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NCT03508622

Group Telehealth Weight Management Visits for Adolescents With Obesity

Completed NA Results posted Last updated 9 September 2025
What this trial tests

NA trial testing Telehealth group sessions in Obesity, Childhood in 66 participants. Completed in 1 May 2021.

Timeline
1 January 2018
Primary endpoint
9 April 2021
1 May 2021

Quick facts

Lead sponsorChildren's Hospital Los Angeles
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment66
Start date1 January 2018
Primary completion9 April 2021
Estimated completion1 May 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital Los Angeles

Who can join

Adults 14 to 18, any sex, with Obesity, Childhood. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change From Baseline to 6 Months in Body Mass Index Primary · Baseline to 6 Months

A measure for body adiposity calculated by dividing a participant's weight in kilograms by the square of their height in meters (kg/m\^2)

GroupValue95% CI
Experimental - Telehealth1.07± 2.06
Control - EMPOWER Clinic0.17± 1.43
Mean Change From Baseline to 6 Months in Percentage of 95th Percentile Body Mass Index Primary · Baseline to 6 Months

A measure of body adiposity for severe obesity calculated by dividing a participant's weight in kilograms by the square of their height in meters (kg/m\^2) and categorized as per the American Academy of Pediatrics

GroupValue95% CI
Experimental - Telehealth1.62± 6.84
Control - EMPOWER Clinic-2.52± 4.66
Mean Change From Baseline to 6 Months in Glycosylated Hemoglobin Primary · Baseline to 6 Months

a blood test that measures the average blood glucose over three months

GroupValue95% CI
Experimental - Telehealth-0.27± .85
Control - EMPOWER Clinic-.16± 0.24
Mean Change From Baseline to 6 Months in Alanine Aminotransferase Primary · Baseline to 6 Months

Alanine Aminotransferase (ALT) will be assessed via blood test measured in units/liter. The range from 7 to 56 units per liter (U/L) of blood indicates normal levels and, 57 and greater indicate elevated levels.

GroupValue95% CI
Experimental - Telehealth18.8± 156.00
Control - EMPOWER Clinic3.00± 24.6
Mean Change in Triglycerides From Baseline to 6 Months Primary · Baseline to 6 Months

Triglycerides will be assessed via blood tests and measured in milligrams per deciliter (mg/dL).

GroupValue95% CI
Experimental - Telehealth-7.2± 70.31
Control - EMPOWER Clinic-44.71± 124.13
Mean Change in Diastolic Blood Pressure From Baseline to 6 Months Primary · Baseline to 6 Months

Blood pressure will be assessed via a blood pressure monitor (a device used to measure blood pressure) measured in millimeters of mercury (mmHg). Systolic mmHg less than 70 indicates normal level, above 70 indicates elevated level, and Diastolic mmHg less than 120 indicates normal level, and above 120 indicates elevated level.

GroupValue95% CI
Experimental - Telehealth-2.47± 6.8
Control - EMPOWER Clinic-2.88± 9.81
Mean Change in Systolic Blood Pressure From Baseline to 6 Months Primary · Baseline to 6 Months

Blood pressure will be assessed via a blood pressure monitor (a device used to measure blood pressure) measured in millimeters of mercury (mmHg). Systolic mmHg less than 70 indicates normal level, above 70 indicates elevated level, and Diastolic mmHg less than 120 indicates normal level, and above 120 indicates elevated level.

GroupValue95% CI
Experimental - Telehealth4.1± 10.1
Control - EMPOWER Clinic-4.82± 9.74
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1 Secondary · Baseline to 6 Months

Quality of life measurements will be obtained will be obtained through "Youth Telehealth Pilot Study Survey" questionnaire. Questionnaire with a scale from 1 (only a little), 3 (some) to 5 (a lot). Mean will be provided to describe change.

treated the same as everyone else?
GroupValue95% CI
Experimental - Telehealth0.7± 0.7
accepted just as you are?
GroupValue95% CI
Experimental - Telehealth0± 1
challenged and encouraged through sports?
GroupValue95% CI
Experimental - Telehealth0.4± 1.3
successful or skilled in some sport or other activity you like?
GroupValue95% CI
Experimental - Telehealth0.7± 0.6
happy with yourself?
GroupValue95% CI
Experimental - Telehealth0± 0.7
able to speak up for yourself?
GroupValue95% CI
Experimental - Telehealth0.9± 1.1
satisfied with your school day?
GroupValue95% CI
Experimental - Telehealth0.1± 1.1
able to take part in group activities?
GroupValue95% CI
Experimental - Telehealth1.0± 1.6
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire. Secondary · Baseline to 6 Months

Quality of Life measurements will be obtained through will be obtained through "Youth Telehealth Pilot Study Survey" questionnaire. Questions 1-13 on questionnaire use a scale from 1 to 5 with 1) Never, 2) Rarely, 3) Sometimes, 4) Often, 5) All the time. Question 14 uses scale from 1 to 5 with 1) Not at all, 2) Somewhat severe , 3) Moderately severe , 4) Fairly, 5) Very Severe. Question 15 on questionnaire use a scale from 1 to 5 with 1) not at all 2) Somewhat 3) Moderately, 4)A lot, 5) Really a lot

During the past week I felt so big that it was hard to move.
GroupValue95% CI
Control - EMPOWER Clinic0.06± 0.42
I got tired and out of breath quickly compared to others when being physically active.
GroupValue95% CI
Control - EMPOWER Clinic-0.12± 0.76
During the past week I was sad and depressed because of my weight
GroupValue95% CI
Control - EMPOWER Clinic-0.12± 0.90
During the past week I was annoyed by my many attempts at losing weight
GroupValue95% CI
Control - EMPOWER Clinic-0.88± 1.08
During the past week I felt ashamed because of my weight
GroupValue95% CI
Control - EMPOWER Clinic-.35± 0.97
During the past week was dissatisfied with myself because of my weight
GroupValue95% CI
Control - EMPOWER Clinic-0.59± 1.19
During the past week my family scolded me because of my weight
GroupValue95% CI
Control - EMPOWER Clinic-0.47± 1.72
During the past week had to eat at home because I'm watching my weight
GroupValue95% CI
Control - EMPOWER Clinic0.12± 1.32
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire Secondary · 6 Months

Satisfaction measurements will be obtained through "Satisfaction using Telehealth" questionnaire.

I felt comfortable using technology for my online sessions.
GroupValue95% CI
Experimental - Telehealth13
Experimental - Telehealth4
Experimental - Telehealth0
Participating in the TH sessions was much easier than going in person doctor's appointment.
GroupValue95% CI
Experimental - Telehealth10
Experimental - Telehealth7
Experimental - Telehealth0
I would like to have online sessions again.
GroupValue95% CI
Experimental - Telehealth8
Experimental - Telehealth9
Experimental - Telehealth0
I liked talking to other teens and young adults during the online sessions.
GroupValue95% CI
Experimental - Telehealth5
Experimental - Telehealth12
Experimental - Telehealth0
I felt supported during the group sessions.
GroupValue95% CI
Experimental - Telehealth14
Experimental - Telehealth3
Experimental - Telehealth0
I felt comfortable asking the session leader questions throughout the online sessions.
GroupValue95% CI
Experimental - Telehealth12
Experimental - Telehealth5
Experimental - Telehealth0
I was able to speak freely and express myself.
GroupValue95% CI
Experimental - Telehealth14
Experimental - Telehealth3
Experimental - Telehealth0
I felt comfortable showing my face with others on screen during the sessions.
GroupValue95% CI
Experimental - Telehealth3
Experimental - Telehealth9
Experimental - Telehealth5
Attendance/Retention From Baseline to 6 Months Secondary · Baseline to 6 Months

Attendance, no-show and same-day reschedules

GroupValue95% CI
Experimental - Telehealth6.91 – 12
Control - EMPOWER Clinic5.55 – 7

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Obesity, Childhood

Currently open trials in the same condition.

Other Children's Hospital Los Angeles trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03508622.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing