Healthy Weight for Teens

NCT03939494 | Completed Results DMC

• 1 other identifier: 2018-4028
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Participation Rates in Clinic Visits and Group Sessions

  Baseline to 6 months

• Change in Percent of the 95th Percentile for Body Mass Index

  6 months

• Change in Percentage of Body Fat

  6 months

• Skeletal Muscle Mass Improvement Over Time

  6 months

• Improvement in Systolic and Diastolic Blood Pressure

  6 months

Study Arms (2)

Telehealth Intervention

EXPERIMENTAL

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

Behavioral: Telehealth Encounter

Standard of Care Control

NO INTERVENTION

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

Interventions

Telehealth Encounter BEHAVIORAL

Contact will be made with participants via Face Time or Skype.

Telehealth Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Helen DeVos Children's Hospital: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Indiana, 45229, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mary Banks
• Organization: Cincinnati Children's Hospital

mary.banks@cchmc.org

513-636-2147

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: May 6, 2019
• Study Start: July 18, 2018
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 12, 2024
• Results First Posted: June 12, 2024

Record last verified: 2024-06

Locations

US (1)