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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Healthy Weight for Teens

Clinicaltrials.gov identifier NCT03939494

Recruitment Status Completed

First Posted May 6, 2019

Last update posted February 2, 2021

Study Description

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.

  • Condition or Disease:Obesity
  • Intervention/Treatment: Behavioral: Telehealth Encounter
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Enhancing Effectiveness Of Existing Weight Management Programs For Teens With Severe Obesity: A 6-Month Feasibility Pilot
  • Actual Study Start Date: July 2018
  • Actual Primary Completion Date: June 2020
  • Actual Study Completion Date: December 2020
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 1. Test whether existing multi-component PWM programs can successfully implement the BPE for adolescents with severe obesity using existing clinical staff. [ Time Frame: 2 years ]
    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.
  • 2. Evaluate rates of retention and attrition among intervention group as compared to the control group. participants in the Intervention group [ Time Frame: 2 years ]
    Completion of the 6 month treatment period will be tracked.
  • Secondary Outcome Measures: 1. 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. [ Time Frame: 2 years ]
    Attendance at scheduled clinic visits will be tracked during the 6 month treatment period.
  • 2. Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period. [ Time Frame: 2 years ]
    The health outcome to be evaluated is change in percent of the 95th percentile for body mass index.
  • 3. Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period. [ Time Frame: 2 years ]
    The health outcome to be evaluated is change in percent body fat (%).
  • 4. Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period. [ Time Frame: 2 years ]
    The health outcome to be evaluated is change in skeletal muscle mass (kg).
  • 5. Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period. [ Time Frame: 2 years ]
    The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg).
  • 6. Test whether participants in the Intervention group have better health outcomes when compared to participants in the Control group after the 6-month treatment period. [ Time Frame: 2 years ]
    The health outcome to be evaluated is change in lab values including HbA1C, ALT, non-HDL cholesterol, triglycerides and fasting glucose.
Eligibility Criteria
  • Ages Eligible for Study: 12 to 18 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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)

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Helen DeVos Children's Hospital

More Information
  • Responsible Party: Children's Hospital Medical Center, Cincinnati
  • ClinicalTrials.gov Identifier: NCT03939494 History of Changes
  • Other Study ID Numbers: 2018-4028
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: February 2, 2021
  • Last Verified: January 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Obesity