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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Contact will be made with participants via Face Time or Skype.
Cincinnati Children's Hospital Medical Center
Cincinnati, Indiana, United States
Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs
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.
Time frame: 6 months
Number of Participants Completing Six Month Treatment Period
Completion of the 6 month treatment period will be tracked.
Time frame: 6 months
Participation Rates in Clinic Visits and Group Sessions
Attendance of participants in each group throughout study period; from baseline visit through 6 month follow up period.
Time frame: Baseline to 6 months
Change in Percent of the 95th Percentile for Body Mass Index
The health outcome to be evaluated is change in percent of the 95th percentile for body mass index.
Time frame: 6 months
Change in Percentage of Body Fat
The health outcome to be evaluated is change in percent body fat (%).
Time frame: 6 months
Skeletal Muscle Mass Improvement Over Time
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.
Time frame: 6 months
Improvement in Systolic and Diastolic Blood Pressure
The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg).
Time frame: 6 months
Improvement in Lab Values for Serum ALT
The health outcome to be evaluated is the change in the lab value of ALT
Time frame: 6 months
Change in Triglyceride
Change in triglyceride levels from baseline to 6 months in intervention vs control group participants
Time frame: 6 months
Change in Hba1C Levels
Change in Hba1C from baseline to 6 month visit in intervention vs control group
Time frame: 6 months
Change in Non-HDL Cholesterol
Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants
Time frame: 6 months
Change in Fasting Glucose
Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants
Time frame: 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.
Attendance of participants in each group at 3 month follow up visit
Time frame: 3 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.
Attendance of participants in each group at 6 month follow up visit
Time frame: 6 months
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