Healthy Weight for Teens

Enhancing Effectiveness Of Existing Weight Management Programs For Teens With Severe Obesity: A 6-Month Feasibility Pilot

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Telehealth Encounter

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Cincinnati, Indiana, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth Intervention; This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.	Behavioral: Telehealth Encounter; Contact will be made with participants via Face Time or Skype.
No Intervention: Standard of Care Control; This arm will participate in their normal clinic/program routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
Number of Participants Completing Six Month Treatment Period	Completion of the 6 month treatment period will be tracked.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months
Change in Percentage of Body Fat	The health outcome to be evaluated is change in percent body fat (%).	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.	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).	6 months
Improvement in Lab Values for Serum ALT	The health outcome to be evaluated is the change in the lab value of ALT	6 months
Change in Triglyceride	Change in triglyceride levels from baseline to 6 months in intervention vs control group participants	6 months
Change in Hba1C Levels	Change in Hba1C from baseline to 6 month visit in intervention vs control group	6 months
Change in Non-HDL Cholesterol	Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants	6 months
Change in Fasting Glucose	Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants	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	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	6 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Helen DeVos Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2018-4028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No