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OpenTrials
Completed

NCT Number: NCT03939494

Healthy Weight for Teens

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.

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Key information

Conditions

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

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Indiana, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Telehealth Encounter

Behavioral

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

Primary outcomes

  1. Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs

    Time frame: 6 months

    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. Number of Participants Completing Six Month Treatment Period

    Time frame: 6 months

    Completion of the 6 month treatment period will be tracked.

Secondary outcomes

  1. Participation Rates in Clinic Visits and Group Sessions

    Time frame: Baseline to 6 months

    Attendance of participants in each group throughout study period; from baseline visit through 6 month follow up period.

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

    Time frame: 6 months

    The health outcome to be evaluated is change in percent of the 95th percentile for body mass index.

  3. Change in Percentage of Body Fat

    Time frame: 6 months

    The health outcome to be evaluated is change in percent body fat (%).

  4. Skeletal Muscle Mass Improvement Over Time

    Time frame: 6 months

    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.

  5. Improvement in Systolic and Diastolic Blood Pressure

    Time frame: 6 months

    The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg).

  6. Improvement in Lab Values for Serum ALT

    Time frame: 6 months

    The health outcome to be evaluated is the change in the lab value of ALT

  7. Change in Triglyceride

    Time frame: 6 months

    Change in triglyceride levels from baseline to 6 months in intervention vs control group participants

  8. Change in Hba1C Levels

    Time frame: 6 months

    Change in Hba1C from baseline to 6 month visit in intervention vs control group

  9. Change in Non-HDL Cholesterol

    Time frame: 6 months

    Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants

  10. Change in Fasting Glucose

    Time frame: 6 months

    Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants

  11. 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: 3 months

    Attendance of participants in each group at 3 month follow up visit

  12. 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: 6 months

    Attendance of participants in each group at 6 month follow up visit

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Helen DeVos Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 6, 2019
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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