Healthy Weight for Teens

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Enhancing Effectiveness Of Existing Weight Management Programs For Teens With Severe Obesity: A 6-Month Feasibility Pilot

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Telehealth Encounter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 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 Exclusion Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth Intervention<br>This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care. | Behavioral: Telehealth Encounter<br>* Contact will be made with participants via Face Time or Skype.<br>|
| No Intervention: Standard of Care Control<br>This arm will participate in their normal clinic/program routine. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test whether existing multi-component PWM programs can successfully implement the BPE for adolescents with severe obesity using existing clinical staff. | 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. | 2 years | 
| Evaluate rates of retention and attrition among intervention group as compared to the control group. participants in the Intervention group | Completion of the 6 month treatment period will be tracked. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Attendance at scheduled clinic visits will be tracked during the 6 month treatment period. | 2 years | 
| Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period. | The health outcome to be evaluated is change in percent of the 95th percentile for body mass index. | 2 years | 
| Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period. | The health outcome to be evaluated is change in percent body fat (%). | 2 years | 
| Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period. | The health outcome to be evaluated is change in skeletal muscle mass (kg). | 2 years | 
| Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period. | The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg). | 2 years | 
| Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period. | The health outcome to be evaluated is change in lab values including HbA1C, ALT, non-HDL cholesterol, triglycerides and fasting glucose. | 2 years |