Partnering Lifestyle Intervention With Bariatric Surgery to Maximize Health Outcomes in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change in Health-related Quality of Life as Measured by the HRQOL-14
研究概览
简要总结
This study aims to conduct a proof-of-concept study to assess the feasibility, acceptability, and effectiveness of a Metabolic and bariatric surgery (MBS) -supported healthy lifestyle behavioral intervention among adolescent patients, their families, and their clinical team.
详细描述
This proof-of-concept study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a lifestyle behavioral intervention integrated with metabolic and bariatric surgery (MBS) for adolescents with severe obesity. Targeting youth aged 12-18, the intervention is designed to enhance pre- and post-operative outcomes by supporting sustained healthy behaviors among patients and their families. Guided by formative qualitative research (AIM 1), the team will adapt an evidence-based multimedia lifestyle program (AIM 2) to align with adolescent MBS patients' unique needs and preferences.
The adapted intervention will then be pilot-tested (AIM 3) among adolescent patients at a large adolescent healthcare system, with participants followed up to 12 months post-surgery. The program includes online components delivered before and after surgery, with progress evaluated at multiple time points. In addition to anthropometric and cardiometabolic outcomes, the study will assess intervention engagement, satisfaction, and delivery fidelity using the RE-AIM framework. The overarching goal is to demonstrate that combining lifestyle support with MBS can improve adherence, reduce attrition, and enhance long-term health outcomes among adolescents with severe obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must meet National Institutes of Health criteria to qualify for MBS for adolescents (BMI >35 kg/m^2 and at least one existing co-morbidity [e.g. elevated blood pressure, hypercholesterolemia, etc.] or a BMI>40kg/m^2).
- •received psychological clearance for surgery
排除标准
- •is not medically referred by a physician for bariatric surgery
- •Refuses to participate in the study
结局指标
主要结局
Change in Health-related Quality of Life as Measured by the HRQOL-14
时间窗: Pre-surgery, 6 months post-surgery
This survey includes 3 modules (Healthy Days Core Module = 4 questions, Activity Limitations Module = 5 questions, and the Healthy Days Symptoms Module = 5 questions). This survey is not based on a summary score. Instead to evaluate the score unhealthy days are the estimated total number of days in a 30 day period where participants felt their physical or mental health was not good. Survey responses from question 2 and 3 in the Healthy Days Core Module are combined to get overall unhealthy days.
Change in Diastolic Blood Pressure
时间窗: pre surgery, 6 months post surgery
Measure diastolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery.
Change in Health-related Quality of Life as Measured by the HRQOL-14
时间窗: Pre-surgery, 6 months post-surgery
This survey includes 3 modules (Healthy Days Core Module = 4 questions, Activity Limitations Module = 5 questions, and the Healthy Days Symptoms Module = 5 questions). This survey is not based on a summary score. Instead to evaluate the score unhealthy days are the estimated total number of days in a 30 day period where participants felt their physical or mental health was not good. Survey responses from question 2 and 3 in the Healthy Days Core Module are combined to get overall unhealthy days.
Change in Blood Lipid Levels as Assessed by Lipid Panel
时间窗: Pre surgery, 6 months post surgery
Cholesterol (mg/dL), HDL cholesterol (mg/dL), Triglycerides (mg/dL), LDL cholesterol (mg/dL), non-HDL cholesterol (mg/dL) change from pre-surgery to 6 months post-surgery.
Change in Blood Glucose Level
时间窗: pre surgery, 6 months post surgery
Measure of Blood Glucose (mg/dL) change from pre-surgery to 6 months post-surgery.
Change in Diastolic Blood Pressure
时间窗: pre surgery, 6 months post surgery
Measure diastolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery.
Change in Systolic Blood Pressure
时间窗: pre surgery, 6 months post surgery
Measure systolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery.
Change in HbA1c Levels
时间窗: pre surgery, 6 months post surgery
Measure HbA1c% (mmol/mol) levels in blood change from pre-surgery to 6 months post-surgery.
次要结局
未报告次要终点
研究者
Sarah E Messiah
Professor
The University of Texas Health Science Center, Houston