCT ID: NCT06259318 Completed - Depression Clinical Trials

Feasibility of Kanasina Gulabi, a Pilot Peer Support Intervention for Young Adults With Type 2 Diabetes in Mysore District, South India

Start date: June 21, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a pilot peer support intervention, entitled "Kanasina Gulabi" (Translation "My Dream Rose" in Kannada), designed to improve quality of life and diabetes management among young adults living with type 2 diabetes. The intervention, delivered by non-specialist providers - trained young adult peer navigators who are also managing type 2 diabetes - is expected to improve physical and mental health outcomes among participants. The sample includes young adults aged 18-40 with a diagnosis of type 2 diabetes in Mysore district, South India. Participants were quasi-randomly allocated to the intervention or control group. With the support of their peer navigators, intervention participants will develop action plans to improve their physical and mental health outcomes. This study plans to assess the feasibility, acceptability, and preliminary effectiveness of the intervention.

NCT ID: NCT06242704 Not yet recruiting - Behavior, Health Clinical Trials

Train Your Brain 2.0 - Improving Memory and Decision Making Among Youth

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to deliver a computer-based working memory training program to improve delay discounting (DD) and prevent substance misuse among at-risk adolescents in a traditionally underserved area. Results from the study will inform future substance use prevention efforts targeted at youth exposed to adverse childhood experiences. Findings will also refine future models of intervention delivery in traditionally underserved communities. The main aims of the project are are: 1) To examine to examine changes in hypothesized mechanisms of substance use initiation and escalation, and 2) to assess whether changes in DD are a mechanism for reducing substance misuse during early adolescence. The investigators will evaluate whether changes in DD following active treatment predict substance use outcomes over the three-month follow-up period.

NCT ID: NCT06238726 Recruiting - Behavior, Health Clinical Trials

Nudging Patients to Increase Shingles Vaccination

Start date: March 25, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to test whether messages encouraging patients to ask about a Shingrix vaccine at an upcoming appointment will increase Shingrix vaccination rates. The study will also test which of several message versions is most effective.

NCT ID: NCT06208345 Recruiting - Childhood Obesity Clinical Trials

Early Life Intervention in Pediatrics Supported by E-health

ELIPSE-I
Start date: February 16, 2024
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT06207084 Not yet recruiting - Physical Activity Clinical Trials

The Fit With Us Study

FITWITHUS
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this 32 week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one on one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre recorded exercise content and articles for another 8 weeks. After final surveys, participants will have open access to the website for another 16 weeks where we will passively observe their fitbit and website data. The study outcomes are: The effectiveness of the adaptive interventions Exploring mediating and moderating variables Sensitivity analysis of the predictive analytics

NCT ID: NCT06145919 Recruiting - Behavior, Health Clinical Trials

Parent-Child Memory Study: Improving Future Thinking Among Mothers

Start date: February 6, 2024
Phase: N/A
Study type: Interventional

Parents of children from impoverished communities are disproportionately more likely to engage in harsh physical discipline, which can lead to serious clinical outcomes, including suicidal ideation and attempts. One mechanism linking low resource environments and maladaptive parenting strategies is maternal delay discounting, or the tendency to value smaller, immediate rewards (such as stopping children's misbehavior via physical means) relative to larger, but delayed rewards (like improving the parent-child relationship). This study will examine the efficacy of implementing a low-cost, brief intervention targeting the reduction of maternal delay discounting to inform broader public health efforts aimed at improving adolescent mental health outcomes in traditionally underserved communities.

NCT ID: NCT06119503 Recruiting - Behavior, Health Clinical Trials

Peer-Delivered Episodic Future Thinking for Returning Citizens

Start date: November 14, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to examine the effectiveness of a brief, episodic future thinking (EFT) intervention in a substance use treatment setting serving returning citizens with substance use disorders (SUD). The main questions it aims to answer are: 1. Determine preliminary implementation potential of the EFT intervention, including acceptability and feasibility of conducting the intervention. 2. Examine the preliminary effectiveness of this approach, with a specific focus on patient outcomes, including changes in delay discounting, treatment retention, treatment motivation, and substance use. Participants will be asked to participant in pre and post assessment questionnaires, participate in a single-episode brief intervention followed by tailored phone call follow-ups.

NCT ID: NCT06114264 Active, not recruiting - Low Back Pain Clinical Trials

Multimodal Intervention in Patients With Non-specific Chronic Low Back Pain: the HEALTHY BACK Project

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

Low back pain is one of the most common health problems seen in the primary care. Chronic low back pain is localized between the inferior limit of the ribs and the sacral region, and persist more than 12 weeks. In most cases, it is attributed to a non-specific cause and classified as non-specific chronic low back pain (NSCLBP). No previous study has included a multimodal supervised program in patients with NSCLBP. The primary aim of this study is to determine the effectiveness of exercise + behaviour change + education + mindfulness programs (intervention 1) and an intervention including intervention 1 following functional resistance training (Intervention 2) on endogenous pain modulation, disability, muscle strength/endurance, quality of life, gait parameters, levels of physical activity, sedentary behaviour and psychological health in patients with NSCLBP.

NCT ID: NCT06089876 Active, not recruiting - Physical Inactivity Clinical Trials

The Use of Mobile Applications in Obese and Overweight Adolescents for Health Improvement

Start date: September 25, 2023
Phase: N/A
Study type: Interventional

Overweight and obesity, understood as an accumulation of abnormal and excessive fat, are the second leading cause of preventable and avoidable mortality in developed countries, with more than 340 million children and adolescents affected by this disease worldwide. As a consequence, overweight and obesity at an early age is already considered a pandemic by the World Health Organization (WHO), with a high incidence in developed countries. The abuse of new technologies has remained at worrying levels in the post-COVID period, favoring an increase in the adolescent population considered sedentary. In this regard, up to 70% of adolescents show sedentary behaviors, especially affecting the time spent on screens by both males (93.8%) and females (87.2%). Thus, the use of the cell phone has been shown to be a determining factor, since between 10% and 16% of adolescents show a problematic use of this device, affecting, among other aspects, their behavior during their free time. In recent years there has been an increase in sedentary time among adolescents and a decrease in the practice of physical activity that has favored a greater accumulation of body fat and increased the probability of being overweight or obese. In this context, some studies have tried to encourage the practice of physical activity in the school context in overweight and obese population, being these interventions effective to improve body composition. However, these interventions also have their detractors, who argue that the hours of Physical Education are too limited to dedicate so much time to a single content, and that the pedagogical component is often overlooked in their implementation. As an alternative to the above, it has been suggested that Physical Education classes could be used to promote interventions that encourage adolescents to practice physical activity in their free time, and mobile applications could be used to monitor the activity carried out by adolescents, but also as an element that generates adherence and enjoyment in this population. Research in this population using these technologies is scarce, therefore, this project aims to determine the effectiveness of a ten-week intervention promoted from the subject of physical education in which a mobile application is used after school hours on physical activity, body composition and fitness in overweight or obese adolescents.