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 IndexPrimary· 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)
Group
Value
95% CI
Experimental - Telehealth
1.07
± 2.06
Control - EMPOWER Clinic
0.17
± 1.43
Mean Change From Baseline to 6 Months in Percentage of 95th Percentile Body Mass IndexPrimary· 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
Group
Value
95% CI
Experimental - Telehealth
1.62
± 6.84
Control - EMPOWER Clinic
-2.52
± 4.66
Mean Change From Baseline to 6 Months in Glycosylated HemoglobinPrimary· Baseline to 6 Months
a blood test that measures the average blood glucose over three months
Group
Value
95% CI
Experimental - Telehealth
-0.27
± .85
Control - EMPOWER Clinic
-.16
± 0.24
Mean Change From Baseline to 6 Months in Alanine AminotransferasePrimary· 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.
Group
Value
95% CI
Experimental - Telehealth
18.8
± 156.00
Control - EMPOWER Clinic
3.00
± 24.6
Mean Change in Triglycerides From Baseline to 6 MonthsPrimary· Baseline to 6 Months
Triglycerides will be assessed via blood tests and measured in milligrams per deciliter (mg/dL).
Group
Value
95% CI
Experimental - Telehealth
-7.2
± 70.31
Control - EMPOWER Clinic
-44.71
± 124.13
Mean Change in Diastolic Blood Pressure From Baseline to 6 MonthsPrimary· 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.
Group
Value
95% CI
Experimental - Telehealth
-2.47
± 6.8
Control - EMPOWER Clinic
-2.88
± 9.81
Mean Change in Systolic Blood Pressure From Baseline to 6 MonthsPrimary· 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.
Group
Value
95% CI
Experimental - Telehealth
4.1
± 10.1
Control - EMPOWER Clinic
-4.82
± 9.74
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1Secondary· 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?
Group
Value
95% CI
Experimental - Telehealth
0.7
± 0.7
accepted just as you are?
Group
Value
95% CI
Experimental - Telehealth
0
± 1
challenged and encouraged through sports?
Group
Value
95% CI
Experimental - Telehealth
0.4
± 1.3
successful or skilled in some sport or other activity you like?
Group
Value
95% CI
Experimental - Telehealth
0.7
± 0.6
happy with yourself?
Group
Value
95% CI
Experimental - Telehealth
0
± 0.7
able to speak up for yourself?
Group
Value
95% CI
Experimental - Telehealth
0.9
± 1.1
satisfied with your school day?
Group
Value
95% CI
Experimental - Telehealth
0.1
± 1.1
able to take part in group activities?
Group
Value
95% CI
Experimental - Telehealth
1.0
± 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.
Group
Value
95% CI
Control - EMPOWER Clinic
0.06
± 0.42
I got tired and out of breath quickly compared to others when being physically active.
Group
Value
95% CI
Control - EMPOWER Clinic
-0.12
± 0.76
During the past week I was sad and depressed because of my weight
Group
Value
95% CI
Control - EMPOWER Clinic
-0.12
± 0.90
During the past week I was annoyed by my many attempts at losing weight
Group
Value
95% CI
Control - EMPOWER Clinic
-0.88
± 1.08
During the past week I felt ashamed because of my weight
Group
Value
95% CI
Control - EMPOWER Clinic
-.35
± 0.97
During the past week was dissatisfied with myself because of my weight
Group
Value
95% CI
Control - EMPOWER Clinic
-0.59
± 1.19
During the past week my family scolded me because of my weight
Group
Value
95% CI
Control - EMPOWER Clinic
-0.47
± 1.72
During the past week had to eat at home because I'm watching my weight
Group
Value
95% CI
Control - EMPOWER Clinic
0.12
± 1.32
Satisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireSecondary· 6 Months
Satisfaction measurements will be obtained through "Satisfaction using Telehealth" questionnaire.
I felt comfortable using technology for my online sessions.
Group
Value
95% CI
Experimental - Telehealth
13
Experimental - Telehealth
4
Experimental - Telehealth
0
Participating in the TH sessions was much easier than going in person doctor's appointment.
Group
Value
95% CI
Experimental - Telehealth
10
Experimental - Telehealth
7
Experimental - Telehealth
0
I would like to have online sessions again.
Group
Value
95% CI
Experimental - Telehealth
8
Experimental - Telehealth
9
Experimental - Telehealth
0
I liked talking to other teens and young adults during the online sessions.
Group
Value
95% CI
Experimental - Telehealth
5
Experimental - Telehealth
12
Experimental - Telehealth
0
I felt supported during the group sessions.
Group
Value
95% CI
Experimental - Telehealth
14
Experimental - Telehealth
3
Experimental - Telehealth
0
I felt comfortable asking the session leader questions throughout the online sessions.
Group
Value
95% CI
Experimental - Telehealth
12
Experimental - Telehealth
5
Experimental - Telehealth
0
I was able to speak freely and express myself.
Group
Value
95% CI
Experimental - Telehealth
14
Experimental - Telehealth
3
Experimental - Telehealth
0
I felt comfortable showing my face with others on screen during the sessions.
Group
Value
95% CI
Experimental - Telehealth
3
Experimental - Telehealth
9
Experimental - Telehealth
5
Attendance/Retention From Baseline to 6 MonthsSecondary· Baseline to 6 Months
Attendance, no-show and same-day reschedules
Group
Value
95% CI
Experimental - Telehealth
6.9
1 – 12
Control - EMPOWER Clinic
5.5
5 – 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.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Los Angeles
Last refreshed: 9 September 2025
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.