Healthy Weight for Teens

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Telehealth Encounter

Study type: Interventional

Funder types: Other

Identifiers

NCT03939494

2018-4028

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Telehealth Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Telehealth Encounter

Standard of Care Control

No Intervention group

Description:

This arm will participate in their normal clinic/program routine.