[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658833":3},{"organization":4,"outcomesModule":7,"designInfo":117,"detailedDescription":120,"studyPopulation":121,"armGroups":122,"interventions":132,"overallOfficials":139,"centralContacts":143,"locations":118,"responsibleParty":149,"collaborators":153,"id":159,"slug":160,"hasResults":161,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":167,"sex":168,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":118,"studyType":174,"phases":118,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":185,"whyStopped":118,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":118},{"fullName":5,"class":6},"Steno Diabetes Center Copenhagen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":84},[9],{"measure":10,"description":11,"timeFrame":12},"Body Mass Index z-scores","Body Mass Index (BMI) z-scores will be calculated from height and weight measurements for all participants using the LMS method with national reference data.","From enrollment in \"The Holbaek Study\" to the individual follow-up visit (follow-up visit: approximately 40 minutes in total)",[14,18,21,24,27,30,33,37,40,43,47,50,53,57,60,63,66,69,72,75,77,79,81],{"measure":15,"description":16,"timeFrame":17},"Strengths and Difficulties Questionnaire, total score","A total difficulty score for overall difficulties based on four domains (the sum of the Emotional symptoms scale + Conduct problems scale + Hyperactivity scale + Peer problems scale), scaled from 0-40 points. Higher values indicating a higher level of difficulties (0-13 points: Normal, 14-16 points: Borderline, 17-40 points: Abnormal).","During the individual follow-up visit (lasting approximately 40 minutes in total)",{"measure":19,"description":20,"timeFrame":17},"The Strengths and Difficulties Questionnaire (SDQ) impact score","An overall distress and impairment score from four domains (ranges from 0 to 10 for parent- and self-report)",{"measure":22,"description":23,"timeFrame":12},"The Pediatric Quality of Life Inventory, total scale score","Total scale score for The Pediatric Quality of Life Inventory. Four subscales, each answered on a 5-point Likert scale from 0 (Never) to 4 (Almost always) or a 3-point Likert scale from 0 (Not at all), 2 (Sometimes) and 4 (A lot). Items are reverse scored and linearly transformed to a 0-100 scale as follows:\n\n0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicating better health related quality of life.",{"measure":25,"description":26,"timeFrame":12},"Body mass index","Body Mass Index (BMI). Calculated for participants \\> 18 years by the equation: BMI = weight (kg) \u002F (height (m) \\* height (m)).\n\nFollowing categories applies:\n\nBelow 18,5: Under weight 18,5 - 24,9: Normal weight 25,0 - 29,9: Overweight Over 30,0: Severe overweight",{"measure":28,"description":29,"timeFrame":12},"Fat mass index (FMI)","FMI serves as a sex- and age-stratified endpoint for adiposity, quantifying total fat mass relative to height squared (kg\u002Fm²). Higher values indicate increased metabolic and cardiovascular risk, while lower values within the normative strata represent favorable outcomes.\n\nClassification Men (All Ages) Women (All Ages) Normal Weight 3.0 - 6.0 5.0 - 9.0 Overfat (Overweight) \\> 6.0 - 9.0 \\> 9.0 - 13.0 Obese (Obesity) \\> 9.0 \\> 13.0",{"measure":31,"description":32,"timeFrame":12},"Fat-free mass index (FFMI)","FFMI serves as a sex- and age-stratified endpoint for lean body mass, quantifying fat-free tissue relative to height squared (kg\u002Fm²). Higher values within the normative strata represent favorable muscular and metabolic reserve.\n\nNormative age-matched lean mass: 16.5 - 19.5 (men), 13.5 - 16.5 (women)",{"measure":34,"description":35,"timeFrame":36},"Waist-to-hip ratio (WHR)","Waist-to-hip ratio is measured in adults. WHR serves as a outcome for abdominal adiposity and visceral fat distribution, quantified as waist circumference divided by hip circumference. Higher values indicate increased central adiposity and an elevated health risk of cardiovascular disease, type 2 diabetes, and metabolic syndrome.\n\nSubstantially Increased Risk: \\> 0.90 (men), \\> 0.85 (women)","During the individual follow-up visit (approximately 40 minutes in total)",{"measure":38,"description":39,"timeFrame":36},"Waist circumference (WC)","Measurement of waist circumference for all participants, results in centimeters with no decimal. WC serves as an outcome for visceral adiposity and intra-abdominal fat accumulation. Higher values indicate an elevated health risk of insulin resistance, cardiometabolic disease, and systemic inflammation.\n\n≥ 94 cm (men), ≥ 80 cm (women): Substantially increased metabolic risk",{"measure":41,"description":42,"timeFrame":36},"Waist circumference-to-height ratio (WHtR)","Waist circumference-to-height ratio (WHtR) is measured in children. WHtR serves as an outcome for central adiposity and early cardiometabolic risk, quantified as waist circumference divided by height. Higher values indicate elevated accumulation of visceral fat and greater cardiovascular risk.\n\nA WHtR cutoff of 0.5 can be used in different sex and ethnic groups and is generally accepted as a universal cutoff for central obesity in children (aged ≥6 years). The additional use of WHtR with BMI and\u002For waist circumference may be helpful because WHtR considers both height and central obesity.",{"measure":44,"description":45,"timeFrame":46},"Prosocial behaviour sub-score from the Strengths and Difficulty Questionnaire","A five item sub-scale to measure prosocial behaviour measured by the Strengths and Difficulties Questionnaire, scaled from 1-10 points. Higher values indicating higher prosocial behavior (6-10 points: Normal, 5 points: Borderline, 0-4 points: Abnormal).","At follow-up visit (lasting approximately 40 minutes in total)",{"measure":48,"description":49,"timeFrame":46},"Peer relationship sub-score from the Strengths and Difficulty Questionnaire","Five item sub-scale to measure peer relationship problems measured by the Strengths and Difficulties Questionnaire, scaled from 0-10 points. Higher values indicating higher peer relationships difficulties (0-2 points: Normal, 3 points: Borderline, 4-10 points: Abnormal).",{"measure":51,"description":52,"timeFrame":46},"Hyperactivity sub-scale from the Strengths and Difficulty Questionnaire","Five item sub-scale to measure hyperactivity\u002Finattention measured by the Strengths and Difficulties Questionnaire, scaled from 0-10 points. Higher values indicating higher Hyperactivity difficulties (0-5 points: Normal, 6 points: Borderline, 7-10 points: Abnormal).",{"measure":54,"description":55,"timeFrame":56},"Conduct problems sub-scale from the Strengths and Difficulty Questionnaire","A five item sub-scale to measure conduct problems measured by the Strengths and Difficulties Questionnaire, scaled from 0-10 points. Higher values indicating higher conduct difficulties (0-2 points: Normal, 3 points: Borderline, 4-10 points: Abnormal).","During follow-up visit (lasting approximately 40 minutes in total)",{"measure":58,"description":59,"timeFrame":56},"Emotional symptoms sub-score from the Strengths and Difficulty Questionnaire","Five item sub-scale about emotional symptoms measured by the Strengths and Difficulties Questionnaire, scaled 1-10 points. Higher values indicating higher emotional difficulties (0-3 points: Normal, 4 points: Borderline, 5-10 points: Abnormal).",{"measure":61,"description":62,"timeFrame":56},"The Short-Form Health Survey (SF-12), mental component summary","A score for the mental component of the SF-12. Higher scores indicate a better health state. items are answered on a 1-5 point Likert scale. The points from the mental domain scale are transformed to total raw scores (0-100) by calculating: ((actual raw score - lowest possible raw score) \u002F possible raw score range ) \\* 100 =transformed scale score. Transformed scale scores from four sub domains (vitality, social functioning, role-emotional, mental health) corresponds to the mental component summery measure (Norm: T-score profile =50).\n\nall calculation is performed according to the USER'S MANUAL FOR THE SF-12V2 HEALTH SURVEY.",{"measure":64,"description":65,"timeFrame":56},"The Short-Form Health Survey (SF-12) physical component summary (pcs)","A score for the physical component of the SF-12. Higher scores indicate a better health state. items are answered on a 1-5 point Likert scale. The points from the physical domain scale are transformed to total raw scores (0-100) by calculating: ((actual raw score - lowest possible raw score) \u002F possible raw score range ) \\* 100 =transformed scale score. Transformed scale scores from four sub domains (physical functioning, role-physical, bodily pain, general health) corresponds to the mental component summery measure (Norm: T-score profile =50).\n\nall calculation is performed according to the USER'S MANUAL FOR THE SF-12V2 HEALTH SURVEY.",{"measure":67,"description":68,"timeFrame":17},"The WHO-5 Well-Being Index raw score","A total score for WHO-5. The WHO-5 is a 5-item patient-reported outcome (PRO) instrument measuring subjective psychological well-being over a 2-week recall period. Each item is scored from 0 (at no time) to 5 (all of the time), yielding a raw score from 0 to 25. Lower raw scores (\\\u003C13) indicate poor emotional well-being and potential depressive risk.",{"measure":70,"description":71,"timeFrame":36},"Eating Disorder Examination Questionnaire - Short (EDE-QS) total score","Each of the 12 items is rated on a 4-point Likert scale. The aggregate total score ranges from 0 to 36. Higher total scores reflect higher overall symptom severity and more pronounced eating\u002Fbody image concerns.",{"measure":73,"description":74,"timeFrame":12},"Pediatric quality of Life inventory (PedsQL) Physical Functioning score","A subscale on the Pediatric quality of Life inventory, answered on a 5-point Likert scale from 0 (Never) to 4 (Almost always) or a 3-point Likert scale from 0 (Not at all), 2 (Sometimes) and 4 (A lot). Items are reverse scored and linearly transformed to a 0-100 scale as follows:\n\n0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicating better health related quality of life.",{"measure":76,"description":74,"timeFrame":12},"Pediatric quality of Life inventory (PedsQL), Emotional Functioning",{"measure":78,"description":74,"timeFrame":12},"The Pediatric quality of Life inventory (PedsQL), Social Functioning",{"measure":80,"description":74,"timeFrame":12},"Pediatric quality of Life inventory (PedsQL), School Functioning score",{"measure":82,"description":83,"timeFrame":12},"The Pediatric quality of Life inventory (PedsQL), Psychosocial Health Summary Score","Sum of the items over the number of items answered in the Emotional, Social, and School Functioning Scales. Higher scores indicating better health related quality of life.",[85,88,91,95,99,102,105,107,109,111,113,115],{"measure":86,"description":87,"timeFrame":46},"Tanner Stage (self-assesment)","The Tanner scale divides puberty into 5 distinct stages (Stage 1 = pre-puberty, Stage 5 = adult development). The questionnaire include standardized line drawings, allowing the child\u002Fadolescent to select the image that most accurately matches their own body.",{"measure":89,"description":90,"timeFrame":17},"Weight categories","Weight categories will be determined using the extended international (IOTF) BMI cut-offs for children and BMI cut-offs as defined by WHO for adults",{"measure":92,"description":93,"timeFrame":94},"Treatment for overweight (self-reported)","Questions to obtain information about current or past treatment for overweight","At follow-up visit (lasting approximately 40 minutes ti total)",{"measure":96,"description":97,"timeFrame":98},"Perceived overall experience with the treatment with the Children's Obesity Clinic's Treatment protocol","Open-ended question to report perceived experience (positive or negative) with the Children's Obesity Clinic's Treatment protocol","At the follow-up visit (lasting approximately 40 minutes in total)",{"measure":100,"description":101,"timeFrame":46},"Perceived experience of the Children's Obesity Clinic's Treatment protocol (self-efficacy)","Single item on a 7 point Likert scale (from \"not at all\" to \" to a very high degree\" and an option to respond 'not applicable'). Higher value indicating better experience.",{"measure":103,"description":104,"timeFrame":46},"Perceived experience of the Children's Obesity Clinic's Treatment protocol ( caring and reassuring atmosphere )","Single item on a 7-point Likert scale (from \"not at all\" to \" to a very high degree\" and an option to respond 'not applicable'). Higher value indicating better experience.",{"measure":106,"description":104,"timeFrame":46},"Perceived experience of the Children's Obesity Clinic's Treatment protocol (dialogue)",{"measure":108,"description":104,"timeFrame":46},"Perceived experience of the Children's Obesity Clinic's Treatment protocol (holistic approach)",{"measure":110,"description":104,"timeFrame":46},"Perceived experience of the Children's Obesity Clinic's Treatment protocol (consultation time pressure)",{"measure":112,"description":104,"timeFrame":46},"Perceived experience of the Children's Obesity Clinic's Treatment protocol (individual approach)",{"measure":114,"description":104,"timeFrame":46},"Perceived experience of the Children's Obesity Clinic's Treatment protocol (language)",{"measure":116,"description":104,"timeFrame":46},"Perceived experience of the Children's Obesity Clinic's Treatment protocol (tailored approach)",{"allocation":118,"interventionModel":118,"interventionModelDescription":118,"primaryPurpose":118,"observationalModel":119,"timePerspective":6,"maskingInfo":118},null,"COHORT","The active follow-up study is designed as an observational cohort study using two cohorts.\n\nSince the study aims to perform a long-term follow-up of patients treated according to the HM since 2008, a randomized controlled trial is not feasible. Due to the observational design, the study will not conclude on the efficacy of the HM compared with alternative treatment methods or no treatment. Instead, the study will provide a comprehensive description of long-term health and well-being outcomes among individuals treated for pediatric obesity and will investigate the potential influence of factors such as treatment duration and treatment response on these outcomes.\n\nRecruitment procedures:\n\nParticipants will be invited via secure digital mail (E-boks), with a follow-up reminder sent one week later. For participants younger than 15 years, the invitation will be sent to the legal guardians; for participants 15-17 years, the invitation will be sent to the E-boks of the adolescent and the legal guardians; and for participants aged 18 years or above, it will be sent to the E-boks of the young adult only. The invitation letters and reminders will inform potential participants about the study purpose and what participation involves. Contact details will be provided, allowing potential participants to call or email the project team for further information, to schedule an appointment, or to decline participation. The invitation letter and reminder will include a link and QR-code to a webpage describing the project, including a brief video presentation, and a contact formula to request further information. The invitation letter will also include a statement that the investigators will follow up by telephone if the participant\u002Flegal guardian has not responded within 14 days of the first invitation.\n\nIf the investigators have not heard from the participant\u002Flegal guardians within 14 days of the first invitation (seven days from the reminder), the investigators will attempt to reach them by telephone. If there is no answer to the call, a short text message will be sent with information about who called, why, and how to receive more information about the study or decline participation. If the investigators fail to reach participants\u002Flegal guardians after two calls, a physical letter identical to the E-boks reminder will be sent.\n\nParticipants are considered lost to contact if none of the above-mentioned channels are successful.\n\nThe first contact aims to briefly inform potential participants about the project and, if interested, to schedule a time for an oral participant information session at a time and setting that allows for an undisturbed conversation. It will also be possible to book an appointment straight away. If the potential participant does not wish to be contacted, this will be recorded.","Treatment cohort:\n\nHolbæk Hospital has established a research cohort of all individuals who were enrolled in pediatric obesity treatment at the Holbæk Hospital Children's Obesity Clinic from March 2007 and onwards. The present study will include the subset of this cohort who initiated treatment from 1.1.2008-31.12.2025, were aged 5-17 years at treatment start, and are aged 7-30 years at follow-up (expected n=3,400) .\n\nReference cohort:\n\nAs the reference cohort, a subset of a previously established cohort recruited from the general population in the Capital and Zealand Regions during 2010-2016 will be used. In the original cohort, 3,811 children and adolescents aged 2-19 years were recruited from schools and municipal dental clinics in 11 municipalities. For the present study, the investigators will invite the subset of the reference cohort who were aged 5-17 years at enrolment and are aged 18-30 years at follow-up (expected n=2,700).",[123,128],{"label":124,"type":118,"description":125,"interventionNames":126},"Treatment cohort","Holbæk Hospital has established a research cohort of all children, adolescents, and young adults who were enrolled in pediatric obesity treatment at the Holbæk Hospital Children's Obesity Clinic from March 2007 and onwards (The Holbaek Study). As of December 2024, the cohort included a total of 4,115 patients. The present study will include the sub-set of this cohort who initiated treatment from 1.1.2008-31.12.2025, were aged 5-17 years at treatment start and are aged ≤30 years at follow-up (expected n=3,400).",[127],"Other: The AFTER study - Assessing Future Trajectories of hEalth- and well-being among childhood obesity treatment Recipients",{"label":129,"type":118,"description":130,"interventionNames":131},"Population-based reference cohort","As the reference cohort, a subset of a previously established cohort recruited from the general population in the Capital and Zealand Regions during 2010-2016 (The Holbaek Study) will be used. In the original cohort, 3,811 children and adolescents aged 2-19 years were recruited from schools and municipal dental clinics in 11 municipalities. Data collection took place on school property in a mobile laboratory by trained healthcare staff or at scheduled visits to the dental clinic or the school nurse. Since the reference cohort was established 10-15 years ago, due to their age at follow-up, these persons will only contribute as a reference group for the young adults in the treatment cohort (aged 18-29 years at follow-up) to ensure comparability with respect to age. For the present study, the investigators will invite the subset of the reference cohort who were aged 5-17 years at enrolment and are aged 18-30 years at follow-up (expected n=2,700)",[127],[133],{"type":6,"name":134,"description":135,"armGroupLabels":136,"otherNames":137},"The AFTER study - Assessing Future Trajectories of hEalth- and well-being among childhood obesity treatment Recipients","The study design is observational, with a single long-term follow-up measurement and register data.\n\nThe AFTER study includes long-term follow-up for prior patients treated with \"The Holbæk-model\" (The Holbaek Study), which is a treatment approach for pediatric obesity developed and implemented since 2008 at the Department of Pediatrics at Holbæk Hospital in Denmark.\n\nThe Holbæk-model a is family-centered treatment plan to individually balance and mitigate obesity-related risk factors in the child's life by providing individually tailored lifestyle advice in a detailed plan. Patients aged \\\u003C20 years with age- and sex-specific body mass index (BMI) above the 99th percentile are eligible for treatment, and these persons are usually referred by their general practitioner or school nurse. Visit frequency is highly variable, depending on the individual patient's needs. The treatment has no time limit, but patients can remain in treatment only until age 24.",[129,124],[138],"Holbaek-model - long-term follow-up",[140],{"name":141,"affiliation":5,"role":142},"Ulla Toft, Professor","PRINCIPAL_INVESTIGATOR",[144],{"name":145,"role":146,"phone":147,"phoneExt":118,"email":148},"Tine Buch-Andersen, PhD","CONTACT","+4521491874","tine.buch-andersen@regionh.dk",{"type":150,"investigatorFullName":151,"investigatorTitle":152,"investigatorAffiliation":5,"oldNameTitle":118,"oldOrganization":118},"SPONSOR_INVESTIGATOR","Ulla Toft","Professor, Head of Department of Prevention, Health Promotion and Community Care",[154,157],{"name":155,"class":156},"Centre for Childhood Health","UNKNOWN",{"name":158,"class":156},"The Children's Obesity Clinic, Holbaek Hospital","100658833","long-term-follow-up-after-childhood-obesity-100658833",false,"NCT07857018","Long-term Follow-up After Childhood Obesity","Assessing Future Trajectories of Health and Well-being Among Early Childhood Obesity Treatment Recipients","AFTER","Treatment cohort:\n\nInclusion Criteria:\n\n* At least one treatment contact for childhood overweight or obesity at the Children's Obesity Clinic at Holbæk Hospital during 1.1.2008-31.12.2025\n* Age 5 -17 at treatment initiation\n* Age 7 - 30 years at invitation to follow-up\n\nExclusion Criteria:\n\n* Died\n* Living abroad\n* Previously declined to be contacted for future research purposes\n\nReference cohort:\n\nInclusion Criteria:\n\n* Participated in the reference cohort previously established by Holbæk Hospital during year 2010-2016.\n* Age 5-17 at inclusion in reference cohort\n* Age 18-30 years at invitation to follow-up\n\nExclusion Criteria:\n\n* Died\n* Living abroad\n* Previously declined to be contacted for future research purposes",true,"ALL","7 Years","30 Years",{"count":172,"type":173},6100,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the long-term effects on health and well-being of treatment for overweight in childhood or adolescence using the Children's Obesity Clinic Treatment protocol (the Holbæk Model) (HM).\n\nThe study has two parts:\n\n* An active follow-up study, where participants are invited to take part in new measurements and questionnaires\n* A register-based study, which uses existing data on diagnoses, medication use, and school well-being The submitted protocol primarily focuses on the active follow-up study. The register-based study covers diagnoses, medication use, and school-related well-being and is described in the section \"Detailed description\".\n\nIn the active follow-up study, researchers will examine:\n\n* Body measurements such as height, weight, and waist circumference\n* Body composition\n* Psychosocial well-being and mental health\n* Eating behaviors in young adults Participants will be followed for up to 20 years after treatment initiation. Where possible, results will be compared with a group of people of the same age from the same area who did not receive this treatment. This will help show whether their development differs from that of the general population.\n\nThe aim is to use the findings to improve future follow-up care and support for people who were treated for overweight as children.\n\nThe study includes two groups:\n\n1. A treatment group of individuals treated at the Holbæk Pediatric Department between 2008 and 2025\n2. A comparison group from the general population, recruited between 2010 and 2016\n\nThe study will take place in two phases:\n\n* A pilot phase (about 1.5 years) to test procedures and recruitment\n* A main phase (about 3 years)\n\nParticipants are invited to one follow-up visit. During this visit:\n\n* Body measurements will be taken\n* Body composition will be assessed\n* Participants will complete questionnaires The study team will ensure that all participants are treated respectfully and without stigma. Flexible options, including home visits, are offered to make participation easier.",[177],"Overweight , Obesity",[179,180,181,182,183,184],"pediatric obesity","obesity treatment","long-term health","behavioural treatment","long-term follow-up","well-being","NOT_YET_RECRUITING","2026-09-30",{"date":188,"type":189},"2026-10-05","ACTUAL",{"date":191,"type":173},"2026-09",{"date":193,"type":173},"2039-12",{"name":151,"class":6}]