[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Center for Clinical Research and Prevention\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":196},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,82,109,142,165],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100624765","the-stime-project-intersectoral-prevention-of-severe-youth-mental-health-difficulties-100624765",false,"NCT07413887","The STIME Project: Intersectoral Prevention of Severe Youth Mental Health Difficulties","STIME","Each of the interventions has elaborate and narrowly defined inclusion and exclusion criteria. These are listed below for each intervention.\n\n'Signs of Internalizing'\n\nInclusion criteria\n\n* Adolescents aged 12-17 years\n* Mild to moderate impairment in daily functioning (e.g., reduced engagement in school, social life, or leisure activities compared to before symptoms)\n* Adolescents with well-managed ADHD or autism may be included if they demonstrate sufficient mentalizing abilities and can benefit from the intervention with parental support\n* Presence of both anxiety and depressive symptoms, neither of which dominates or meets full diagnostic criteria\n* The family is motivated to participate\n\nExclusion criteria\n\n* Symptoms of moderate to severe depression\n* Presence of OCD, PTSD, agoraphobia, panic disorder, or other psychiatric conditions\n* Low cognitive functioning\n* Moderate to severe functional impairment (e.g., school dropout, extreme social withdrawal, daily reliance on adult support, lack of motivation for treatment)\n* Recent unsuccessful psychological treatment\n* Primary problems related to family dynamics or a highly burdened family situation\n* Increased or acute suicide risk\n* Presence of self-harm or symptoms of disordered eating\n\n'Signs of Disordered Eating'\n\nInclusion criteria\n\n* Children and adolescents aged 10-17 years\n* High body dissatisfaction, preoccupation with food and\u002For body image, and\u002For early behavioral signs of an eating disorder\n* Stable physical condition, manageable in consultation with the adolescent's general practitioner\n* Able to consume food with guidance and support\n* The family is motivated to participate\n\nExclusion criteria\n\n* Previous treatment for an eating disorder\n* Symptoms meeting criteria for specialized psychiatric treatment\n* Low cognitive functioning\n* Significant weight loss\n* Solely restrictive or selective eating without other eating disorder symptoms\n* Severe comorbidity\n* Increased or acute suicide risk\n* Eating difficulties solely related to lifestyle factors\n\n'Signs of Self-Harm'\n\nInclusion criteria\n\n* Adolescents aged 12-17 years\n* Current thoughts of self-harm\n* At least one episode of direct (non-suicidal) self-harm within the past three months\n* The family is motivated to participate\n\nExclusion criteria\n\n* Increased suicide risk\n* Psychiatric disorder requiring further assessment or not adequately treated\n* Low cognitive functioning\n* Self-harm only in socially accepted contexts (e.g., piercings or tattoos)\n* Only indirect self-harm (e.g., excessive substance use)\n* Only self-harm by proxy (involving another person)\n\n'Take the Control Back'\n\nInclusion criteria\n\n* Children and adolescents aged 5-17 years\n* Experiencing obsessive thoughts and\u002For compulsive behaviors of mild to moderate severity\n* Experiencing self-perceived distress related to obsessive thoughts and\u002For compulsive behaviors\n* Experiencing obsessive thoughts as egodystonic, and thus aware that they are excessive (for the youngest participants, this criterion may be waived in cases of limited insight)\n* Functioning is impaired by obsessive thoughts and\u002For behaviors, e.g., reduced school functioning, social difficulties, or impaired functioning at home\n* The family is motivated to participate\n\nExclusion criteria\n\n* Symptoms meeting criteria for specialized psychiatric treatment\n* Has another psychiatric disorder that requires assessment or is not adequately managed\n* Has difficulties other than obsessive thoughts and behaviors that currently constitute the primary burden, and which must be addressed first\n* Has previously received OCD treatment within psychiatric care (may be offered STIME if assessed but not treated due to mild severity)\n* Has an increased or acute risk of suicide\n* Has low functioning for other reasons, e.g., significantly reduced cognitive functioning\n\n'the Parent Pilots'\n\nInclusion criteria\n\n* Parents of children aged 3-10 years who experience developmentally inappropriate difficulties with restlessness, hyperactivity, attention, and\u002For impulsivity\n* The symptoms must be present at home as a minimum, but may also occur across settings such as home, daycare, and school\n* The child's difficulties must be significant enough to affect overall daily functioning\n* The parents are motivated to participate\n\nExclusion Criteria:\n\n* Symptoms of attention difficulties that require psychiatric treatment\n* Presence of another psychiatric disorder that requires treatment\n* Previous treatment for ADHD within the psychiatric system\n* Low level of functioning due to other causes, such as significantly reduced cognitive functioning","ALL","3 Years","17 Years",{"count":20,"type":21},1200,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized controlled trial aims to evaluate the effectiveness of participation in five different STIME (Strengthened Cross-Sectoral Initiative for Children and Young People's Mental Health) interventions: 'Signs of Disordered Eating', 'Signs of Internalizing', 'Signs of Self-Harm', 'Take the Control Back', and 'The Parent Pilots'. The hypothesis is that participation in one of these interventions will be more effective than Management As Usual (MAU). Each intervention consists of three core components: early identification and screening, therapy based on evidence-informed manuals, and support within the child's learning environment.",[27,28],"Preventive Intervention","Mental Health Difficulties",[30,31,32,33,34,35],"Mental Health","Adolescents","Children","Preventive intervention","Sub-clinical symptoms","Randomized controlled trial","RECRUITING","2026-05-29",{"date":39,"type":40},"2026-06-01","ACTUAL",{"date":42,"type":40},"2025-11-20",{"date":44,"type":21},"2028-02-01",{"name":46,"class":47},"Center for Clinical Research and Prevention","NETWORK",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100502420","promoting-pupils-physical-literacy-100502420","NCT05822024","Promoting Pupils' Physical Literacy","3PL","Inclusion Criteria:\n\nSchool\u002Fclass-level\n\n* Non-special needs municipal school classes\n* Classes that are not in other school development or research projects which would most likely influence and bias the results\n\nPupil-level\n\n* Pupils with parents\u002Fguardians who have provided written informed consent, allowing their child to participate\n* Pupils who have provide an oral assessment\n\nExclusion Criteria:\n\n* Pupils who do not live up to the inclusion criteria",true,"8 Years","13 Years",{"count":60,"type":21},336,[24],"This pilot study aims to test the feasibility and acceptability of a previously developed and tested physical literacy (PL) intervention. A promising and internationally tested intervention, the Youth Physical Activity Towards Health (Y PATH), is based on the theory of PL and has proven to be effectful on children's PA levels and motor skills The Promoting Pupils' Physical Literacy (3 PL) project aims to test the feasibility and acceptability of the previously developed and tested Y-PATH intervention in a Danish context among a pupils (9 11 years of age). The hypothesis is that a revised 3 PL intervention protocol, aiming to increase pupils' PL, is ready for effectiveness testing by the end of this project.",[64],"Literacy",[66,67,68,69,70,71,72],"Physical literacy","Physical education","School children","School based intervention","Education","Health promotion","Prevention","2026-03-18",{"date":75,"type":40},"2026-03-20",{"date":77,"type":40},"2023-02-01",{"date":79,"type":21},"2026-09-30",{"name":46,"class":47},3,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100613571","plant-based-diet-for-patients-with-rheumatoid-arthritis-100613571","NCT07268326","Plant-Based Diet for Patients With Rheumatoid Arthritis","PLATE: Health Effects of Plant-Based Diet in Patients With Rheumatoid Arthritis","Inclusion Criteria:\n\n* Age ≥18 years\n* DAS28 score ≤3.2, and without swollen joints\n* RA diagnosis of minimum one year\n* Stable pharmacological treatment for at least four months and with no planned change in treatment within eight weeks\n\nExclusion Criteria:\n\n* Smokers\n* Diabetes mellitus\n* Pregnancy \u002F planned pregnancy\n* Prednisolone treatment\n* DAS28 above 3.2\n* Current dietary habits resembling intervention diet (e.g., PBD lifestyle)\n* Food allergies and intolerances\n* Unable to understand the informed consent and study procedures","18 Years",{"count":91,"type":21},180,[24],"The goal of this clinical trial is to evaluate the effect of a plant-based diet (PBD) intervention in adults with Rheumatoid Arthritis (RA) on disease activity.\n\nThe investigators hypothesize that if patients with RA follow a 100% PBD over a 16-week period it will lead to improvements in:\n\n\\- Disease activity (measured by DAS28), including reduction in symptoms and overall improvements in health-related quality of life.\n\nThe effects of the PBD will be compared to a habitual diet, that includes no dietary changes.\n\nParticipants in the intervention group will:\n\n* Receive weekly delivery of food boxes which include plant-based food items\n* Receive a daily multivitamin supplement\n* Receive continuous dietetic guidance\n* Participate in a practical cooking class to get an introduction to a PBD\n* Participate in three online supervisions throughout the intervention period\n\nParticipants in the control group will follow the same plan for the project visits at the hospital but will be restricted to continue their habitual diet. Thus, not performing any dietary changes.",[95],"Rheumatoid Arthritis (RA)",[97,98,99,100],"Rheumatoid Arthritis","Plant-based","Dietary intervention","Clinical nutrition","2026-03-17",{"date":73,"type":40},{"date":104,"type":40},"2025-12-15",{"date":106,"type":21},"2028-12",{"name":46,"class":47},2,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":56,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":48},"100612027","developing-and-evaluating-a-digital-intervention-aiming-to-support-informal-caregivers-of-people-with-dementia-100612027","NCT07248241","Developing and Evaluating a Digital Intervention Aiming to Support Informal Caregivers of People With Dementia","The Caregiver Education Resource for Dementia (CARE-Dem) Study: Developing and Evaluating a Digital Intervention to Support Informal Caregivers of People With Dementia","Inclusion Criteria:\n\n\\- Adult family members\u002Frelatives\u002Fother adult informal caregivers of a newly diagnosed person with dementia\u002Fa person with mild dementia\n\nExclusion Criteria:\n\n* Unable to speak\u002Funderstand Danish\n* Incapable of collaborating about signing the informed consent",{"count":117,"type":21},40,[24],"The goal of this feasibility trial is to test the acceptability and feasibility of a new digital education pro-gram, the Caregiver Education Resource for Dementia (CARE-Dem). This is a behavioral (non-medical) intervention, designed to support informal caregivers of people with dementia. The primary purpose is to explore whether this program can help improve wellbeing and reduce burden among informal caregivers. The study focuses on adult caregivers, such as spouses, partners, relatives, or close friends of people recently diagnosed with dementia or living with mild dementia.\n\nThe main questions it aims to answer are:\n\n* Is it possible to recruit and retain caregivers to participate in this type of digital intervention?\n* Do participants find the program relevant, useful, and acceptable? Are the study procedures and outcome measures (such as questionnaires) suitable and manage-able for the participants?\n* Does the intervention show preliminary signs of reducing caregiver burden and improving care-givers' wellbeing, knowledge, quality of relationship with the person with dementia, ability to ac-cept the situation, and feelings of being capable of managing their caregiving role? Researchers will compare caregivers who receive the CARE-Dem program with a control group who are offered the usual municipal information sessions. This allows us to see whether the digital pro-gram is feasible and whether it shows signs of effect compared with standard practice.\n\nParticipants in the intervention group will be asked to:\n\n• Use the CARE-Dem digital platform over a three-month period.\n\nThe platform includes three modules:\n\nModule 1: Understanding dementia and medical treatment options Module 2: Everyday life and communication with a person with dementia Module 3: Legal and practical matters, and information on support available in the community\n\n* Engage with a mix of learning materials such as short videos, fact sheets, interactive activities, guides, and links to further resources\n* Complete questionnaires at baseline and after 3 months to measure caregiver burden, wellbeing, and self-efficacy\n* Take part in qualitative interviews about their experiences with the program, including usability, satisfaction, acquired knowledge, benefits, and suggestions for improvement.\n\nParticipants in the control group will receive treatment as usual. They will be offered to take part in existing information sessions provided by the municipalities, but attendance is optional. Researchers will record whether or not they attend, in order to compare results across subgroups.\n\nThis feasibility trial will help determine whether it is possible to run a larger evaluation of the CARE-Dem program in the future. If successful, the program could provide flexible and accessible support to the many caregivers of people with dementia, reaching those who cannot attend traditional in-person sessions.",[121,122],"Dementia Caregiver","Digital Education Interventions",[124,125,126,127,128,129,130,131,132],"Complex Intervention","Intervention Development","Intervention Adaptation","Feasibility","Co-Creation","Informal Caregivers","Support Tool","Digital Intervention","Dementia Caregiving","NOT_YET_RECRUITING","2025-12-05",{"date":136,"type":40},"2025-12-12",{"date":138,"type":21},"2025-12",{"date":140,"type":21},"2026-11",{"name":46,"class":47},{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":4},"100576944","nurture-and-play---a-pilot-study-100576944","NCT06791876","'Nurture and Play' - a Pilot Study","'Nurture and Play' - a Randomized Controlled Pilot Study of a Perinatal Intervention to Strengthen Parenting Among Women with Psychosocial Vulnerabilities and Their Partners.","Inclusion Criteria:\n\n* Known with a current or previous history of anxiety and\u002For depression\n* Referred for labour at Slagelse Hospital\n\nExclusion Criteria:\n\n* Age under 18 years old\n* A need for an interpreter\n* Expecting more than one child\n* Known with schizophrenia or other serious mental illness\n* Expecting a child with a known illness\n* A history of alcohol or drug abuse",{"count":150,"type":21},20,[24],"The aim of this randomised controlled pilot study is to evaluate the feasibility of the Nurture and Play (NnP) offered to a Danish population of psychosocial vulnerable pregnant women and their partners.\n\nMore specifically the objectives of the study are to:\n\n* Test the feasibility of the NnP including both parents\n* Evaluate the recruitment procedure, the adherence as well as the participant's and professional´s experience of the intervention\n* Evaluate the collaboration between the hospitals and the municipalities.\n\nThe study consists of:\n\n1. A randomized controlled pilot study (n=20 women\u002Fcouples) carried out according to the Standard Protocol Items: Recommendations for Interventional Trials SPIRIT statement for clinical trials. The parents who agree to participate in the study will be randomly assigned in a 1:1 ratio to either the intervention or the control group. In addition to care-as-usual, the intervention group will be offered to participate in the NnP adapted to include partners. The intervention consists of 11 group sessions (4 perinatal and 7 postnatal sessions) and will be provided to the parents in the intervention group from around 26 weeks gestation until the baby is around seven months old. Each group session will be led by a midwife and a health nurse and will consist of four to five mothers\u002Fcouples.\n2. A qualitative descriptive interview study aiming to evaluate the participants' and professionals´ experience of the intervention.\n\nData will be collected through:\n\n* Online Questionnaires.\n* Interviews.\n* Videotaped settings.",[154,155,156],"Depression, Anxiety","Intervention","Randomized Controlled Study","2025-01-24",{"date":159,"type":40},"2025-01-28",{"date":161,"type":21},"2025-02-15",{"date":163,"type":21},"2026-10-15",{"name":46,"class":47},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":172,"minAge":89,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":108},"100572564","healthypregnancy---digital-support-for-pregnant-women-with-a-bmi-at-25-or-above-bmi25-100572564","NCT06734910","HealthyPregnancy - Digital Support for Pregnant Women with a BMI At 25 or Above (BMI≥25)","Effectiveness of a Digital Support Intervention (HealthyPregnancy) for Pregnant Women with a BMI At 25 or Above (BMI≥25) in Addition to Standard Care: a Stepped-wedge Cluster Randomized Controlled Trial","Inclusion Criteria:\n\n* BMI 25 or above at first prenatal visit\n* Age 18 years or older\n* Singleton pregnancy\n* Appropriate Danish or English language skills\n* Written informed consent\n\nExclusion Criteria:\n\n* Age under 18 years\n* Multiple pregnancy\n* Gestational age above 16+0 at inclusion\n* Alcohol or drug abuse\n* Being diagnosed with eating disorder, schizophrenia, psychosis, or similar\n* Diagnosis of malformations or chromosomal disorder in the fetus\n* Conditions that lead to recommendations against physical activity during pregnancy e.g., cerclage.","FEMALE","60 Years",{"count":175,"type":21},450,[24],"The study aims to examine the effectiveness of a digital care guide offering support and information on diet, physical exercise and mental well-being on pregnancy weight gain among pregnant women with a BMI at 25 or above in a stepped-wedge cluster randomised study.\n\nThe investigators hypothesise that access to a digital care guide focusing on diet, exercise and mental support, will support a reduced weight gain in pregnancy and improve the mental wellbeing of the participants.",[179,180],"Pregnancy Related","Weight Gain",[182,183,184,185,186,187],"Pregnancy","Gestational weight gain","Mental well-being","Digital interventions","Physical activity","Diet","2024-12-10",{"date":190,"type":40},"2024-12-16",{"date":192,"type":40},"2024-09-09",{"date":194,"type":21},"2027-06",{"name":46,"class":47},""]