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Group Telehealth Weight Management Visits for Adolescents With Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03508622
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
claudia borzutzky, Children's Hospital Los Angeles

Brief Summary:
This pilot study aims to evaluate the feasibility and efficacy of a group telehealth model, compared with a standard multi-disciplinary, individualized, in-clinic weight management model, for treatment of adolescents with obesity.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Behavioral: Telehealth group sessions Behavioral: Empower clinic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot intervention using retrospective control group.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Group Telehealth Weight Management Visits for Adolescents With Obesity
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Telehealth
This group will receive weight management treatment via 12 online group sessions, over 6 months. They will have Bluetooth-enabled scales that will allow them to transmit their weight data to the PI in between research visits. They will answer questionnaires and have research visits at baseline, 3 months, and 6 months.
Behavioral: Telehealth group sessions
Telehealth sessions will utilize an online meeting platform and will be conducted by RDs, PTs, psychologists, and MDs, to deliver weight management information/counseling, to group of 5-6 14-18 yos with obesity.

Empower
This retrospective control group received standard in-clinic individualized weight management with a multi-disciplinary group of providers, via 6 monthly clinic visits, over 6 months.
Behavioral: Empower clinic
Empower visits for the retrospective control group were multi-disciplinary in nature, occurred at CHLA outpatient clinic, and were intended to be monthly (though actual adherence to recommended attendance was variable). Teen and minimum of one family member were asked to attend monthly visits, as per our standard clinical care.




Primary Outcome Measures :
  1. Change in anthropometric and clinical data [ Time Frame: 6 months ]
    change in absolute body mass index

  2. Change in anthropometric and clinical data [ Time Frame: 6 months ]
    % of 95th percentile body mass index

  3. Change in anthropometric and clinical data [ Time Frame: 6 months ]
    Labs: Glycosylated Hemoglobin; Hb A1c %

  4. Change in anthropometric and clinical data [ Time Frame: 6 months ]
    Labs: Alanine Aminotransferase; ALT units/L

  5. Change in anthropometric and clinical data [ Time Frame: 6 months ]
    Labs: Triglycerides; mg/dL

  6. Change in anthropometric and clinical data [ Time Frame: 6 months ]
    Blood Pressure; (mm Hg)a


Secondary Outcome Measures :
  1. Change in quality of life [ Time Frame: 6 months ]
    Quality of life measurements will be obtained will be obtained through "Youth Telehealth Pilot Study Survey" questionnaire.

  2. Self-efficacy [ Time Frame: 6 months ]
    Self-efficacy measurements will be obtained through will be obtained through "Youth Telehealth Pilot Study Survey" questionnaire.

  3. Satisfaction with care [ Time Frame: 6 months ]
    Satisfaction measurements will be obtained through "Satisfaction using Telehealth" questionnaire.

  4. Attendance/Retention [ Time Frame: 6 months ]
    Attendance, no-show and same-day reschedules will be tallied



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. class 2 or 3 obesity OR
  2. class 1 obesity plus a significant comorbidity, such as impaired glucose tolerance or type 2 diabetes mellitus, hypertension, hyperlipidemia, non-alcoholic fatty liver disease (NAFLD), polycystic ovarian syndrome (PCOS), or obstructive sleep apnea.

Exclusion Criteria:

  1. significant intellectual or neurodevelopmental disability
  2. inability to stand on a scale independently without assistance or use of an assistive device
  3. non-English speaking
  4. baseline weight > 165 kg

Given the shared nature of group appointments, participants should be at approximately the same developmental stage as their peers. Discussion topics may include stigma, body image, family dynamics, and school issues, and therefore a wide variance in age range or cognitive status could potentially diminish the effectiveness of the group sessions. Non-English speaking youth will be excluded due to limitations in translation services for such a small pilot project. English speaking adolescents with non-English speaking parents will be included. Patients must be able to stand on scales on their own in order to generate accurate weight and BMI measurements. Lastly, patients with baseline weight > 165 kg will not be able to participate due to the maximum weight limit on the loaned wifi enabled scales.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508622


Contacts
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Contact: Claudia Borzutzky, MD (323) 361-2153 cborzutzky@chla.usc.edu
Contact: Dalia Salazar (323) 361-1920 bitorres@chla.usc.edu

Locations
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United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Dalia Salazar    323-361-1920    dasalazar@chla.usc.edu   
Contact: Claudia Borzutzky, MD    323-361-2153    cborzutzky@chla.usc.edu   
Principal Investigator: Claudia Borzutzky, MD         
Sub-Investigator: Cassandra Fink, MPH         
Sponsors and Collaborators
Children's Hospital Los Angeles
Publications:

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Responsible Party: claudia borzutzky, Clinical Associate Professor Pediatrics, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT03508622    
Other Study ID Numbers: RGA011089
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms