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NCT ID: NCT06454773 Recruiting - Intervention Clinical Trials

To Evaluate the Impact of Consumption of Bioactive Compounds Extracted From Hemp Hull and Black Pepper on Fasting Blood Glucose Levels in People With Pre-diabetes: A Randomized Placebo-Controlled Parallel Arm Trial

Start date: June 1, 2024
Phase: Phase 3
Study type: Interventional

This is randomized controlled parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. At the end of the run-in period, subjects fulfilling the inclusion/exclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables. The measured parameters will include, 24-h diet recall, food frequency questionnaire, anthropometry including circumferences, height and weight, and blood parameters including blood glucose (fasting), serum insulin (fasting), HbA1c and lipid profile.

NCT ID: NCT06026904 Recruiting - Intervention Clinical Trials

The Effects of taVNS on Motivation in MDD With Anhedonia

Start date: March 30, 2023
Phase: N/A
Study type: Interventional

Study of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) intervention to improve the reward motivation and response inhibition of major depression disorder and its brain network mechanism.

NCT ID: NCT05949320 Recruiting - Intervention Clinical Trials

"Health in Mobile" for Community-dwelling Individuals With Chronic Diseases

Start date: April 3, 2023
Phase: N/A
Study type: Interventional

This study aims to provide a mobile-apps-based intervention to facilitate individuals with chronic diseases such as high blood pressure and diabetes to adopt healthy behaviours. The intervention is based on Motivational Interviewing, a clinical technique used to enhance an individual's behavioural changes. The proposed research project comprises developing and validating the "Health in Mobile" app, which we call e-MI, which will then be launched to members of the three District Health Centre Express (DCHEs) who have presented with clinical/preclinical chronic health issues such as high blood pressure and diabetes. The participants are registered members of the three DCHEs. The targeted sample size is 1600 members, with 1200 are in the e-MI group while the other 400 are in the waiting list control group.

NCT ID: NCT05820646 Recruiting - Intervention Clinical Trials

Effect of Boswellia Sacra as an Intracanal Medicament on Postoperative Pain Intensity and Bacterial Load Reduction

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

This research will study the effect of Boswellia Sacra versus calcium hydroxide as an intracanal medicament on postoperative pain intensity measured using numerical rating scale (NRS) and bacterial load reduction reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) in mandibular premolars with necrotic pulp.

NCT ID: NCT05738499 Recruiting - Stroke Clinical Trials

The Effectiveness and Mechanism of Character Strengths-based STEP Programme on Rehabilitation of Stroke Patients

STEP
Start date: April 30, 2023
Phase: N/A
Study type: Interventional

There is an urgent need for educational and psychological adjustment to stimulate the post-stroke patients' motivation to actively carry out rehabilitation. Studies have shown that interventions based on character strengths are widely used in chronic disease patients abroad, and have achieved the effect of improving the physical and mental health. However, research on individualized character strengths in stroke patient intervention is limited, and more clinical evidence is needed. This study is based on personality theory and the application of character strengths-based STEP programme (CSSTEP) in stroke patients. The investigators hypothesized that the CSSTEP programme could help stroke patients to improve mental state, cognitive function, and better gait performance, suffer from less post-stroke depression, enhance their post-stroke self-confidence.

NCT ID: NCT05594524 Recruiting - Intervention Clinical Trials

Coach-Led Body Image Intervention for Girls in Sport - RCT

Start date: January 16, 2023
Phase: N/A
Study type: Interventional

According to the World Health Organization, only 15% of 11-17-year-old girls meet the recommended daily physical movement guidelines (e.g., 60 minutes per day). Despite extensive research highlighting the protective factors associated with sport on both mental and physical health, body image concerns are a key barrier to girls' participation in, and enjoyment of, sport. Sports-related environments and society more broadly further exacerbate these concerns through harmful gender stereotypes that perpetuate female objectification, discrimination, and harassment. This includes the promotion of unrealistic and sexualized appearances of female athletes, uncomfortable and objectifying uniforms, and appearance and competence-related teasing from male and female peers, as well as coaches. The magnitude of this issue and how best to address it can be understood from a socioecological perspective. Researchers suggest developing multi-faceted and multi-tiered approaches that have scope for targeting the individual, interpersonal, organizational, and societal levels. The current research will test the first coach-led body image program for girls in sport. The Body Confident Athletes program was co-created with girls and coaches through an international multi-disciplinary partnership between academics, health professionals, industry, and community organizations. Multi-disciplinary partnerships can create a supportive landscape by upskilling girls and influential community members (e.g., coaches) in dealing with body image concerns, which will likely lead to sustained sports participation and biopsychosocial benefits. As such, the aim of the present study is to conduct a large-scale randomized controlled trial (RCT) to evaluate the effectiveness of the Body Confident Athletes program. The program consists of three 60-minute sessions delivered by coaches to adolescent girls. Each session tackles a distinct theme related to body image in the sport context. Outcomes will be assessed at pre-intervention, post-intervention (three weeks later), and follow-up (at one and three months). Outcomes will include body image and sport enjoyment (primary outcomes); body appreciation, attuned self-care, resisting objectification, and positive and negative affect (secondary outcomes); and intervention acceptability, fidelity, and adherence (process outcomes). The comparison control arm will be a waitlist control condition. To undertake this project, sports organizations will be cluster-randomized into the intervention group or the control group, with 800 girls anticipated in each arm. Those in the intervention condition will complete baseline assessments (target outcomes and demographic information), take part in the three-week intervention, and then complete the post-intervention and follow-up assessments (target and process outcomes). Those in the waitlist control condition will complete the baseline assessments (target outcomes and demographic information), a second assessment three weeks later (target outcomes only), and follow-up assessments after one and three months, after which they will get access to the intervention. However, their engagement with the intervention will not be monitored or assessed. At completion of the post-intervention survey, all participants will receive a debrief form, outlining the study aims and objectives, and support resources for body image and eating concerns. The investigators hypothesize that girls who take part in the Body Confident Athletes intervention will report higher levels of body esteem, sport enjoyment, body appreciation, attuned self-care, resisting objectification, and positive affect and lower levels of negative affect at post-intervention and follow-up, compared to girls who do not take part in the intervention. Note: This research has been approved by the University of the West of England Research Ethics Committee (ref no. HAS.21.03.120) and the University of Minnesota Institutional Review Board (ref no. STUDY00012457).

NCT ID: NCT05380050 Recruiting - PTSD Clinical Trials

Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.

NCT ID: NCT05356234 Recruiting - Intervention Clinical Trials

Ignite Study of the Jewish Family and Children's Service of the Suncoast, Inc.

Ignite
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The goals of the program are to help struggling fathers and father figures improve the parent-child relationship, sustain healthy marriages and relationships (and help those who are single identify ways to enter into safe and supportive relationships that may ultimately lead to marriage), and identify and support fathers in their economic stability and employment objectives. These outcomes will be achieved through a series of workshops addressing responsible parenting and marriage and relationships as well as a complement of employment services and comprehensive case management. Additional services needed by participants will be identified and provided either through wraparound programming provided by JFCS or through collaborative agreements with local partner agencies. Additionally, Ignite will incorporate a comprehensive employment program combining both job and career advancement.

NCT ID: NCT05321342 Recruiting - Intervention Clinical Trials

Coaching Teachers in Bullying Detection and Intervention

BCCU
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

The investigators' overall objective is to demonstrate the efficacy of the Bullying Classroom Check-Up (BCCU) on elementary aged students' aggressive and bullying behaviors, teacher practices, and student and teacher relationships. The investigators' principal hypothesis is that the BCCU will improve students' aggression and bullying behaviors and their perceptions of the school climate and relationships in the building as well as teacher practices.

NCT ID: NCT05299138 Recruiting - Intervention Clinical Trials

Restoring Empowerment and Choosing Hope (REACH)

REACH
Start date: February 17, 2022
Phase: N/A
Study type: Interventional

The goals of REACH are to help adults develop the skills they need to develop healthy relationship and marriage skills, improve ability to parent and co-parent effectively, identify and enhance skills and abilities required to gain or retain economic self-sufficiency, and foster family stability and increase successful marriage rates. Data from the tri-county region comprised of Sarasota, Manatee, and Charlotte counties demonstrates the presence of a number of risk factors affecting family stability, including high rates of single-parent households, births to unwed mothers, and high median rent costs compared to poverty rates and income. By providing families with relationship enhancement, parenting, and economic self-sufficiency services, this should help to optimize each family member's quality of life and improve child well-being.