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Sponsor: University of Lisbon
Conditions: Bladder-Bowel Dysfunction, Obesity & Overweight
Interventions: Target physiotherapy, Exercise support intervention, Usual obesity care
Countries: Portugal
Bladder and bowel dysfunction (BBD) is a common condition that includes problems such as urinary urgency, daytime urinary incontinence, bedwetting, constipation, or difficulties emptying the bladder or bowel. These symptoms can negatively affect quality of life, emotional well-being, school participation, and social relationships. Adolescents with obesity may be at a higher risk of developing BBD, but few studies have evaluated effective treatments specifically for this population. The OBE-BBD trial is a randomized controlled study designed to evaluate whether two different non-drug interventions can improve bladder and bowel symptoms in adolescents with obesity when added to standard obesity care. Adolescents aged 13 to 18 years receiving treatment for obesity at the Pediatric Outpatient Clinic of Hospital de Santa Maria (Lisbon, Portugal) will be randomly assigned to one of three groups: (i)Target physiotherapy, consisting of individualized urotherapy and bowel-management education combined with pelvic floor muscle training, breathing exercises, lumbopelvic mobility exercises, stretching, strengthening exercises, and a structured home exercise program; (ii) Exercise support intervention, consisting of supervised physical exercise sessions and a standardized home-based high-intensity interval training (HIIT) program designed for adolescents with obesity; or (iii) Usual care, consisting of the standard multidisciplinary obesity treatment provided at the clinic. Both intervention programs will last 12 weeks. Participants will be assessed before the intervention, immediately after the 12-week intervention period, and again 3 months later. The main objective is to determine whether either intervention reduces the severity of bladder and bowel dysfunction symptoms compared with usual care. The study will also examine whether the interventions improve urinary symptoms, constipation, urinary tract infections, quality of life, psychological well-being, physical activity, sedentary behavior, sleep, dietary habits, and obesity-related outcomes. In addition, the study will investigate whether changes in lifestyle behaviors and obesity-related measures help explain improvements in bladder and bowel symptoms. The results of this study are expected to provide new evidence on effective, non-pharmacological treatment strategies for adolescents with obesity and bladder-bowel dysfunction and may support more comprehensive, multidisciplinary care for this population.
Sex: ALL
Age: 13 Years to 18 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Male or female adolescents aged 13 to 18 years. * Obesity defined as BMI z-score ≥2, according to the WHO growth reference for school-aged children and adolescents. * Currently receiving obesity treatment at the Pediatric Outpatient Clinic, Department of Pediatrics, Hospital de Santa Maria, Unidade Local de Saúde de Santa Maria, Lisbon, Portugal. * Able to understand the study procedures and comply with study requirements. * Written informed consent provided by a parent or legal guardian. * Written assent provided by the adolescent. Exclusion Criteria: * Known neurological disorder affecting bladder or bowel function. * Structural urinary tract or gastrointestinal malformation. * Previous pelvic surgery affecting urinary or bowel continence. * Diabetes mellitus or uncontrolled endocrine or monogenic disorders affecting obesity or bladder/bowel function. * Severe psychiatric disorder requiring immediate specialized treatment and likely to interfere with study participation or adherence. * Major orthopedic or musculoskeletal condition preventing safe participation in the exercise intervention. * Current participation in another interventional clinical trial.
- Lisbon, Portugal