439 Clinical Trials for Various Conditions
Despite the numerous physical and psychological benefits of taking part in sport, studies consistently show that only 15% of adolescent girls globally meet the recommended daily exercise guidelines (Guthold et al., 2018). The team climate, created by coaches, has been identified as a critical factor in both girls' participation in, and enjoyment of, sport and movement (CITE). Research indicates that girls disengage from sport because of body image concerns, uncomfortable and objectifying uniforms, appearance-related teasing from peers and coaches, untrained coaches, and negative team cultures (Murray et al., 2021; Vani et al., 2021). help coaching girls books as another form of media that produces "commonsense proof" of girls' sport inferiority, essentializes gender differences, reifies the gender binary (Kane, 1995), and marginalizes the sport participation of girls. The beliefs, values and expectations of significant adults can positively or negatively influence self-perceptions, motivation, experiences, and behaviors of children (Fredricks \& Eccles, 2005; Brustad et al., 2001) and also directly influence the coaching behaviors of adults (Cassidy et al., 2005). The 'coaching girls' books examined for this study were formulaic products written from a perspective of difference, "despite extensive evidence from meta-analysis research of gender differences which supports the gender similarity hypothesis" (Hyde, 2005, p.590). ambivalent and primarily non-research based messages contained within the books trivialize, misrepresent, distort, and marginalize girls' emotions, thoughts, relationships, skills and behaviors in sport contexts (Birrell \& Theberge, 1994), while upholding coaching boys as normative praxis. Coaching girls books appear to "help" coaches of female athletes, while simultaneously reifying gender stereotypes that undermine female empowerment that can occur in and through sports. Praxis based on gendered beliefs of inherent difference is dangerous as it can undermine male-female relationships as well as beliefs of equality, and deprive all children of the opportunity to develop their full human potential (Barnett \& Rivers, 2004). Coaches must be aware that coaching is a gendered practice in which beliefs and values are enacted, sometimes in ways that limit the experiences of their athletes. On the other hand, sport participation can improve girls' self perceptions and lead to accrual of health and development assets if the coach and adults in the context are aware of the gendered nature of sport, and strive to eliminate deleterious effects (LaVoi, 2018). This study will test an educational program for coaches aimed at reducing gender essentialist beliefs and gender stereotypes of coaches, to improve the sport experience for girls.
The purpose of this pilot study is to explore the use of a large language model (LLM) in providing education and behavioral health coaching for individuals with Systemic Sclerosis (SSc). The goal of the LLM is to help user set or modify behavioral goals, provide education, or emotional support as needed by the participant. The primary outcome for this study is to assess the feasibility and acceptability of using an AI-supported health coaching tool over a four-week period.
This clinical trial evaluates the effect of life coaching together with Alpha-Stim AID® (Anxiety, Insomnia, Depression), also known as Alpha-Stim®, as an intervention to decrease self-reported symptoms of burnout, moral distress, resilience, and employee retention in oncology healthcare workers. Burnout and moral distress are occupational hazards for oncology healthcare workers. Emotional exhaustion, depersonalization, and lack of personal accomplishment at work are symptoms of burnout. Moral distress may be defined as knowing the right thing to do but being unable to do so based upon internal or external constraints. Alpha-Stim® is a device attached to the earlobes that uses cranial electrotherapy stimulation (CES) at a microcurrent to alleviate symptoms of anxiety, insomnia, pain, and possibly depression. Life coaching is partnering with clients in a thought-provoking and creative process that inspires them to maximize their personal and professional potential and can increase resiliency skills such as boundary setting and prioritizing, increases in self-compassion and self-care, and potentially indirectly positively impact patient care. Undergoing the use of CES via the Alpha-Stim®, coupled with life coaching, may help alleviate burnout symptoms and moral distress in oncology healthcare workers.
The proposed study will test the feasibility and acceptability of enrolling and retaining cancer survivors and their bedroom partners in a study evaluating digitally delivered behavioral sleep interventions.
Naturalistic developmental behavioral interventions (NDBIs) are a newer class of evidence-based interventions for young autistic children to promote their positive developmental or behavioral outcomes. These are often delivered by family members or other natural change agents given the emphasis on naturalistic transactions between an adult and a child. Despite the emerging evidence, there are practical difficulties that hinder wider dissemination and implementation of NDBIs, including low level of access to some of these branded, packaged NDBIs. To mitigate these difficulties related to access, we have created a series of video modules that demonstrate nine commonly used core components in NDBI strategies. In this study, caregivers will receive training and coaching using these modules and both synchronous and asynchronous coaching from a clinician. In this type 1 hybrid implementation trial, there are two groups of participants: (1) caregivers of young autistic children or children with other developmental disabilities/delays, (2) children, and (3) clinicians. Caregivers will meet with clinicians virtually weekly to (a) watch the newly developed NDBI videos that demonstrate the strategy use, (b) discuss how this might be applied to their own child, (c) receive individualized homework planning, (d) record and upload videos of their practice of strategy use with their own child, and (e) review the videos with clinicians to receive individualized feedback on their strategy use. This will occur for 10 weeks. Each session will be video recorded to assess the clinicians' intervention fidelity. After 10 weeks, pre-post tests will be conducted to assess parents' confidence on implementing these strategies, their child's social communication, and satisfaction of providers and caregivers. Qualitative data will also be collected via interviews with some selected participants to gain a deeper understanding of their perceptions.
In individuals with overweight/obesity, increases in physical activity (PA) can improve metabolic and cardiovascular health, independent of weight loss. However, PA levels are often low in individuals with overweight/obesity, and primary care providers (PCPs) are tasked with addressing this issue. The investigative team developed and successfully piloted integrating a Fitbit program into clinical care, where patients were referred by PCPs, and PCPs could view PA data in the Epic electronic health record. Though feasible, PCPs wanted additional support for PA management. The investigative team proposes a reimbursable service of a health coach to work collaboratively with PCPs, to deliver a Fitbit-supported PA program to patients with overweight/obesity who have been prescribed a weight loss medication for weight loss for a minimum of 3 months. In Aim 1, the team will enroll PCPs to refer patients to a 12-week health coaching program. In Aim 2, the team will conduct interviews with enrolled patients/PCPs to understand their perspectives on the program, and with new sites to establish relationships for a future R01 submission.
The goal of this longitudinal study is to investigate the role of virtual health coaching on mitigation of cardiometabolic disease risk in an underserved, food insecure population. The main questions it aims to answer are: * Does longitudinal, individualized health coaching directed at lifestyle modification reduce patient 10-year risk of heart attack or stroke? * Does longitudinal, individualized health coaching directed at lifestyle modification reduce rates of hypertension, hyperlipidemia, and diabetes? * Does longitudinal, individualized health coaching directed at lifestyle modification improve accessibility to healthcare? Researchers will investigate the effects of regularly scheduled health coaching sessions on composite cardiometabolic risk profile as well as individual modifiable cardiovascular risk factors. Participants will: * Participate in in-person cardiovascular screening, occuring at the time of enrollment, months 3 and 6. * Engage in virtual health coaching sessions to talk about diet, exercise, weight loss, blood pressure and diabetes control, and accessibility to healthcare * Keep a log of their blood pressure
This clinical trial evaluates whether a mentorship and education intervention called COACH-APP works to improve advanced practice providers' (APPs) confidence in their ability to participate in clinical research (research self-efficacy). APPs are skilled clinicians who are routinely part of cancer care teams, but who may not routinely be part of the research care team at community oncology sites. The COACH-APP program provides focused education and structured mentorship to assist in meaningful integration to the research care team, which may increase research self-efficacy among APPs and ultimately improve patient care and access to clinical trials.
For patients discharged with a diagnosis of cardiovascular disease coronary artery disease resulting in myocardial infarction and/or congestive heart failure, this study will evaluate if the addition of 12 virtual health coaching sessions over the course of 16 weeks will improve physiological, psychological, and social health outcomes, prove acceptable and satisfactory for these patients with CVD, decrease CVD-related questions and concerns sent to the provider via MyChart, and reduce hospital readmission rates over a 90-day period as compared to patients discharged with the same diagnosis who receive standard post-discharge care. The study will also evaluate the perceptions of physician and advanced practice providers related to the health coach as part of the interprofessional team and the amount of time spent addressing CVD-related patient questions and concerns via MyChart messages.
Our goal is to explore the effectiveness of 9- month lifestyle medicine based coaching intervention (individual and group coaching) versus control (usual care/ written health instructions). The primary study outcomes will be mean changes in body composition metrics . Secondary outcomes will be the prevalence of metabolic abnormities, progression/regression of Metabolic Syndrome, push-up \& sit/stand capacity, self-reported physical activity, and quality of life/diet/sleep measures.
The purpose of this clinical trial is to determine the impact of a home-based pulmonary rehabilitation program with health coaching on patient-reported respiratory-related quality of life and physical activity, as compared to usual care in patients with fibrotic interstitial lung disease.
To learn if coaching participants on diaphragmatic breathing will help participants to take larger, more reproducible breaths and feel less anxiety about their treatments.
Research has shown that for women who are undergoing pelvic radiation therapy, fatigue is a common side effect. Fatigue that occurs during radiation therapy can make it harder to perform daily living activities. While there are studies that recommend exercise as a treatment for fatigue in cancer patients and survivors, there are currently no studies that focus on the role of exercise for women undergoing pelvic radiation therapy. The purpose of this study is to see if incorporating an activity coaching program is helpful in improving treatment-related fatigue for women undergoing pelvic radiation therapy for endometrial cancer.
The goal of this mechanistic clinical trial is to examine whether parent-coaching aimed at increasing child positive affect will increase child neural response to reward. The main questions it aims to answer are: Aim 1. Characterize child neural reward response and its relation to maternal socialization of positive emotions at baseline in healthy young children. Aim 2. Evaluate how coaching-related changes in maternal socialization of positive emotion expression contribute to increases in child neural reward response over time. Aim 3. Examine how maternal socialization of positive emotion expression contributes to increases in child neural reward response in the moment. Participating mother-child dyads will be randomized to either 3 sessions of parent coaching of child positive affect or 3 sessions of a general parenting support intervention and neural response to reward and affective behavior will be examined pre and post intervention.
This study examines the impact of a clinical whole health coaching program aimed at improving Veteran's health and well-being by promoting engagement/adherence with clinical recommendations and increasing healthy lifestyle behaviors in treatment-seeking Veterans receiving care at the DC and CA War Related Illness and Injury Study Centers.
Insufficient sleep is a significant public health issue, particularly affecting shift workers like firefighters, nearly half of whom report short or poor-quality sleep, with 35-40% screening positive for sleep disorders. Cognitive Behavioral Therapy for Insomnia (CBTi) is a recommended and effective treatment, but access to such interventions remains low. This study will recruit 20 fire agencies in Arizona (400 firefighters) to test if a CBTi-informed intervention, including sleep health coaching and agency-wide promotion, improves sleep more effectively than usual care. The trial will also explore factors that influence successful implementation across agencies.
The goal of this clinical trial is to learn if the My Health Coach app helps adults with fetal alcohol spectrum disorders (FASD). The main questions it aims to answer are: Does the My Health Coach app improve the quality of life of adults with FASD? Does the My Health Coach app help adults with FASD manage their day to day life? All participants will be asked to complete 3 sets of surveys: 1) at the study start, 2) at 6 weeks, and 3) at 12 weeks. Half of the participants will be given the app at the study start to use. The other half of participants will get the app after the 12 week surveys are complete. Researchers will compare survey results from people who receive the app right away to those who are in the waitlist group to see if there are changes in quality of life or day to day functioning.
The Icahn School of Medicine at Mount Sinai will conduct a randomized controlled trial of a self-management support intervention for predominantly minoritized and low-income adults with chronic obstructive pulmonary disease (COPD). The trial will focus on comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation and oral steroid and antibiotic prescribing for pre-emptive treatment of COPD exacerbations. The research team will compare this intervention with an attention control group to evaluate the effects on medication adherence, COPD symptoms, inhaler technique, physical activity and exercise capacity at 6 months, and at 12 months to examine sustainability of treatment effects. The research team will also examine hospitalizations and emergency department visits at 12 months. The study will recruit 300 participants from the Mount Sinai Health System in Manhattan, Queens, and Brooklyn, ensuring diverse representation. Health coaches from the VNS Health will deliver the intervention, guided by a detailed training manual. Weekly conference calls will address logistical and protocol-related issues.
The purpose of the present pilot is to evaluate the outcomes of adding a patient coach to support the Optimal Health Weight and Lifestyle (OHWL) Clinic plan developed by PI Dewar, specifically to address barriers and facilitators of adherence to the plan. This will be accomplished via a coach who is not embedded in clinic care and is supported by pilot research funds. Evaluation of the coach activities, conducted by research personnel, will include compiling data from the electronic health record, a short set of patient report and performance measures, and qualitative interviews.
The goal of this randomized controlled study is to learn if, in addition to nurses, community members can be trained as health coaches to deliver the HealthyLifetime (HL) program to people without complex chronic health conditions, an intervention that provides a short-term and effective health coaching intervention delivered through a virtual platform to improve health, resiliency, and independent self-care to participants who are without complex chronic conditions. The main question it aims to answer is: • Can Community Health Coaches achieve the same level of competency and outcome as Nurse Health Coaches in participants without complex chronic conditions?
The study aims to adapt an existing Cultural Structural Humility (CSH) training into a video format for peer recovery coaches (PRCs) and refine an AI-driven texting tool to reinforce the training. After refining these tools using user-centered design, a pilot test will be conducted to assess their impact on the uptake of opioid treatment and social services. The study will also evaluate the feasibility and effectiveness of the intervention to inform future large-scale trials.
Black and Latinx people who use opioids are disproportionately impacted by opioid overdose deaths. The proposed study assesses the efficacy of an open source, multimodal artificial intelligence-driven texting tool combined with peer recovery coach-supported text contact that delivers social services, stigma reduction, health habitus, and patient navigation content addressing social determinants of health to enhance receipt of buprenorphine in primary care among emergency department-enrolled Black / Latinx people who use opioids.
The goal of this clinical trial is to learn how integrating health and wellness coaching (HWC) with Continuous Positive Airway Pressure (CPAP) therapy affects adherence to treatment and overall health outcomes in individuals with obstructive sleep apnea. The main questions it aims to answer are: * Does HWC improve CPAP adherence compared to standard care, in terms of device usage metrics (hours per night and days per month)? * How does combining HWC with weight management influence CPAP adherence and weight loss? * What are the differences in treatment outcomes between individuals receiving standard care and those receiving HWC? Researchers will compare two groups: * Standard Care Group: Participants receiving standard CPAP therapy without additional health coaching. * HWC Group: Participants receiving CPAP therapy combined with health and wellness coaching focused on weight management and sleep hygiene. Participants will: * Attend 2 in-office visits with a study physician (2 hours maximum) * Have 6 virtual visits via video with a study health coach (3 hours maximum) if in the HWC group This study aims to provide valuable insights into enhancing treatment outcomes for individuals with sleep apnea by integrating health coaching with CPAP therapy.
This clinical trial evaluates the impact of telehealth self-management coaching sessions on quality of life in pancreatic cancer survivors and their family care givers (FCGs). Patients with pancreatic cancer experience many symptoms because of the disease and treatment, which can have a negative impact on quality of life. Patients and their families have unmet needs during treatment, including a lack of quality of life programs that offer support to patients. Supporting patients and families on managing the physical symptoms, emotional well-being, social well-being and spiritual well-being with telehealth self-management coaching sessions may help improve quality of life, manage symptoms from treatment, and support families in their role as caregivers during treatment.
The goal of this work is to conduct a randomized trial evaluating the effects of a behavioral intervention to increase sleep duration and quality for adolescents with type 1 diabetes (T1D). The impact of the sleep-promoting intervention on executive function and glycemic outcomes will be assessed. We will also explore multiple components of the recently identified central nervous system glymphatic system and evaluate how these components change and impact brain integrity and function with improved sleep.
The project objective is to rigorously evaluate the effectiveness of a peer recovery coaching intervention (called RC-Link) in patients hospitalized with medical complications from alcohol use on recovery outcomes guided by the new NIAAA definition of recovery, examine mechanisms of heavy drinking using daily ecological momentary assessment (EMA), and determine the program's cost-effectiveness using an randomized controlled trial (RCT) design. The primary outcomes are frequency of heavy drinking, biopsychosocial functioning, and remission from AUD.
This study will test a new cognitive-behavioral skills training program (CBI) delivered in the metaverse. Although initial evidence suggested CBI was feasible for individuals experiencing depression or anxiety, CBI's effectiveness compared to no intervention has yet to be determined. The intervention may be delivered through virtual reality as well as flat-screen devices, such as a computer, which may also affect CBI's effectiveness. The study will enroll up to 306 participants with depression. One third of the participants will access CBI through virtual reality, one third of the participants will access CBI through a flat-screen device, and one third of the participants will be asked not to attend CBI sessions for the first 8 weeks of participation of the trial. For both CBI conditions, treatment will be provided over 8 weeks, with a 6-month follow-up period. Enrollment will be ongoing and groups will occur simultaneously. Potential participants are asked to complete an initial screening and an intake evaluation to determine eligibility. They will then receive 8-weeks of treatment. Participants will complete brief weekly self-report questionnaires throughout their time in the study.
The goal of this two-group randomized trial is to determine the feasibility and acceptability of a remotely-delivered health coaching intervention offered in conjunction with usual care for patients with an acute exacerbation of chronic low back pain who present to the emergency department (ED). The main questions this feasibility trial aims to answer are: * Is our health coaching intervention and randomized trial methodology feasible to conduct? * Is our health coaching intervention acceptable to participants and ED providers? Participants will be randomized to one of two groups (usual ED care plus health coaching or usual ED care plus education) and complete outcome assessments at 3 and 6 months after ED discharge. Participants and ED providers will also complete an interview.
A Decentralized, Double-blinded, Randomized, 18 month, Parallel-group, Superiority Study to evaluate the impact of Complement Theory's Live 1:1 Exercise Coaching and Personalized Digital Application on Cancer Survivors' Cost of Care
The goal of this clinical trial is to examine how a clinic-based school readiness coaching session conducted by a community health worker for parents of 3-5-year-olds affects children's School Readiness (SR) skills and parents early SR knowledge and behaviors. The main questions it aims to answer are: What impact does the clinic-based coaching session have on preschool-aged children's school readiness skills and their parents' confidence in supporting and practicing early math and literacy behaviors at home? Participants will receive a 1-hr coaching session at their pediatric clinic and return after three months for a follow-up session. Researchers will compare pre-and-post child and parent SR outcomes between these two sessions.