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.
Inclusion Criteria:
Exclusion Criteria:
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Due to the nature of the interventions, participants, intervention providers, and investigators responsible for recruitment and intervention delivery cannot be blinded to treatment allocation. However, participants will not be informed of their baseline bladder-bowel dysfunction (BBD) classification unless clinically necessary. Outcome assessors will remain blinded to group allocation whenever feasible, and participants will be instructed not to disclose their assigned intervention during outcome assessments. Data analyses will be performed using de-identified datasets, and data analysts will remain blinded to treatment allocation until completion of the primary analyses whenever feasible.
Participants will receive the clinic's standard multidisciplinary obesity care together with a 12-week target physiotherapy program integrating standard urotherapy, bowel-management education, pelvic floor muscle training, diaphragmatic breathing, lumbo-pelvic mobility exercises, stretching and strengthening exercises, supervised physiotherapy sessions, and a structured home exercise program.
Participants will receive the clinic's standard multidisciplinary obesity care together with a 12-week exercise support intervention consisting of supervised exercise sessions and a standardized home-based high-intensity interval training (HIIT) program designed for adolescents with obesity. The intervention reinforces adherence to physical activity recommendations but does not include bladder-bowel dysfunction education or urotherapy.
Participants will receive the standard multidisciplinary obesity management routinely provided at the Pediatric Outpatient Clinic, including follow-up with a pediatrician, nutritionist, and exercise physiologist, with counseling on healthy eating and physical activity according to routine clinical practice.
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Multidisciplinary Ambulatory Intervention Program in Family of Children and Adolescents With Obesity
Overweight and Obesity in Adolescents - Sleep Behavioral Intervention
APOLO-Teens, a Web-based Intervention For Adolescents With Overweight/Obesity
Effects of Exercise Intensity in Obese Children and Adolescents
Physical Exercise in Obesity for Health and Quality of Life.
An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents