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Physical Activity clinical trials

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NCT ID: NCT06381687 Recruiting - Physical Activity Clinical Trials

A Movement and Music Programme in Early Childhood Education and Care (The MoviMusi Study Protocol)

MOVIMUSI
Start date: March 20, 2024
Phase: N/A
Study type: Interventional

The early childhood education and care (ECEC) environment is an important setting for providing children with daily opportunities for movement and music, supporting holistic child development in the early years. To date, there are no studies evaluating the implementation of a holistic programme in the ECEC context in the areas of movement behaviour, motor, and musical skills. The main aim is to examine the impact over time of a holistic movement and music programme on correlates of movement behaviour, gross and fine motor skills, and musical skills in young children (1-3 years). The secondary aims are to examine the impact of the movement and music programme on the perceptions of the educational community, as well as the barriers and facilitators they perceive in the process of baseline assessment, construction, and implementation of the movement and music programme in their own ECEC community. This cluster-randomised controlled trial (intervention and control groups) with public ECEC centres will be performed over a 24-month period. Baseline measurements will be taken in the first year of the project, and the longitudinal evaluation of the implementation of the movement and music programme in the second year. educational community's perceptions about the barriers and facilitators associated with the correlates of movement behaviour will be taken into account, as will the results of the assessment of gross and fine motor and musical skills identified in the first year of the project, with a special focus on the structured and unstructured opportunities for movement and music both in the ECEC settings and at home. This research project aims to fill a knowledge gap during a period of childhood that has rarely been explored, either nationally or internationally (1-3 years), and to position movement and music teaching practices as key contexts in the curriculum development of infant and toddler education.

NCT ID: NCT06377306 Recruiting - Physical Activity Clinical Trials

Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes

Start date: November 5, 2023
Phase:
Study type: Observational

Despite a rise in the number of women participating in competitive sports, there remains a gender gap within sport and exercise science literature. Studying females involves potential "noise" through the change in hormone concentrations during the different phases of the female menstrual cycle (MC) which can potentially affect physiological parameters, thereby making study design and interpretation of findings difficult. Longitudinal data on the acute and chronic combined effects of training load and MC phases on circulating female hormones in elite and non-elite female athletes is lacking. The investigators aim to characterize and track the potential effects of training load and MC phases on performance, anthropometric measures, sport emotions, intestinal microbiome, serum metabolites and injury prevalence in elite and non-elite female athletes. 200 competitive premenopausal female athletes will be recruited. In a longitudinal observational design, each participant will be followed for 1 year, and tested at three time points. At each point, data will be collected on two occasions reflecting distinct phases of the MC. Finding the possible relationship between the MC phases, training load and performance or specific bio-markers for training load are of utmost importance and can assist professionals to identify periods of high load and over-training, thus preventing injuries and training adjustment.

NCT ID: NCT06367439 Recruiting - Physical Activity Clinical Trials

Examining the Effects of Virtual Reality Exercise on Mental Health

UVIC VR Fit
Start date: March 19, 2024
Phase: N/A
Study type: Interventional

The primary purpose of this investigation is to examine the effectiveness of virtual reality (VR) exercise (Supernatural exergaming via Meta Platforms Technologies, LLC) for improving mental health as indicated by (1) both short-term mood (one exercise bout) and long-term (10-weeks) mood (depression and anxiety symptoms), (2) well-being (i.e., vitality) over a 10-week period, and (3) perceived cognitive function over a 10-week period. The secondary purpose of this study is to examine the effectiveness of VR exercise for improving both physical activity behaviour and physical activity motivation (attitudes, capability, opportunity, behavioural regulation, habit, identity) over a 10-week period. The tertiary purpose is to examine whether key motivational variables (e.g., attitudes, capability, opportunity, behavioural regulation, habit, identity) regarding Supernatural use explain variability in Supernatural use over time.

NCT ID: NCT06350877 Recruiting - Physical Activity Clinical Trials

1:1 and Group-based Exercise Intervention for Post-secondary Student Mental Health and Well-being

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Post-secondary students report alarming rates of feeling overwhelmed, hopeless, anxious, and depressed. To better support student mental health, there is a well-documented need to improve the range and quality of mental health services available to students. Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed. Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses. Despite the growing evidence supporting physical activity for student mental health, there are significant knowledge gaps in the literature. First, there is a paucity of research exploring the effects of different delivery styles (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress) and secondary (i.e., social support, social connectedness) outcomes. Secondly, the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown. Lastly, limited research has explored contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may influence the sustainability and scale-up of physical activity programs for student mental health. Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice. The goal of this 3-arm parallel randomized controlled trial is to test the effectiveness of 1:1 physical activity intervention and group-based physical activity intervention compared to a wait-list control group in supporting post-secondary student mental health. The main questions include: - Are there group differences between 1:1, group-based delivery, and waitlist control in the immediate (post-intervention) and follow-up (1-month) maintenance effects on the primary and secondary outcomes? - Grounded in recommendations for process evaluation of complex interventions, what are contextual implementation factors that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination? Trial participants will be randomly assigned to one of the following groups: 1. 1:1 physical activity training; 2. Group-based physical activity training consisting of small 5-8 person groups; or 3. Waitlist control. Students will participate in the physical activity intervention after the intervention and follow-up period (10 weeks); however, their participation will not be monitored or evaluated. The physical activity training will involve a 6-week physical activity intervention consisting of weekly 1-hour sessions. Each session involves: (1) 30-minutes of behaviour change coaching (e.g., goal setting, action-planning, brainstorming strategies to overcome barriers to engaging in physical activity); and (2) 30-minutes of supervised and structured physical activity training. To address the aims of the study, participants will complete self-report questionnaires at baseline, post-intervention (following completion of the 6-week physical activity intervention), and 1-month following completion of the physical activity intervention. Questionnaires will assess demographic characteristics, primary outcomes (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress), secondary outcomes (i.e., social support, social connectedness, physical activity behaviour) and contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination. It is hypothesized that there will be no group differences between 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes. Lastly, it is hypothesized that in comparison to the control group, 1:1 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes.

NCT ID: NCT06337708 Recruiting - Diabetes Mellitus Clinical Trials

Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women

Start date: January 19, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women.

NCT ID: NCT06260579 Recruiting - Physical Activity Clinical Trials

Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity

PHOENIX-Kidney
Start date: November 14, 2022
Phase: N/A
Study type: Interventional

This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent.

NCT ID: NCT06254638 Recruiting - Physical Activity Clinical Trials

Effectiveness of a Multicomponent Intervention to Promote Physical Activity Levels During the School Day (MOVESCHOOL)

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

Study based a multicomponent school-based intervention during the school-day (i.e., Physically active learning, active breaks, and active recess) on Physical Activity, health, educational, and cognition outcomes in adolescents.

NCT ID: NCT06181162 Recruiting - Physical Activity Clinical Trials

YoPA - A Youth-centred Participatory Action

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

Background A vast majority of adolescents do not meet guidelines for healthy physical activity, sedentary behaviour, and sleep, posing major risks for developing multiple non-communicable diseases. Unhealthy lifestyles seem more prevalent in urban than rural areas, with the neighbourhood environment as a mediating pathway linking urban living and poor health. How to develop and implement sustainable and effective interventions focused on adolescent health and wellbeing in urban vulnerable life situations is a key challenge and research gap. This paper describes the protocol of a Youth-centred Participatory Action (YoPA) project aiming to tailor, implement, and evaluate social and physical environmental interventions using an evidence-informed youth-centred co-creation approach, for structural improvement of the lifestyles of adolescents in urban vulnerable life situations. Methods In diverse urban environments in Denmark, the Netherlands, Nigeria, and South Africa, academic researchers will engage adolescents (12-19 years) growing up in vulnerable life situations and other key stakeholders (e.g., policy makers, urban planners, community leaders) in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will take a leading role in mapping the local system for needs and opportunities; tailoring interventions to their local context; implementing and evaluating interventions during participatory meetings over the course of three years. YoPA applies a participatory mixed methods design guided by the newly developed SUPER-AIM framework assessing: (i) the local Systems, (ii) User perspectives, (iii) the Participatory co-creation process, (ii) Effects, iv) Reach, (vi) Adoption, (vii) Implementation, and (viii) Maintenance of interventions, in an integrated manner. Discussion YoPA aims to fill various research gaps, including the development of a practical protocol guiding the application of co-creation to tailor evidence-informed interventions to divers, multi-country contexts. Additionally, it focuses on advancing the research gap in physical activity and health within Sub-Saharan Africa and the involvement of adolescents in shaping their physical and social environments. Academic researchers envision that the YoPA co-creation approach will serve as a guide for participation of adolescents in vulnerable life situations in implementation of health promotion and urban planning in Europe, Africa and globally.

NCT ID: NCT06171945 Recruiting - Obesity Clinical Trials

Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors

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

The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of theory-based mobile weight loss interventions for survivors of adolescent and young adult cancer (AYAs). The interventions use a mobile smartphone application, previously developed for individuals at risk for type 2 diabetes and adapted for AYAs, that integrates weight and physical activity from digital devices with simplified dietary monitoring in a behavioral weight loss program.

NCT ID: NCT06125704 Recruiting - Physical Activity Clinical Trials

Time to Move in Pregnancy Hyperglycemia

TtM
Start date: December 6, 2023
Phase: N/A
Study type: Interventional

This randomized controlled crossover trial of 36 pregnant individuals with gestational diabetes (GDM) or gestational glucose intolerance (GGI) will: 1. Determine the effects of physical activity (PA) timing, specifically 30 minutes of moderate intensity walking or stepping in the morning (between 5am-9am, within 30-40 minutes of starting breakfast), versus late afternoon/evening (between 4pm-8pm, within 30-40 minutes of dinner) on glucose across the 24-hour cycle. 2. Explore the potential effects of the timing of PA on sleep and mood state.