Healthy Weight for Teens

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939494
• Other study ID #: 2018-4028
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: June 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Telehealth Encounter
Contact will be made with participants via Face Time or Skype.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Helen DeVos Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants Completing Six Month Treatment Period	Completion of the 6 month treatment period will be tracked.	6 months
Secondary	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
Secondary	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
Secondary	Change in Percentage of Body Fat	The health outcome to be evaluated is change in percent body fat (%).	6 months
Secondary	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
Secondary	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
Secondary	Improvement in Lab Values for Serum ALT	The health outcome to be evaluated is the change in the lab value of ALT	6 months
Secondary	Change in Triglyceride	Change in triglyceride levels from baseline to 6 months in intervention vs control group participants	6 months
Secondary	Change in Hba1C Levels	Change in Hba1C from baseline to 6 month visit in intervention vs control group	6 months
Secondary	Change in Non-HDL Cholesterol	Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants	6 months
Secondary	Change in Fasting Glucose	Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants	6 months
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.	Attendance of participants in each group at 3 month follow up visit	3 months
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.	Attendance of participants in each group at 6 month follow up visit	6 months