Healthy Weight for Teens

Not Applicable

Completed

Conditions: Obesity

Interventions: Behavioral: Telehealth Encounter

Registration Number: NCT03939494

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telehealth Intervention	Telehealth Encounter	This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.

Primary Outcome Measures

Name	Time	Method
Number of Participants Completing Six Month Treatment Period	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Hba1C Levels	6 months	Change in Hba1C from baseline to 6 month visit in intervention vs control group
Change in Non-HDL Cholesterol	6 months	Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants
Participation Rates in Clinic Visits and Group Sessions	Baseline to 6 months	Attendance of participants in each group throughout study period; from baseline visit through 6 month follow up period.
Change in Percent of the 95th Percentile for Body Mass Index	6 months	The health outcome to be evaluated is change in percent of the 95th percentile for body mass index.
Improvement in Systolic and Diastolic Blood Pressure	6 months	The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg).
Change in Triglyceride	6 months	Change in triglyceride levels from baseline to 6 months in intervention vs control group participants
Change in Fasting Glucose	6 months	Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants
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	Attendance of participants in each group at 6 month follow up visit
Change in Percentage of Body Fat	6 months	The health outcome to be evaluated is change in percent body fat (%).
Skeletal Muscle Mass Improvement Over Time	6 months	The health outcome to be evaluated is change in skeletal muscle mass (kg). An improvement will be indicated by an increase in skeletal muscle mass.
Improvement in Lab Values for Serum ALT	6 months	The health outcome to be evaluated is the change in the lab value of ALT