Standardized Tongue Ultrasound Protocol for Tongue Characteristics in Children and Adolescents With Obesity After a 30-week Inpatient Weight Loss Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Tongue stiffness
研究概览
简要总结
This longitudinal observational study aims to validate ultrasound-based tongue markers related to tongue characteristics, including fat accumulation, morphologic and mechanical properties of the tongue in children and adolescents with obesity. Participants are assessed at baseline and after completion of a standardized 30-week inpatient weight-loss rehabilitation program at the Zeepreventorium (De Haan, Belgium). Tongue ultrasound parameters are examined in relation to anthropometric characteristics and obstructive sleep apnea condition.
详细描述
This prospective observational cohort study investigates ultrasound-based tongue characteristics in children and adolescents with obesity. Participants undergo standardized submental tongue ultrasound examinations at baseline and after completion of a 30-week inpatient multidisciplinary weight-loss rehabilitation program.
Ultrasound measures include tongue morphology, fat-related imaging biomarkers, and mechanical properties assessed using shear-wave elastography. Anthropometric data and validated sleep-disordered breathing questionnaires are collected in parallel. Measurement reliability is evaluated, and associations between ultrasound parameters, anthropometric characteristics, and sleep-related outcomes are explored.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and adolescents aged 6 to 18 years
- •Diagnosis of obesity
- •Already enrolled in the inpatient weight-loss rehabilitation program at the Zeepreventorium
- •Written informed consent from legal guardian and assent from the participant, following the legal requirements
排除标准
- •Known orthopedic, traumatic, or rheumatologic conditions affecting the cervicocephalic region
- •Contraindication to ultrasound examination
- •Inability to comply with study procedures
- •Inability to understand the procedures
研究组 & 干预措施
Study group
Children and adolescents with obesity participating in a specialized inpatient multidisciplinary weight-loss rehabilitation program (30 weeks).
As this is an observational study, tongue ultrasound (via a submental approach, a non-invasive, risk-free and harmless procedure) will be performed and basic anthropometric data (height, weight, neck circumference, hydration status) will be collected.
干预措施: Submental ultrasound (Other)
Control group
Healthy children and adolescents. As this is an observational study, tongue ultrasound (via a submental approach, a non-invasive, risk-free and harmless procedure) will be performed and basic anthropometric data (height, weight, neck circumference, hydration status) will be collected.
干预措施: Submental ultrasound (Other)
结局指标
主要结局
Tongue stiffness
时间窗: at baseline and after 30-weeks weight loss program
Tongue stiffness is measured by shear-wave elastography and expressed in kPa.
Intraclass correlation coefficient, ICC
时间窗: Baseline
Intraclass correlation coefficient will be used to assess intra and inter-rater reliability of ultrasound markersUltrasound reliability and repeatability of tongue measurements will be assessed with intraclass correlation coefficients (ICC), along with their 95% confidence intervals. Each ultrasound measurement (tongue size and morphological parameters, echo intensity, stiffness, tissue attenuation imaging, tissue scatter distribution imaging, and fat fraction) in sagittal and coronal planes will be performed twice in fifteen participants by the principal investigator, with a 24-hour interval between examinations.
次要结局
- Tongue thickness(at baseline and after 30 weeks weight loss program)
- Echo Intensity(at baseline and after a 30 weeks weight loss program)
- Tissue Attenuation Imaging index(at baseline and after a 30 weeks weight loss program)
- OSA-18 questionnaire(Baseline and after a 30-weeks weight loss program)
- Weight(baseline and after a 30 weeks weight loss program)
- Height(Baseline and after a 30 weeks weight loss program)
- BMI Z score(Baseline and after a 30-weeks weight loss program)
研究者
Frédéric Paillaugue
Principal Investigator, MSc PT Drs
Haute Ecole Bruxelles-Brabant