[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100425766":3},{"organization":4,"outcomesModule":7,"designInfo":90,"detailedDescription":89,"studyPopulation":89,"armGroups":101,"interventions":115,"overallOfficials":89,"centralContacts":131,"locations":137,"responsibleParty":164,"collaborators":168,"id":170,"slug":89,"hasResults":171,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":89,"eligibilityCriteria":175,"healthyVolunteers":171,"sex":176,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":89,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":139,"whyStopped":89,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},{"fullName":5,"class":6},"Vrije Universiteit Brussel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":89},[9,13],{"measure":10,"description":11,"timeFrame":12},"Brief Pain inventory (BPI)","Questionnaire for assessing clinical pain","Change from baseline to 6 months (T3) after therapy completion",{"measure":10,"description":11,"timeFrame":14},"Difference between groups at 6 months (T3) after therapy completion",[16,18,20,22,24,28,30,31,32,35,36,37,41,42,43,47,48,49,52,53,54,57,58,59,62,63,64,65,68,69,70,71,74,75,76,77,80,81,82,83,86,87,88],{"measure":10,"description":11,"timeFrame":17},"Baseline assessment (T0)",{"measure":10,"description":11,"timeFrame":19},"T1 assessment directly post treatment (i.e. 10 weeks after baseline)",{"measure":10,"description":11,"timeFrame":21},"T2-assessment 3 months after therapy completion",{"measure":10,"description":11,"timeFrame":23},"T3-assessment 6 months after therapy completion",{"measure":25,"description":26,"timeFrame":27},"Central sensitization inventory (CSI)","Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.","Baseline Assessment (T0)",{"measure":25,"description":26,"timeFrame":29},"T1-assessment directly post-treatment (i.e. 10 weeks after baseline)",{"measure":25,"description":26,"timeFrame":21},{"measure":25,"description":26,"timeFrame":23},{"measure":33,"description":34,"timeFrame":17},"TANITA Bio-electrical Impedance Analyzer","Body weight measurement used to calculate BMI (= weight\\[kg\\] \u002F height\\[m\\]²)",{"measure":33,"description":34,"timeFrame":29},{"measure":33,"description":34,"timeFrame":23},{"measure":38,"description":39,"timeFrame":40},"SECA wall-fixed SECA wall-fixed stadiometer","Body height measurement used to calculate BMI (= weight\\[kg\\] \u002F height\\[m\\]²)","Baseline measurement",{"measure":38,"description":39,"timeFrame":29},{"measure":38,"description":39,"timeFrame":23},{"measure":44,"description":45,"timeFrame":46},"TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat","Body composition measurement - body fat","Baseline",{"measure":44,"description":45,"timeFrame":29},{"measure":44,"description":45,"timeFrame":23},{"measure":50,"description":51,"timeFrame":46},"TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass","Body composition measurement - fat free mass",{"measure":50,"description":51,"timeFrame":29},{"measure":50,"description":51,"timeFrame":23},{"measure":55,"description":56,"timeFrame":46},"TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status","Body composition measurement - hydration status",{"measure":55,"description":56,"timeFrame":29},{"measure":55,"description":56,"timeFrame":23},{"measure":60,"description":61,"timeFrame":46},"Food Frequency Questionnaire","Self report questionnaire to asses dietary intake",{"measure":60,"description":61,"timeFrame":29},{"measure":60,"description":61,"timeFrame":21},{"measure":60,"description":61,"timeFrame":23},{"measure":66,"description":67,"timeFrame":46},"International Physical Activity Questionnaire (IPAQ)","Self report questionnaire to asses physical activity",{"measure":66,"description":67,"timeFrame":29},{"measure":66,"description":67,"timeFrame":21},{"measure":66,"description":67,"timeFrame":23},{"measure":72,"description":73,"timeFrame":46},"Sedentary Behavior Questionnaire of Busschaert et a","Self report questionnaire to asses sedentary behavior",{"measure":72,"description":73,"timeFrame":29},{"measure":72,"description":73,"timeFrame":21},{"measure":72,"description":73,"timeFrame":23},{"measure":78,"description":79,"timeFrame":46},"The Short Form Health Survey-36 items (SF-36)","Self report questionnaire to evaluate functional status and well-being or quality of life",{"measure":78,"description":79,"timeFrame":29},{"measure":78,"description":79,"timeFrame":21},{"measure":78,"description":79,"timeFrame":23},{"measure":84,"description":85,"timeFrame":46},"Fear avoidance Beliefs Questionnaire","Self report questionnaire to evaluate fear avoidance beliefs. Total score: 0 - 96 (min-max) Work Subscore: 0 - 66 (min-max) Physical Activity Subscore: 0 - 30 (min-max) Higher scores indicate more fear, pain and disability.",{"measure":84,"description":85,"timeFrame":29},{"measure":84,"description":85,"timeFrame":21},{"measure":84,"description":85,"timeFrame":23},null,{"allocation":91,"interventionModel":92,"interventionModelDescription":93,"primaryPurpose":94,"observationalModel":89,"timePerspective":89,"maskingInfo":95},"RANDOMIZED","PARALLEL","Randomized controlled clinical trial, including two comparative, balanced online treatment arms.","TREATMENT",{"masking":96,"maskingDescription":89,"whoMasked":97},"TRIPLE",[98,99,100],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[102,110],{"label":103,"type":104,"description":105,"interventionNames":106},"Experimental intervention","EXPERIMENTAL","10 weeks blended therapy delivered using a blended approach. The blended (online and on site) therapy consists of instructive video's, challenges to complete, 1-on-1 sessions with the therapist, online quizzes, online booklets, and online diaries\u002Fworkbooks. . The experimental group will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. The combined therapy will adhere to guidelines for patient-centered care",[107,108,109],"Behavioral: Pain Neuroscience Education","Behavioral: Cognition-targeted exercise therapy","Behavioral: Behavioral weight reduction program",{"label":111,"type":112,"description":113,"interventionNames":114},"Control intervention","ACTIVE_COMPARATOR","Identically to the experimental intervention, the therapy is provided in a blended format within 10 weeks. Also identical to the experimental intervention, the control intervention will adhere to guidelines for patient-centered care. The control group will receive pain neuroscience education in combination with cognition-targeted exercise therapy alone.",[107,108],[116,123,127],{"type":117,"name":118,"description":119,"armGroupLabels":120,"otherNames":121},"BEHAVIORAL","Pain Neuroscience Education","Increase pain coping skills and educating the patients that pain is in the brain, and that hypersensitivity of the central nervous system rather than local tissue damage contributes to their symptoms.",[111,103],[122],"Pain Education",{"type":117,"name":124,"description":125,"armGroupLabels":126,"otherNames":89},"Cognition-targeted exercise therapy","Daily (physical) activity and exercise therapy. To confront the patient with movements and activities that are feared, avoided and\u002For painful using a gradual and cognition-targeted approach.",[111,103],{"type":117,"name":128,"description":129,"armGroupLabels":130,"otherNames":89},"Behavioral weight reduction program","Changes in diet, behavior and a physical exercise to reach weight loss. It will include a lifestyle approach, incorporating behavioral theories and constructs to assist and facilitate healthy energy balance related behavior.",[103],[132],{"name":133,"role":134,"phone":135,"phoneExt":89,"email":136},"Anneleen Malfliet, PhD","CONTACT","003224774503","anneleen.malfliet@vub.be",[138,151],{"facility":5,"status":139,"city":140,"state":89,"zip":89,"country":141,"countryCode":142,"cosmosGeoPoint":143,"geoPoint":148,"contacts":149},"RECRUITING","Brussels","Belgium","BE",{"type":144,"coordinates":145},"Point",[146,147],4.34878,50.85045,{"lat":147,"lon":146},[150],{"name":133,"role":134,"phone":89,"phoneExt":89,"email":136},{"facility":152,"status":139,"city":153,"state":89,"zip":89,"country":154,"countryCode":155,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Rotterdam University of Applied Sciences","Rotterdam","Netherlands","NL",{"type":144,"coordinates":157},[158,159],4.47917,51.9225,{"lat":159,"lon":158},[162],{"name":163,"role":134,"phone":89,"phoneExt":89,"email":89},"Lennard Voogt, PhD",{"type":165,"investigatorFullName":166,"investigatorTitle":167,"investigatorAffiliation":5,"oldNameTitle":89,"oldOrganization":89},"PRINCIPAL_INVESTIGATOR","Malfliet Anneleen","Prof. Dr. Anneleen Malfiet",[169],{"name":152,"class":6},"100425766",false,"NCT04824248","Weight Reduction in CLBP","The Added Value of a Behavioral Weight Reduction Program to Blended Rehabilitation in Patients With Chronic Low Back Pain: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Overweight (BMI ≥ 25 kg\u002Fm2) or obese (BMI ≥ 30 kg\u002Fm2) with chronic low back pain\n* Non-specific low back pain for at least 3 months' duration\n* Currently seeking care for low back pain\n* Native Dutch speaker\n* Access to internet and computer\u002Ftablet\u002Fsmartphone\n\nExclusion Criteria:\n\n* Leg pain of 7 or higher (on a maximum of 10) on a numeric rating scale\n* Evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy)\n* Evidence of a severe underlying comorbidity (e.g. diabetes, cardiovascular problems, metabolic diseases)\n* BMI ≥ 40 kg\u002Fm2\n* Being pregnant or given birth in the preceding year\n* Currently receiving dietary or exercise interventions","ALL","18 Years","65 Years",{"count":180,"type":181},84,"ESTIMATED","INTERVENTIONAL",[184],"NA","We will recruit overweight\u002F obese participants between the age of 18 and 65 with chronic nonspecific low back pain . The participants will be randomly assigned to one of two interventions (each lasting 10 weeks). All interventions will be delivered in a blended format and will be a combination of online education material and face-to-face sessions with a physical therapist. The first group (experimental intervention) will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. Participants in the second group (control intervention) will receive pain neuroscience education and cognition-targeted exercise therapy alone. Allocation to the groups will be at random. Participants and assessors will be blinded for group allocation. The primary outcomes is pain intensity. Secondary outcomes include other pain related outcomes, body composition, physical activity, sedentary behavior, dietary intake and function.",[187,188],"Chronic Low-back Pain","Overweight or Obesity",[190,191,192,193,194,195],"chronic low back pain","chronic pain","physiotherapy","physical therapy","weight reduction","pain management","2025-05-20",{"date":198,"type":199},"2025-05-25","ACTUAL",{"date":201,"type":199},"2025-05-01",{"date":203,"type":181},"2026-12-01",{"name":5,"class":6},2]