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Group Telehealth Weight Management Visits for Adolescents With Obesity

Primary Purpose

Obesity, Childhood

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth group sessions
Empower clinic
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

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.

Sites / Locations

  • Children's Hospital Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Telehealth

Empower

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in anthropometric and clinical data
change in absolute body mass index
Change in anthropometric and clinical data
% of 95th percentile body mass index
Change in anthropometric and clinical data
Labs: Glycosylated Hemoglobin; Hb A1c %
Change in anthropometric and clinical data
Labs: Alanine Aminotransferase; ALT units/L
Change in anthropometric and clinical data
Labs: Triglycerides; mg/dL
Change in anthropometric and clinical data
Blood Pressure; (mm Hg)a

Secondary Outcome Measures

Change in quality of life
Quality of life measurements will be obtained will be obtained through "Youth Telehealth Pilot Study Survey" questionnaire.
Self-efficacy
Self-efficacy measurements will be obtained through will be obtained through "Youth Telehealth Pilot Study Survey" questionnaire.
Satisfaction with care
Satisfaction measurements will be obtained through "Satisfaction using Telehealth" questionnaire.
Attendance/Retention
Attendance, no-show and same-day reschedules will be tallied

Full Information

First Posted
January 6, 2018
Last Updated
July 21, 2023
Sponsor
Children's Hospital Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03508622
Brief Title
Group Telehealth Weight Management Visits for Adolescents With Obesity
Official Title
Group Telehealth Weight Management Visits for Adolescents With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 9, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Summary Description The goal of this intervention study is to test how well does a weight management curriculum work in virtual group-based medical visits (telehealth) for the treatment of adolescents with obesity. The main questions it aims to answer are: How well does providing group-based medical care for obesity using telehealth work? How doable is it to provide virtual group-based health education visits with adolescent patients? Are the group-based health education visits similar, or better than the traditional in-person clinic visits? Participants will be asked to: Complete surveys, do bloodwork, and physical measurements like blood pressure, height and weight before the study activities start and after completing the study activities Participate in study activities such as attending 12 virtual sessions lasting 60 minutes each, every other week, over a period of 6 months Join group learning and discussions of topics like nutrition, barriers to physical activity, and mental health with various facilitators like a medical doctor, dietitian, psychologist, and physical therapist Take part of in brief individual coaching sessions over email or over the phone Researchers will compare the virtual group-based medical visits to the traditional in-person weight management clinic visits (EMPOWER Weight Management Clinic) to see if the study can be another option in the treatment of adolescents with obesity.
Detailed Description
Background As noted above, EMPOWER was a multi-disciplinary, team-based clinic model, involving physicians, psychologists, registered dietitians (RDs), and physical therapists (PTs) providing tertiary care management of obesity. Data from the first two years of EMPOWER showed that patients with four or more visits (n=109) experienced a decrease in average BMI z-score (-0.09SD). This, though modest, is promising; however, both cost and patient retention present significant challenges to EMPOWER and other tertiary care pediatric obesity programs, and may be barriers to further progress. Much administrative personnel time was consumed in working with insurers in order to authorize visits, and nevertheless, this type of hospital-based care was poorly reimbursed. Getting to Children's Hospital Los Angeles (CHLA) is often a major challenge for our patients, due to the large urban sprawl of Los Angeles, traffic, limited and expensive parking, and poor public transportation. Frequent visits result in missed work and school days, a burden to families. Adolescent patients face even greater challenges, as they learn to manage their own health and balance the emotional and social changes required in the transition to adulthood, with family and parental expectations and limitations. Telehealth technology presents an innovative, cost-effective, and often highly-engaging alternative to in-person visits, which bypasses many of the logistical difficulties of getting to CHLA. Moreover, adolescents today are highly attuned to, and aligned with, digital and mobile technologies, and are natural consumers of media in this format. There is strong evidence from numerous published studies that telehealth can be an effective tool for chronic disease management. Additionally, many youth with obesity are significantly socially isolated, and our current individual patient-provider model does not effectively address this isolation in the way we expect a group session will; various published studies of group treatment have demonstrated inter-participant support and positive effects of social interaction. While Empower's current model leads to successful weight management in many of its patients, that success is often modest, as alluded to above; and for some of patients, it simply does not work. With this study, the investigators intend to pilot a group telehealth model targeted at adolescents with obesity. Specifically, the investigators aim to: Pilot a new care delivery model for CHLA EMPOWER patients using group telehealth visits. Assess the feasibility of using telehealth with adolescent patients Test the efficacy of group health education sessions using video conference technology Hypotheses: Use of group health education sessions using video conference technology is a feasible, cost-effective care delivery model for adolescents being treated for obesity. Efficacy of this model will be comparable to, or better than, standard multi-disciplinary in-person visits. This will be measured by: a. Clinical and anthropomorphic data: i. Changes in Body Mass Index (BMI), BMI percentile, and BMI percent of the 95th percentile ii. Change in blood pressure percentile iii. Change in hemoglobin A1C, ALT, triglycerides b. Quality of life c. Self-efficacy d. Satisfaction Attendance to telehealth visits will be better than attendance to standard in-person visits, as measured by no-show rates and same-day reschedules Methods and study design: Youth 14-18 years of age who meet EMPOWER clinic criteria and consent to the study will be prospectively assigned to the intervention telehealth group (n=24); they will be compared to a restrospective cohort of "standard care" EMPOWER patients (n=24). Since the investigators do not expect a statistically significant difference in BMI change between the telehealth intervention and standard EMPOWER, power calculations were conducted on change scores in Quality of Life indicators. Using Optimal Design software v1.77 and specifying a = 0.05, anticipated effect size δ = 0.40, between-group variance ranging around 0.05, and controlling for effects of the covariates on various measures at 3 and 6 months, it is expected that 24 participants per condition will provide a moderate power to identify a treatment effect for proof of concept purposes. The intervention group will receive: Group telehealth sessions twice per month for 6 months. The group sessions will be 60 minutes and involve delivery of a semi-structured curriculum including topics such as nutrition education, reducing barriers to physical activity, and mindfulness techniques. Sessions will be facilitated by EMPOWER providers (physicians, psychologists, RDs, and PTs) who will use a combination of: 1) motivational interviewing techniques, modified for the group setting, 2) supportive exploration of barriers to behavior change and 3) setting SMART goals. Brief individualized coaching by the program coordinator between sessions via telephone or email. It will be comparable to the personalized feedback and motivation provided in standard EMPOWER. Parent newsletters will be sent out monthly to inform parents of key messages; parents will also be informed of their child's attendance to the session Control subjects received the standard EMPOWER model consisting of monthly in person clinic visits where they met individually with a combination of providers (physician, RD, PT, and/or psychologist). The intervention group participants will have in-person visits at baseline, 3 and 6 months to measure weight, vertical growth, and blood pressure, and complete questionnaires assessing quality of life, self-efficacy and satisfaction. Anthropomorphic measures and attendance rates will be compared to the retrospective control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot intervention using retrospective control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telehealth
Arm Type
Experimental
Arm Description
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.
Arm Title
Empower
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth group sessions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Empower clinic
Intervention Description
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 Measure Information:
Title
Change in anthropometric and clinical data
Description
change in absolute body mass index
Time Frame
6 months
Title
Change in anthropometric and clinical data
Description
% of 95th percentile body mass index
Time Frame
6 months
Title
Change in anthropometric and clinical data
Description
Labs: Glycosylated Hemoglobin; Hb A1c %
Time Frame
6 months
Title
Change in anthropometric and clinical data
Description
Labs: Alanine Aminotransferase; ALT units/L
Time Frame
6 months
Title
Change in anthropometric and clinical data
Description
Labs: Triglycerides; mg/dL
Time Frame
6 months
Title
Change in anthropometric and clinical data
Description
Blood Pressure; (mm Hg)a
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
Quality of life measurements will be obtained will be obtained through "Youth Telehealth Pilot Study Survey" questionnaire.
Time Frame
6 months
Title
Self-efficacy
Description
Self-efficacy measurements will be obtained through will be obtained through "Youth Telehealth Pilot Study Survey" questionnaire.
Time Frame
6 months
Title
Satisfaction with care
Description
Satisfaction measurements will be obtained through "Satisfaction using Telehealth" questionnaire.
Time Frame
6 months
Title
Attendance/Retention
Description
Attendance, no-show and same-day reschedules will be tallied
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Class 2 or 3 obesity OR 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: Significant intellectual or neurodevelopmental disability Inability to stand on a scale independently without assistance or use of an assistive device Non-English speaking 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda Manzanarez
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18055651
Citation
Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
Results Reference
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PubMed Identifier
24968105
Citation
Bashshur RL, Shannon GW, Smith BR, Alverson DC, Antoniotti N, Barsan WG, Bashshur N, Brown EM, Coye MJ, Doarn CR, Ferguson S, Grigsby J, Krupinski EA, Kvedar JC, Linkous J, Merrell RC, Nesbitt T, Poropatich R, Rheuban KS, Sanders JH, Watson AR, Weinstein RS, Yellowlees P. The empirical foundations of telemedicine interventions for chronic disease management. Telemed J E Health. 2014 Sep;20(9):769-800. doi: 10.1089/tmj.2014.9981. Epub 2014 Jun 26.
Results Reference
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PubMed Identifier
20197355
Citation
Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2.
Results Reference
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PubMed Identifier
26033508
Citation
Harris MA, Freeman KA, Duke DC. Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Diabetes Care. 2015 Aug;38(8):1427-34. doi: 10.2337/dc14-2469. Epub 2015 Jun 1.
Results Reference
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PubMed Identifier
22150392
Citation
Markowitz JT, Laffel LM. Transitions in care: support group for young adults with Type 1 diabetes. Diabet Med. 2012 Apr;29(4):522-5. doi: 10.1111/j.1464-5491.2011.03537.x.
Results Reference
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PubMed Identifier
26265590
Citation
Kulik N, Ennett ST, Ward DS, Bowling JM, Fisher EB, Tate DF. Brief report: A randomized controlled trial examining peer support and behavioral weight loss treatment. J Adolesc. 2015 Oct;44:117-23. doi: 10.1016/j.adolescence.2015.07.010. Epub 2015 Aug 7.
Results Reference
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PubMed Identifier
27267503
Citation
Tanofsky-Kraff M, Shomaker LB, Young JF, Wilfley DE. Interpersonal psychotherapy for the prevention of excess weight gain and eating disorders: A brief case study. Psychotherapy (Chic). 2016 Jun;53(2):188-94. doi: 10.1037/pst0000051.
Results Reference
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Group Telehealth Weight Management Visits for Adolescents With Obesity

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