Enhancing Effectiveness Of Existing Weight Management Programs For Teens With Severe Obesity: A 6-Month Feasibility Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Number of Participants Completing Six Month Treatment Period
研究概览
简要总结
POWER is uniquely positioned to evaluate characteristics of multi-component PWM programs that are associated with "favorable" health outcomes for treatment-seeking youth with obesity. The POWER Data Coordinating Center developed ranking reports of the 33 participating sites based on weight status change at 6 months. An in-depth review of program design of 4 "top-performing" sites was conducted. A unique feature identified was offering an individual program orientation session to patient-families prior to the start of the multi-component PWM program. This orientation helped patient-families better understand the program's expectations, and offered an opportunity to evaluate readiness to change, barriers for making lifestyle changes, and mental health problems. This information was used to tailor the intervention to better meet the needs of participating patient-families. When a survey of program characteristics was conducted of the 33 participating sites, this "top-performing site" was the only one to offer such a program orientation session prior to patient-families starting the PWM program. Therefore this program feature was included as part of the "bundle of program enhancements" (BPE) for this proposed pragmatic pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •≥ 12 years of age and < 18
- •Scheduled for a new patient clinic visit at the multi-component PWM program at CCHMC or HDVCH
- •Severe obesity (≥ 120% of the 95th percentile for BMI based on age and gender at time of screening visit)
- •Able to understand and complete the consent process
- •Have access to a smart phone, device, or computer with a web camera
- •Have access to the internet
排除标准
- •Lacking capacity to provide informed consent
- •Non-English speaking
- •Participating in any other weight management program or research study related to weight management
- •Have a sibling participating in any other weight management program or research study related to weight management
- •Taking anti-obesity medication (Phentermine, Orlistat, Qsymia, Naltrxone-Bupropion, Lorcaserin, others at the discretion of the PI)
结局指标
主要结局
Number of Participants Completing Six Month Treatment Period
时间窗: 6 months
Completion of the 6 month treatment period will be tracked.
Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs
时间窗: 6 months
Successful implementation of a "bundle of program enhancements" by existing clinical staff within existing pediatric weight management programs. This success will be defined by ≥80% of randomized intervention group participants and their parent/guardian attending the individual program orientation prior to their initial medical assessment as part of the pediatric weight management program and completing the interactive remote follow-up encounters to achieve the 26 provider contact hours in combination with time spent at clinic visits over the 6 month treatment period.
次要结局
- Change in Hba1C Levels(6 months)
- Change in Non-HDL Cholesterol(6 months)
- Participation Rates in Clinic Visits and Group Sessions(Baseline to 6 months)
- Change in Percent of the 95th Percentile for Body Mass Index(6 months)
- Improvement in Systolic and Diastolic Blood Pressure(6 months)
- Change in Triglyceride(6 months)
- Change in Fasting Glucose(6 months)
- Test Whether the Intervention Group Has Greater Rates of Participation and Retention in Standard-of-care Clinic Visits and Group Sessions (if Offered) Compared to the Control Group.(6 months)
- Change in Percentage of Body Fat(6 months)
- Skeletal Muscle Mass Improvement Over Time(6 months)
- Improvement in Lab Values for Serum ALT(6 months)