Clinical trial NCT03939494: Healthy Weight for Teens
Official title: Enhancing Effectiveness Of Existing Weight Management Programs For Teens With Severe Obesity: A 6-Month Feasibility Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Helen DeVos Children's Hospital
First posted: 2019-05-06
Enrollment: 61
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs
timeFrame: 6 months
measure: Number of Participants Completing Six Month Treatment Period
timeFrame: 6 months
Secondary outcomes:
measure: Participation Rates in Clinic Visits and Group Sessions
timeFrame: Baseline to 6 months
measure: Change in Percent of the 95th Percentile for Body Mass Index
timeFrame: 6 months
measure: Change in Percentage of Body Fat
timeFrame: 6 months
measure: Skeletal Muscle Mass Improvement Over Time
timeFrame: 6 months
measure: Improvement in Systolic and Diastolic Blood Pressure
timeFrame: 6 months
measure: Improvement in Lab Values for Serum ALT
timeFrame: 6 months
measure: Change in Triglyceride
timeFrame: 6 months
measure: Change in Hba1C Levels
timeFrame: 6 months
measure: Change in Non-HDL Cholesterol
timeFrame: 6 months
measure: Change in Fasting Glucose
timeFrame: 6 months
measure: 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.
timeFrame: 3 months
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Indiana
Study officials:
References: