N/A
N=61
Healthy Weight for Teens
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03939494 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs — 20; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telehealth Encounter (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs |
20; 12 | — |
| PRIMARY Number of Participants Completing Six Month Treatment Period |
20; 12 | — |
| SECONDARY Participation Rates in Clinic Visits and Group Sessions |
37; 21 | — |
| SECONDARY Change in Percent of the 95th Percentile for Body Mass Index |
-1.07; -2.35 | — |
| SECONDARY Change in Percentage of Body Fat |
0.4; 0.10 | — |
| SECONDARY Skeletal Muscle Mass Improvement Over Time |
0.8; 0.80 | — |
| SECONDARY Improvement in Systolic and Diastolic Blood Pressure |
2.0; 2.0; 2.0; -6.0 | — |
| SECONDARY Improvement in Lab Values for Serum ALT |
2.00; 2.00 | — |
| SECONDARY Change in Triglyceride |
-1.00; -4.00 | — |
| SECONDARY Change in Hba1C Levels |
-0.05; 0.15 | — |
| SECONDARY Change in Non-HDL Cholesterol |
0.00; 9.00 | — |
| SECONDARY Change in Fasting Glucose |
-3.00; 7.00 | — |
| SECONDARY 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. |
16; 12 | — |
| SECONDARY 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. |
16; 12 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03939494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.