[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Drexel University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":435},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,47,68,94,116,148,173,200,226,247,269,302,330,353,381,406],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100594696","tele-exercise-to-promote-empowered-movement-in-individuals-with-spinal-cord-injury-100594696",false,"NCT07022808","Tele-Exercise to Promote Empowered Movement in Individuals With Spinal Cord Injury","Tele-Exercise to Promote Empowered Movement in Individuals With Spinal Cord Injury, TEEMS","TEEMS","Inclusion Criteria:\n\n1. at least 12 months post SCI (motor spinal level C5 or below)\n2. between 18-75 years of age\n3. ability to elevate shoulders \\>25% range\n4. use assistive technology for mobility\n5. not currently receiving structured rehabilitation (i.e. new episode of inpatient or outpatient rehabilitation services to treat a new or exacerbated mobility issue. Individuals attending outpatient services for ongoing wellness reasons are eligible to participate).\n6. screened and medically cleared (if appropriate) for participation using the American College of Sports Medicine (ACSM) Preparticipation Health Screening Tool. The ACSM Health Screen helps to determine if an individuals should seek a medical referral prior to participation in exercise. The guideline for the screening are based on (1) current exercise participation, (2) history and symptoms of cardiovascular, metabolic, or renal disease, and (3) desired exercise intensity. The algorithm is based on risk stratification and minimizing the barriers of exercise participation by decreasing the number of unnecessary medical referrals.\n\n   For this study and the safety of participants, those who need a medical referral based on the ACSM preparticipation health screen will be required to provide documentation of medical clearance from their primary medical provider prior to study participation. Dr. York will review screening information and medical clearances to ensure safe inclusion.\n7. internet access to attend synchronous exercise classes\n\nExclusion Criteria:\n\n1. Known or suggestive cardiovascular, metabolic, and\u002For renal disease and\u002For presence of absolute or relative contraindications to exercise participation that is considered unsafe by their medical team\n2. self-report previous hospitalization within a month,\n3. self report active pressure injury\n4. self report recent osteoporotic fracture\n5. self-report uncorrectable vision loss,\n6. self-report preexisting neurological conditions other than SCI","ALL","18 Years","75 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"NA","To achieve our specific aims and hypotheses we will conduct a parallel group mixed methods randomized control trial comparing participation in the TEEMS program with exercise via asynchronous video library equivalent (control). The use of mixed methods will allow for the integration of quantitative findings with the qualitative, lived perspective of participants to provide a comprehensive analysis of the tele-exercise program outcomes. All aspects of the study from recruitment, screening, data collection, tele-exercise delivery and team meetings will be virtual to promote access and inclusion by removing barriers and promoting engagement. This study will compare our live group TEEMS program with individual pre-recorded exercise videos. We created TEEMS with the intention of maximizing exercise independence for participants, which decreases need for caregivers during physical activity. The design and participation in TEEMS is meant to increase personal factors that facilitate participation in exercise. These personal factors include confidence and positive associations with exercise. When these personal factors are targeted, individuals with SCI are more likely to participate in physical activity, which supports overall health and QoL.",[28],"Spinal Cord Injury",[30,31,32,33],"randomized control trial","spinal cord injury","physical activity","tele-exercise","RECRUITING","2026-06-01",{"date":37,"type":38},"2026-06-03","ACTUAL",{"date":40,"type":38},"2026-05-04",{"date":42,"type":22},"2029-08-31",{"name":44,"class":45},"Drexel University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":46},"100569140","improving-heart-health-in-individuals-with-sci-using-home-based-virtual-gaming-100569140","NCT06690372","Improving Heart Health in Individuals With SCI Using Home-Based Virtual Gaming","Improving Cardiometabolic Health in Individuals With SCI Using Home-Based Interactive Virtual Gaming","Inclusion Criteria:\n\n* be low risk for developing a cardiovascular event during vigorous exercise according to ACSM\n* be at least 18 years of age;•\n* ASIA level A-D;\n* wheelchair use for at least 75% of community mobility (non-ambulatory);\n* report low amounts of physical activity as determined by the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD). Participants whose combined scores for item 3 (moderate sport or recreation) and 4 (strenuous sport or recreation) ≤10 MET hours per week, will be considered physically inactive.\n\nExclusion Criteria:\n\n* consistent or activity-exacerbated upper extremity pain of at least 4\u002F10;\n* angina or myocardial infarction within the last year, or other major barriers to upper-extremity exercise;\n* inability to elevate arms above 45°,\n* significant spasticity\n* complete upper extremity impairment.",{"count":5,"type":22},[25],"What is the ultimate applicability of the research? Individuals with SCI face several challenges when trying to engage in exercise following injury. Barriers to engagement include cost, transportation, and lack of SCI accessible resources. At the same time, individuals with SCI are at risk of developing negative health consequences (e.g., cardiovascular disease) associated with physical inactivity. A critical need exists to improve relevant, accessible, and sustainable home-based exercise interventions for individuals with SCI to lower the risk of developing secondary comorbid diseases from physical inactivity and to promote wellness. This research will investigate a fun and novel in-home virtual reality system aimed toward improving physical fitness of individuals SCI with the ultimate goal of improving physical, emotional, and psychosocial quality of life. Virtual reality gaming has been used for a long time to improve physical fitness, but there have yet to be virtual reality games designed specifically for individuals with SCI. The explicit aim of this research is therefore to develop a therapeutic technology that will be widely accessible to individuals with SCI.\n\nWhat persons with SCI and\u002For their caregivers will it help, and how will it help them? We aim to provide a readily available exercise platform for individuals with SCI, across a spectrum of physical function. Research has shown that individuals with SCI are particularly prone to be physically inactive. The consequences of physical inactivity have been well documented and include negative outcomes in physical, psychological, and social health with reduced quality of life. For the current study, we will refine our existing virtual reality exercise platform, VR-Move with a focus on non ambulatory individuals with bilaterally preserved C6 function. Our focus on using the exercise platform for this cohort of the SCI population is meant to provide a basis for developing and catering to the platform for higher levels of SCI injury (higher quadriplegic). From our previous work with virtual reality interventions in SCI, we recognize that this product can be widely used by individuals across the age spectrum independently of their home environment.\n\nWhat are the potential clinical applications, benefits, and risks? The proposed virtual reality exercise platform, VR-Move, is intended to provide one of the few accessible exercise modalities designed specifically for individuals with SCI and is readily adaptable across the clinical spectrum - including clinic and self-guided home use. There are no known risks associated with this research.\n\nHow will the pilot clinical trial advance the research findings along the translational spectrum? This project aims to refine and assess timely therapeutic technology with the specific intention of translating study findings into a clinically validated, widely accessible health product that can be deployed and implemented within the home. The project likewise demonstrates collaboration between academia, industry (a veteran-owned business), and veteran SCI communities. Project completion will offer initial validation of a novel health promoting modality (i.e., virtual reality exercise) informed by individuals living with SCI and experts in SCI to be relevant and responsive to specific health\u002Fexercise needs of persons living with SCI. Larger clinical trial testing will subsequently inform product commercialization and dissemination. The resulting platform, developed for unattended in-home use, is expected to make a meaningful contribution to SCI health and physical fitness, accessibility, and quality of life.\n\nWhat is the projected time it may take to achieve a person-related outcome? The team is purposefully refining the existing exercise platform, VR-Move, so that it can be easily implemented within people's homes or in clinic settings. Pending findings from the pilot clinical study, this exercise platform would be available immediately to individuals with SCI\n\nWhat are the likely contributions of the proposed research project to advancing the field of SCI research, patient care, and\u002For quality of life? The proposed study may make significant contributions across several areas. First, it will facilitate fruitful clinical data and basic lines of scientific inquiry regarding the application of the physical activity paradigm. The study will also increase our knowledge regarding the importance of consumer advocate-driven research for individuals with SCI. Second, low-activity following SCI is consistently associated with reduced quality of life among individuals with SCI and their families; access to an inexpensive portable intervention will therefore significantly improve quality of life among those affected by low-activity SCI.",[58],"Spinal Cord Injuries (SCI)",[31,60,61,32],"cardiometabolic risk","virtual reality exercise",{"date":37,"type":38},{"date":64,"type":22},"2026-07-01",{"date":66,"type":22},"2027-08-31",{"name":44,"class":45},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":46},"100551893","unityphilly-response-app-for-overdose-reversal-100551893","NCT06466005","UnityPhilly Response App for Overdose Reversal","UnityPhilly Response App for Overdose Reversal: Assessing Citywide Effectiveness and Sustainability","Inclusion Criteria:\n\n* owning a smartphone with a data package;\n* living or working in one of three identified Philadelphia neighborhoods;\n* aged 18 or older.\n\nExclusion Criteria:\n\n* persons aged under 18 years of age",true,{"count":77,"type":22},450,"OBSERVATIONAL","The goal of this clinical trial is to discover if an overdose prevention app (UnityPhilly) can encourage citizen responders to respond and prevent opioid overdoses using the UnityPhilly app. The main hypotheses to answer are:\n\nHypothesis 1: UnityPhilly signal rates relative to EMS calls will increase over time. The primary outcome will be assessed as the total number of overdoses signaled by participants relative to all overdose-related EMS calls, per year.\n\nHypothesis 2: The number of cases where a nearby UnityPhilly participant successfully reverses an overdose with naloxone will increase over time. The primary outcome will be assessed as the number of successful reversals relative to the total number of responder arrivals, per year.\n\nParticipants will be supplied with the UnityPhilly app, training on how to use the app and respond to an opioid overdose using naloxone, and respond to follow up surveys about their experiences.",[81],"Opioid Overdose",[83,84,85],"overdose prevention","Philadelphia","UnityPhilly","2026-05-07",{"date":88,"type":38},"2026-05-12",{"date":90,"type":38},"2025-09-16",{"date":92,"type":22},"2028-07",{"name":44,"class":45},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":75,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":46},"100610307","eatwell-clinical-trial-r01-100610307","NCT07225881","Eatwell Clinical Trial (R01)","Efficacy of a Multi-level Intervention Designed to Promote Adherence to WCRF\u002FAICR Dietary Guidelines for Cancer Prevention","Inclusion Criteria:\n\n* Age 18 or older\n* Access to technology necessary to receive emails and join videoconferencing meetings\n* Ability to read and speak English\n* Willingness to be randomized to either study condition, including ability and willingness to attend intervention sessions\n* Ability and willingness to attend intervention sessions, receive monthly email messages, and serve in support role if index participant in household is assigned to Eatwell condition\n* Able and willing to visit a commercial laboratory partnered with this project (e.g., Labcorp) in order to have their blood drawn at the time of study visits\n* Low adherence to WCRF\u002FAICR's four dietary guidelines (operationalized as a level of intake, based on brief self-report questions administered during phone screening, that corresponds to a score of 2 or less in the Shams-White method of dietary adherence scoring)\n* Share a household (i.e., a private residence with a shared living space, including kitchen) with an adult who provides informed consent, meets eligibility criteria, and anticipates remaining in this household for the majority of the next 18 months\n* Agree that they will not join another intervention study run by this study team in the next 18 months\n* Successful completion by self and household member of all enrollment and baseline data collection tasks\n* Have an email that they regularly check and willingness to use that for corresponding to study staff\n* Weight at baseline of 396 lbs or less, as the digital scales used for measurement are not able to obtain measurements for weights higher than this\n\nExclusion Criteria:\n\n* A medical or psychiatric condition, including self-reported history of anorexia nervosa or bulimia nervosa, that may limit appropriateness of or ability to comply with dietary recommendations\n* A psychiatric condition, including self-reported history of anorexia nervosa or bulimia nervosa, that may make it difficult or inappropriate for household member to serve in support role\n* Currently taking medication that can substantively change appetite or eating behavior, including using of a GLP-1 medication\n* Planning to enroll in another lifestyle modification program in the next 18 months\n* History of bariatric surgery\n* Currently pregnant or planning to become pregnant in the next 18 months\n* Type 1 Diabetes",{"count":102,"type":22},472,[25],"Cancer is a leading cause of death and will affect many people in their lifetimes. Organizations such as the American Cancer Society and the World Cancer Research Fund\u002FAmerican Institute for Cancer Research (WCRF\u002FAICR) have noted that dietary quality is a key factor influencing cancer risk, but most Americans do not meet these dietary guidelines for cancer prevention. The proposed study will enroll adults from the community (n=236 index participants, 236 household members; N = 472) who have low adherence to WCRF\u002FAICR's four dietary guidelines. Participants will be randomized to either nutrition education or the Eatwell intervention. The Eatwell intervention content is focused on helping participants make healthier grocery shopping decisions, eat at home more often to take advantage of the optimal defaults present there, and learn how to navigate temptation when eating away from home. The findings will be relevant not only to the field of cancer prevention, but to the prevention of other diseases for which dietary quality is important.",[106,107],"Cancer Prevention","Dietary Guidelines","2026-03-13",{"date":110,"type":38},"2026-03-16",{"date":112,"type":38},"2026-02-10",{"date":114,"type":22},"2030-04-30",{"name":44,"class":45},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":46},"100627920","from-kitchen-to-clinic-100627920","NCT07454902","From Kitchen to Clinic","From Kitchen to Clinic: A Family-Centered, Food-As-Medicine Approach Using Medically Tailored Meals and Caregiver Coaching in Pediatric Oncology Care","Patient Inclusion Criteria:\n\n1. Receiving cancer treatment for any cancer diagnosis\n2. Within the first 3-6 weeks of diagnosis i. Diagnosis date is defined as the date of the family meeting relaying diagnosis to the patient\u002Fcaregiver\u002Ffamily\n3. At least 5-21 years of age at the time of enrollment\n4. English-speaking\n5. Approved to participate by both their oncologist and RDN\n6. Must anticipate to live in the same household as the designated caregiver for the duration of the study\n\nPatient Exclusion Criteria:\n\n1. Experiencing swallowing or digestive diseases\u002Ffood allergies (e.g. celiacs, lactose intolerance, nut allergy), or specific food preferences that cannot be accommodated by MANNA.\n2. Receiving nutrition via nasogastric or gastric tube feedings\n3. Bone marrow transplant patient","5 Years","21 Years",{"count":126,"type":22},120,[25],"Children receiving cancer treatment often experience nutrition-related challenges, such as changes in appetite, weight, and food intake, due to treatment side effects and the demands placed on families during care. These challenges can increase caregiver stress, reduce diet quality, and contribute to short- and long-term health risks for children. While medically tailored meals have been shown to improve nutrition and reduce burden in adults with serious illness, their use in pediatric cancer care has not been well studied. This pilot study will evaluate the feasibility and acceptability of a 12-week, family-centered food-as-medicine program for children undergoing active cancer treatment and their caregivers. The program combines weekly delivery of medically tailored meals with individualized caregiver coaching provided by registered dietitian nutritionists. During the first eight weeks, families receive full meal support and weekly coaching sessions, followed by a four-week transition period with tapered meal delivery and bi-weekly coaching to support sustainable nutrition practices. A total of 60 pediatric patients and their caregivers will be enrolled at the Children's Hospital of Philadelphia. The study will assess whether families can be successfully recruited and retained, whether they are able to participate in study activities, and whether the program is acceptable and usable during cancer treatment. The study will also explore preliminary effects on children's dietary intake, weight and growth patterns, treatment tolerance, household nutrition security, and caregiver stress and burden.",[130,131,132],"Pediatric Cancer","Malnutrition, Child","Caregiver Burden",[134,135,136,137,138],"Pediatric oncology","Nutrition intervention","Medically tailored meals","Feasibility studies","Caregivers","NOT_YET_RECRUITING","2026-03-05",{"date":142,"type":38},"2026-03-09",{"date":144,"type":22},"2026-03",{"date":146,"type":22},"2028-12",{"name":44,"class":45},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":46},"100599225","opt-in-early-intervention-program-for-children-waiting-to-receive-an-autism-diagnosis-100599225","NCT07081724","\"Opt-In\" Early Intervention Program for Children Waiting to Receive an Autism Diagnosis","Opt In - Implementation and Evaluation of an Early Intervention Program for Children Waiting to Receive an Autism Diagnosis","Inclusion Criteria:\n\n* age between 16-48 months,\n* parental consent\n* being on a waitlist to receive a formal diagnostic evaluation at the time of parent consent due to autism concerns\n* parents speak English\n* an initial score of 8 or greater or Follow-Up score of 2 or greater on the Modified Checklist for Autism in Toddlers, Revised, with Follow-Up (M-CHAT-R\u002FF; Robins et al., 2014) as an indication of autism likelihood.\n\nExclusion Criteria:\n\n* having already received a formal diagnosis of autism\n* enrollment in early intervention programs delivering more than 5 h per week of evidence-based autism-specific interventions at the time of consent\n* child has a gestational age less than 36 weeks associated with a birth weight less than 2500 g\n* the child is not yet walking, or has severe hearing and\u002For vision impairment that is uncorrected with aids, or known neurological disorder or genetic syndrome (e.g., Down syndrome).","16 Months","48 Months",{"count":126,"type":22},[25],"A growing body of literature documents the benefits of parent-mediated interventions for autism starting early in life . However, the median age of diagnosis in the US continues to be 49 months. Even following formal diagnosis, services often do not begin for another 9 months on average. Such harmful delays in accessing autism-specific early interventions are potentially avoidable, as caregivers of children later diagnosed with autism identify concerns about their child's development by 13 months on average - including difficulties that can be successfully addressed through evidence-based intervention practices. Wait times to receive a formal diagnosis of autism are such a significant barrier that they have been referred to as a \"crisis\" in the field, with parents reporting an average wait time of 1.2 years in the US. The current proposal focuses on circumventing the roadblock of delayed access to diagnosis and intervention by empowering caregivers to address their children's needs before a diagnosis is established.\n\nThis will be accomplished through the implementation and evaluation of the \"Online Parent Training in Early Behavioral Intervention (OPT-In-Early)\", a self-directed online resource for caregivers of autistic children which will be made available during their enrollment in waitlists for a diagnostic evaluation. Key features of OPT-In-Early include: (a) a comprehensive scope (i.e., multiple developmental domains are addressed), (b) a focus on evidence-based Naturalistic Developmental Behavioral Intervention strategies, (c) a combination of required and optional modules, so that caregivers can focus on areas most relevant to their child's needs, and (d) access to online materials designed for self-directed implementation, as well as access to remote consultation with a clinician for advice, clarification and support (including on selection of appropriate modules).\n\nFollowing an alternative approach to the current \"parental concerns - then enrollment in waitlist - then clinical diagnosis - then intervention\", the program is designed to counteract the harmful and frustrating inaction that characterizes the waitlist time with timely action designed to address areas of concern that caregivers have already identified and should be empowered to address. This has the potential to capitalize on the window of opportunity of early brain plasticity, thus maximizing outcomes, and to reduce the anxiety associated with the lack of services that characterizes the period of \"passive waiting\" for a formal diagnosis. To evaluate the utility of this innovative resource, the following specific aims will be addressed:\n\n1. Comparing outcomes for 120 toddlers aged 16-48 months whose caregivers are on a waitlist to receive a formal autism diagnosis, randomly assigned to receive either OPT-In-Early or no intervention during a six-month period. The investigators predict that (a) children randomized to the OPT-In-Early condition will have superior gains as reflected in the Goal Attainment Scaling, changes in adaptive behavior and social communication standardized measures, and (b) their families will experience superior improvements in their well-being.\n2. Examining implementation outcomes of feasibility and acceptability of the intervention. The investigators predict high acceptability and feasibility for the OPT-In-Early content and format, as indicated by end-users' responses to standardized measures reflecting 80%+ agreement on the feasibility and acceptability of the program.\n3. As an exploratory aim, investigators will examine theoretically- and empirically- motivated factors associated with intervention uptake and child outcomes, including demographic profiles and child clinical presentation.\n\nExamining whether accessing and using OPT-In-Early during waitlist time is a viable alternative to the current \"first diagnosis then intervention\" format (for all children, or for children with specific profiles and needs) is a critical step toward promoting a more efficient intervention delivery model, bridging the gap between onset of parental concerns and availability of intervention practices designed to target such concerns.",[161],"Autism",[163,164],"randomized controlled trial","autism early intervention","2026-01-27",{"date":167,"type":38},"2026-01-28",{"date":169,"type":38},"2025-08-25",{"date":171,"type":22},"2029-12",{"name":44,"class":45},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":46},"100610084","social-groups-for-autistic-young-adults-sdariya-100610084","NCT07222982","Social Groups for Autistic Young Adults (SDARIYA)","Social Groups for Autistic Young Adults (SDARI)","SDARIYA","Inclusion Criteria:\n\n* Have graduated from high school (or an equivalent program) and are between the ages of 18-30 years old\n* Demonstrate the ability to complete consent and all study measures and procedures in English\n* Score ≥ 65 on the RAADS\n* Score ≥ 70 on the KBIT-2R\n* Score ≥ 6 on the ADOS-2 Module 4\n* Are physically able to complete study activities (e.g., no significant physical impairment or mental condition restricting participation in study activities).\n* Are physically able to travel to the AJ Drexel Autism Institute at Drexel University in Philadelphia, PA to attend all weekly study sessions\n\nExclusion Criteria:\n\n* Are still enrolled in high school (or an equivalent program) or are not between the ages of 18-30 years old\n* Are unable to complete study measures and\u002For procedures in English\n* Are unable to complete consent procedures\n* Score ≤ 65 on the RAADS\n* Score ≤ 70 on the KBIT-2R\n* Score ≤ 6 on the ADOS-2\n* Cannot physically complete study activities\n* Cannot physically travel to the AJ Drexel Autism Institute at Drexel University in Philadelphia, PA to attend study sessions\n* Have a severe medical or psychiatric condition preventing them from safely completing study activities","30 Years",{"count":183,"type":22},54,[25],"This is a clinical trial that will test whether a group program called SDARI (Socio-dramatic Affective Relational Intervention) can help autistic young adults between the ages of 18 and 30 feel more connected to others and improve their social relationships.\n\nThe study will try to answer:\n\nCan SDARI be used successfully with autistic adults? Does SDARI help people feel more connected, supported, and mentally well?\n\nThere are two groups in the study. One group will participate in the SDARI program, and the other group will do different structured activities that don't focus on social connection. Researchers will compare the two groups to see if SDARI leads to better outcomes.\n\nParticipants will:\n\nComplete screening to confirm eligibility (including autism traits and IQ) Attend weekly in-person group sessions for 10 weeks Take part in games and activities designed to support connection and collaboration Complete surveys and interviews before, during, and after the program Have the option to choose someone close to them (like a friend or family member) to fill out surveys about their experiences",[187],"Autism Spectrum Disorder",[189,190,191],"autism","intervention","social performance","2025-10-29",{"date":194,"type":38},"2025-10-31",{"date":196,"type":22},"2026-01-15",{"date":198,"type":22},"2031-02",{"name":44,"class":45},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":75,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":46},"100605669","centering-autistic-perspectives-in-behavioral-intervention-discussions-100605669","NCT07165522","Centering Autistic Perspectives in Behavioral Intervention Discussions","Adapting and Testing a Novel Method of Engagement in Research: Centering Autistic Perspectives in Behavioral Intervention Discussions","CAPBID SoE","Inclusion Criteria:\n\n1. Adults over the age of 18\n2. Individuals who have had experience with Applied Behavior Analysis (ABA) at any time in their lives who is:\n\n   1. An Autistic individual who experienced Applied Behavior Analysis or\n   2. A practitioner who currently or previously was involved in the delivery of Applied Behavior Analysis\n3. Able to communicate fluently in English\n4. Individuals who do not report the endpoint values on the AAPS:\n\n   1. ABA should never be used for autistic people\n   2. ABA is the only evidence-based intervention for autism\n\nExclusion Criteria:\n\n1. Under the age of 18,\n2. Unable to communicate in English",{"count":21,"type":22},[25],"The Centering Autistic Perspectives for Behavioral Interventions Discussions (CAPBID) PCORI Science of Engagement Award will examine different community engagement approaches for bringing together autistic people, Applied Behavioral Analysis (ABA) providers, and other members of the autism community to advance a shared equitable dialogue around research priorities for ABA-related research. One of these approaches will be based on existing transformative and restorative justice methods and frameworks. This project also utilizes a community-driven participatory research approach that will center autistic leadership in all aspects of the project.\n\nThe investigators hope that this research will pave the way for creating spaces where autistic people are heard in their experiences and can collaborate effectively with open-minded ABA providers about how to advance the next generation of care and research in the field. More broadly, the investigators aim to create engagement approaches that may be used to have conversations around critical and difficult issues faced by the autistic and autism communities, as well as other marginalized communities.",[161],[161,213,214,215,216,217],"Applied Behavior Analysis","ABA","Community Based Participatory Research","Transformative and Restorative Justice","Engagement","2025-09-07",{"date":220,"type":38},"2025-09-10",{"date":222,"type":22},"2026-03-15",{"date":224,"type":22},"2028-02-15",{"name":44,"class":45},{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":75,"sex":17,"minAge":18,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":46},"100504991","real-time-fmri-for-insular-cortex-brain-state-triggered-experience-sampling-100504991","NCT05855525","Real-time fMRI for Insular Cortex Brain State-triggered Experience Sampling","Inclusion Criteria:\n\n* Age between 18-35\n\nExclusion Criteria:\n\n* History of psychiatric or neurological disorder\n* contraindication for MRI","35 Years",{"count":234,"type":22},60,[25],"In a neuroimaging session, study participants will repeatedly and intermittently report the content of their ongoing, self-generated experiences based on an experience-sampling protocol in which self-report ratings will be triggered based on real-time analysis of the participant's current brain state. The protocol will be conducted while participants are undergoing MRI scanning.",[238],"Healthy","2025-08-18",{"date":241,"type":38},"2025-08-22",{"date":243,"type":38},"2024-02-15",{"date":245,"type":22},"2025-11-30",{"name":44,"class":45},{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":181,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":268},"100582427","cigarillo-public-education-messaging-for-black-young-adults-100582427","NCT06863168","Cigarillo Public Education Messaging for Black Young Adults","Effective Cigarillo Public Education Messaging for Black Young Adults","Inclusion Criteria:\n\n* Be between 18 to 30 years of age;\n* Self-identify as non-Hispanic Black or African American ethnicity and race, respectively;\n* Must be able to communicate, read, and write in the English language;\n* Have never used cigarillos fairly regularly based on a valid measure but are deemed susceptible to cigarillo smoking based on a valid 4-item susceptibility measure; OR currently smokes cigarillos some days but not every day (i.e., experimentation)\n* And must have no history of fairly regular use of any other tobacco products (i.e., little cigars, large cigars, cigarettes, hookah tobacco, electronic vaping products, smokeless tobacco, and heated tobacco products)\n\nExclusion Criteria:\n\n* Persons who are younger than 18 years of age or older than 30 years of age.\n* Persons who do not self-identify as a non-Hispanic Black\u002FAfrican American person.\n* Persons who are not deemed susceptible based on a valid susceptibility measure (i.e., not susceptible to cigarillo smoking)\n* Persons who have fairly regular use of any tobacco product (i.e., persons with a former or current established pattern of any tobacco use including cigarillos, little cigars, large cigars, cigarettes, hookah tobacco, electronic vaping products, smokeless tobacco, and heated tobacco products)\n* Persons who are unable to read, write, and communicate in English language. The informed consent and other materials, including surveys, are only available in the English language for this study. Additionally, trained staff members that will communicate and interact with participants for this study can only speak in English.",{"count":255,"type":22},360,[25],"This is a 3-arm randomized controlled trial to examine the effects of cigarillo public education messages among Black young adults who are at-risk for established cigarillo smoking. The primary outcomes are cigarillo harm perceptions, outcome expectancies, and use intentions at 3-month follow-up. Exploratory outcomes are use behaviors (cigarillo smoking initiation and use behaviors) measured at 3-month follow-up. These outcomes will also be measured at 1-month follow-up time point.",[259],"Cigarillo Smoking","2025-06-27",{"date":262,"type":38},"2025-07-02",{"date":264,"type":38},"2025-04-17",{"date":266,"type":22},"2026-08-31",{"name":44,"class":45},2,{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":17,"minAge":275,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":287,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":46},"100536402","developing-a-nonpharmacological-pain-intervention-for-community-dwelling-older-adults-with-dementia-100536402","NCT06264362","Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia","Inclusion Criteria for people living with dementia:\n\n* Age 60 or older\n* Speaks English\n* Mild\u002FVery Mild dementia\n* Knee pain lasting ≥ 3 months, potentially related to arthritis\n* Knee pain is at least 2 out of 10 on average.\n\nExclusion Criteria for people living with dementia:\n\n* Reside in long term care facility\n* Unable or unwilling to consent\n* Has a condition with a life expectancy of less than 1-year\n* No care partner who is also willing to participate\n* Recent changes to pain or psychotropic medications in the last 60 days\n* Recent knee surgery in the last 1-year\n* Has a condition that contraindicates exercise (Phase 2 only)\n* Currently receiving rehab services (Phase 2 only)\n\nFor care partners:\n\n* No sex, gender, or age criteria\n* Has known person living with dementia ≥ 1 year\n* Speaks English\n* Able and willing to consent, including being recorded\n\nFor clinicians:\n\n* No sex, gender, or age criteria\n* Speaks English\n* Has ≥ 2 years of experience working with community-dwelling people with dementia and pain\n* Able and willing to consent, including being recorded","60 Years",{"count":277,"type":22},40,[25],"The purpose of this study is to develop an exercise treatment program for knee osteoarthritis that works well for people with memory problems. This study will include two parts. Participants can choose to participate in either or both parts.\n\nIn Part 1 (not a clinical trial) - The investigators are inviting the following people to participate in an interview:\n\n1. Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain.\n2. Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly.\n3. Clinicians (exercise physiologists or rehabilitation therapists like physical and occupational therapists) who have worked with older adults with memory issues and knee pain.\n\nThe goal of these interviews is to learn from the experiences of people with memory issues and knee pain and those who care for them. From these interviews, the investigators hope to design a non-drug, tailored physical activity program that will be interesting and helpful in managing knee pain for older adults with memory problems.\n\nFor people with memory problems and knee pain and their care partners: The investigators will ask some questions to determine eligibility to participate in the study.\n\nThose who qualify for the study will be invited to participate in an interview that could be completed online or in person (Philadelphia, PA). The interview could last up to 90 minutes (1 and a half hours) and can be completed as one or multiple sessions.\n\nFor clinicians: Participants will engage in a 90-minute focus group with other clinicians where lunch will be served if in person. Those participating in an online focus group will receive a gift card equal to the value of lunch.\n\nIn Part 2 (a clinical trial) - The program developed in Part 1 will be tested. The program will be physical activity-based. Specific program details for part 2 will be provided as they emerge. Participants can choose to sign up for either or both parts. Signing up for Part 1 does not mean participants have to sign up for Part 2.\n\nPlease contact us for any questions.",[281,282,283,284,285,286],"Pain, Chronic","Dementia, Mild","Mobility Limitation","Physical Disability","Osteo Arthritis Knee","Mild Cognitive Impairment",[288,289,290,291,292,293],"pain","dementia","cognitive impairment","osteoarthritis","knee pain","memory","2025-03-10",{"date":296,"type":38},"2025-03-11",{"date":298,"type":22},"2025-06-02",{"date":300,"type":22},"2027-05-01",{"name":44,"class":45},{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":308,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":314,"conditions":315,"keywords":318,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":46},"100578943","phase-1-a-self-guided-mobile-intervention-for-adults-with-binge-eating-and-obesity-100578943","NCT06817863","A Self-Guided Mobile Intervention for Adults With Binge Eating and Obesity","Inclusion Criteria:\n\n1. Are English speaking male or female\n2. Are aged 18-70 years\n3. Have recurrent objective or subjective binge eating episodes (≥12 episodes in 3 months)\n4. Have BMI ≥30\n5. Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher\n6. Are willing and able to complete enrollment procedures\n7. Are able to understand the nature of the study and provide written informed consent\n\nExclusion Criteria:\n\n1. Are unable to fluently speak, write and read English.\n2. Are already receiving treatment for an eating disorder (e.g., research participants cannot be receiving concurrent eating disorder treatment from another provider)\n3. Are receiving weight loss treatment (behavioral or pharmacological)\n4. Have a mental handicap or are currently experiencing severe psychopathology that would limit their ability to engage in study (e.g., imminent or high risk for suicide, substance use disorder, active psychotic disorder,)\n5. Are purging and\u002For using laxatives 3 or more times per week and are not deemed safe for remote treatment by a primary care provider.\n6. Are exercising 2 or more hours a day on average, or engaging in significantly harmful compensatory behaviors (i.e., \\> 3x\u002Fweek of self-induced vomiting or laxative use), and are not deemed safe for remote treatment by a primary care provider.\n7. Are fasting for 24 hours or more, \\> 3x times a week, and are not deemed safe for remote treatment by a primary care provider.\n8. Are unwilling to receive medical clearance and\u002For medical monitoring as requested by the study to ensure they are medically safe to participate.\n9. Are pregnant or planning to become pregnant within the next year.\n10. Are individuals who are not yet adults (infants, children, teenagers) Are currently taking any of these medications: Haldol, Loxitane, Mellaril, Moban, Navane, Prolixin, Serentil, Stelaxine, Trilafon, Thoraxine, Abilify, Clozaril, Geodon, Risperdal, Seroquel, Zyprexa\n11. Are adults unable to consent\n12. Are prisoners","70 Years",{"count":310,"type":22},30,[312,313],"PHASE1","PHASE2","The proposed study is an open label, non randomized, waitlist controlled single group feasibility study of the feasibility and usability of a digital intervention (called ChangeBite) to be used by individuals with obesity and comorbid binge eating behavior. The proposed research will include approximately 30 participants. Participants will be recruited for this single group pilot trial using online advertising to attend a virtual screening session. Screened participants willing and eligible to participate, will receive informed consent and formally start ChangeBite. Participants will be instructed to engage with ChangeBite and attend follow up assessments on scheduled video calls. Feasibility and acceptability of implementation will be assessed by collecting data on recruitment, retention, usability and satisfaction. The research team will also collect assessment data from participants on feasibility, and usability. In addition to self report scales, semi-structured interviews will be completed with a trained research team member via video call and will be partially recorded. Assessments will be done at baseline, 12 weeks, and 24 weeks. Participants' app use frequency and duration will be tracked using software analytics. Participants' body weight will be captured weekly using a timestamped picture of their weight as it appears on their scale and Body Mass Index will be calculated with these data points.",[316,317],"Binge Eating Disorder Associated With Obesity","Binge Eating Disorder",[319,320,321],"digital treatment","self-help intervention","binge eating","2025-02-13",{"date":324,"type":38},"2025-02-17",{"date":326,"type":22},"2025-02",{"date":328,"type":22},"2025-12",{"name":44,"class":45},{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":17,"minAge":338,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":23,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":46},"100559743","environmental-and-sensory-intervention-for-nursing-home-residents-with-dementia-who-exhibit-persistent-vocalizations-100559743","NCT06568107","Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations","A Person-Centered Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations","EASE","Inclusion Criteria:\n\n* The participants must: 1) have a medical diagnosis of dementia; 2) have severe dementia as determined by a MMSE score of ≤9 (or another cognitive test indicating severe dementia); 3) have a history of PVs per staff report; 4) be 50 years older or greater; 5) require extensive assistance by staff to ambulate or is non-ambulatory (to allow for consistent video recording). In addition, consent will be obtained from the resident's Legally Authorized Representative (LAR) and assent from the participant.\n\nExclusion Criteria:\n\n* Persons living with dementia will be excluded if they: 1) are blind; 2) are deaf; 3) give indications of dissent. Variations will be sought for gender, race and ethnicity.","50 Years",{"count":340,"type":22},32,[25],"The purpose of this study is to test a person-centered, nature-based non-pharmacological intervention for nursing home residents living with dementia who exhibit persistent vocalizations. The Environmental And Sensory Experience (EASE) involves the projection of a still nature image and the playing of nature sounds. Family members of the person living with dementia provide consent for the resident to participate in the study and complete a brief survey on nature preferences on the resident's behalf. The survey informs the research team on what nature scene to show. Participants will wear a watch that measures stress levels and research staff will monitor vocalization patterns. We will also recruit persons living with dementia from other settings such as assisted living, personal care units, and adult day care settings.",[344],"Dementia","2025-02-05",{"date":347,"type":38},"2025-02-06",{"date":349,"type":38},"2024-10-31",{"date":351,"type":22},"2025-07",{"name":44,"class":45},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":75,"sex":17,"minAge":18,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":46},"100537173","the-effects-of-an-acute-dose-of-a-betalain-rich-concentrate-on-repeated-sprint-cycling-performance-and-recovery-100537173","NCT06274385","The Effects of an Acute Dose of a Betalain-rich Concentrate on Repeated-sprint Cycling Performance and Recovery.","The Effects of an Acute Dose of a Betalain-rich Concentrate on Repeated-sprint Cycling Performance and Recovery: A Randomized, Double-blind, Crossover, Placebo-control Study.","BET_RSE","Inclusion Criteria:\n\n* Healthy, recreationally active males and females\n* Aged 18-40\n* Free of disease or injury\n\nExclusion Criteria:\n\n* Have any musculoskeletal injuries that could be made worse by participating in this study (e.g., sprain or strain of lower limb)\n* Have documented medical conditions (i.e., hypertension, asthma, heart disease, diabetes) or exhibit signs and symptoms of medical conditions\n* Taking any medication that would interfere with the interpretation of our results. These include, but are not limited to, anti-inflammatory drugs, antibiotics, anti-hypertensives, and any medicine controlling the digestive system.","40 Years",{"count":363,"type":22},10,[25],"Betalains have well-known antioxidant and anti-inflammatory properties. Recent investigations examining the effects of a betalain-rich concentrate (BRC) on exercise and recovery performance show promise of BRC as an ergogenic aid. To date, no study has examined the effects of a single dose of a BRC on supramaximal performance and recovery. Therefore, the purpose of this study is to examine the effects of an acute dose of BRC on repeated-sprint cycling performance and recovery.",[367],"Nutraceuticals",[369,370,371,372],"betalains","beetroot","repeated sprint performance","supplement","2024-11-20",{"date":375,"type":38},"2024-11-22",{"date":377,"type":38},"2024-03-06",{"date":379,"type":22},"2025-08",{"name":44,"class":45},{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":75,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":23,"phases":390,"briefSummary":391,"conditions":392,"keywords":395,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":403,"leadSponsor":405,"locationsCount":4},"100556301","culinary-medicine-for-cancer-caregivers-100556301","NCT06523322","Culinary Medicine for Cancer Caregivers","Culinary Medicine for Caregivers: Improving Pediatric Cancer Patient and Caregiver Outcomes Through Nutrition and Culinary Support","\\*Please note the above age limit and 'accepts health volunteers' specifications are related to the caregiver as the participant. Additional age limit criteria for patient is listed below. All caregivers will be providing care for a child undergoing current cancer treatment.\n\nInclusion Criteria, Patient:\n\n* Receiving active cancer treatment for a liquid or solid cancer diagnosis\n* At least 4-17 years of age\n* English-speaking\n* Taking \\>50% intake orally\n* Approved to participate by both their oncologist and registered dietitian nutritionist\n\nExclusion Criteria, Patient:\n\n* Undergoing bone marrow transplantation\n* Receiving active cancer treatment for a brain tumor\n\nInclusion Criteria, Caregiver:\n\n* Caregiver (parent or legal guardian) of a child who meets the inclusion and exclusion criteria for patients, above\n* Can read and speak English\n* Has access to a computer (i.e., tablet, laptop, desktop computer) and internet\n* Is at least 18 years of age\n* Has the ability to provide informed consent",{"count":389,"type":22},20,[25],"Pediatric cancer and the therapies used in treatment can affect nutritional status, which can impact treatment tolerance, survival, and overall well-being. Poorly managed side effects can lead to long-term poor dietary habits. Caregivers who endure the psychosocial toll of these effects, also face risks to their own well-being. Prioritizing interventions that enhance caregivers' ability to provide quality care and improve long-term health is crucial. The primary aim of this study is to determine the feasibility and acceptability of an 8-week culinary medicine intervention with caregiver coaching for caregivers of children undergoing cancer treatment. The secondary aim is to estimate the effect of the intervention on caregiving preparedness, caregiver self-confidence for managing patient treatment side effects, eating-related distress, and dietary intake. In-depth interviews will explore participant experiences and perspectives on the feasibility and acceptability of the culinary nutrition program, and to inform interpretation of findings and future program refinement.",[130,132,393,394],"Cancer, Treatment-Related","Nutrition Aspect of Cancer",[396,397,398],"Culinary medicine","Nutrition","Cancer caregiver","2024-07-25",{"date":401,"type":38},"2024-07-26",{"date":399,"type":22},{"date":404,"type":22},"2025-01-30",{"name":44,"class":45},{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":75,"sex":413,"minAge":414,"maxAge":415,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":46},"100527454","an-acceptance-based-healthy-lifestyle-intervention-for-diverse-adolescents-100527454","NCT06147973","An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents","Wellness Achieved Through Changing Habits (WATCH): An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents","Inclusion Criteria:\n\n* Ages 14-19\n* Gender identification as girl\n* BMI percentile ≥ 85th percentile for sex-and-age\n\nExclusion Criteria:\n\n* Experience of weight loss of ≥5% of body weight in the past 6 months for any reason except post-partum weight loss\n* Having recently begun or changed the dosage of any medication known to affect appetite or body composition within the last 3 months\n* Plans to move out of the area within the next year\n* Active cancer or cancer requiring treatment in the past 2 years (except non-melanoma skin cancer)\n* Active or chronic infections (e.g., HIV or TB)\n* Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease in the past 6 months\n* Active kidney disease\n* History of bariatric surgery\n* Lung disease: chronic obstructive airway disease requiring use of oxygen (e.g., emphysema or chronic bronchitis)\n* Diagnosed diabetes (type 1 or 2)\n* Any condition prohibiting physical activity\n* Diagnosis of an eating disorder\n* Have a mental handicap or are currently experiencing other severe psychopathology that would limit their ability to engage in the treatment program (e.g., severe depression, active psychotic disorder)\n* Recent or ongoing problem with drug abuse, alcohol abuse, or addiction\n* Currently pregnant or less than 3 months post-partum\n* Anticipation of a possible pregnancy in the next year\n* Unwillingness to report possible or confirmed pregnancies promptly during the course of the trial","FEMALE","14 Years","19 Years",{"count":417,"type":22},148,[25],"The goal of this clinical trial is to learn about cardiovascular disease risk among adolescent girls with overweight\u002Fobesity. The main questions this trial aims to answer are:\n\n1. Does an acceptance-based healthy lifestyle intervention demonstrate more weight loss than a health education intervention?\n2. Does an acceptance-based healthy lifestyle intervention show more improvements in participants' physiological, health-related, and psychological factors compared to a health education intervention?\n\nParticipants in this trial will:\n\n1. Engage in treatment for 6-months, comprising of a mixture of in-person and remote group sessions, occurring at Drexel University or over a video-conferencing platform.\n2. Complete various assessments. These include self-reported questionnaires, measures of weight, height, body composition, blood pressure, and blood lipids, and wearing of smart watches to measure sleep and physical activity.\n\nResearchers will compare the acceptance-based and health education intervention groups to see if the acceptance-based treatment will indeed be effective in improving participants' health outcomes.",[421],"Overweight and Obesity",[423,424,425,426],"adolescent obesity","cardiovascular disease risk","healthy lifestyle intervention","acceptance-based","2024-04-09",{"date":429,"type":38},"2024-04-10",{"date":431,"type":38},"2024-02-14",{"date":433,"type":22},"2028-01-01",{"name":44,"class":45},""]