Trial Outcomes & Findings for Group Telehealth Weight Management Visits for Adolescents With Obesity (NCT NCT03508622)
NCT ID: NCT03508622
Last Updated: 2025-09-09
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Baseline to 6 Months
Results posted on
2025-09-09
Participant Flow
Participant milestones
| Measure |
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.
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.
|
Control - EMPOWER Clinic
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
15
|
9
|
|
Overall Study
NOT COMPLETED
|
18
|
24
|
Reasons for withdrawal
| Measure |
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.
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.
|
Control - EMPOWER Clinic
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.
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
16
|
0
|
|
Overall Study
Incomplete data
|
0
|
24
|
Baseline Characteristics
Group Telehealth Weight Management Visits for Adolescents With Obesity
Baseline characteristics by cohort
| Measure |
Experimental - Telehealth
n=31 Participants
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.
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.
|
Control - EMPOWER Clinic
n=33 Participants
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.
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.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16.27 years
STANDARD_DEVIATION 1.52 • n=5 Participants
|
15.51 years
STANDARD_DEVIATION 3.84 • n=7 Participants
|
15.88 years
STANDARD_DEVIATION 2.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic/Latino
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Non-Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Mexican
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black/African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic/Latino
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White/Caucasian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Mexican
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 MonthsA measure for body adiposity calculated by dividing a participant's weight in kilograms by the square of their height in meters (kg/m\^2)
Outcome measures
| Measure |
Experimental - Telehealth
n=31 Participants
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.
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.
|
Control - EMPOWER Clinic
n=33 Participants
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.
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.
|
|---|---|---|
|
Mean Change From Baseline to 6 Months in Body Mass Index
|
1.07 kilograms by the square of their height
Standard Deviation 2.06
|
0.17 kilograms by the square of their height
Standard Deviation 1.43
|
PRIMARY outcome
Timeframe: Baseline to 6 MonthsA 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
Outcome measures
| Measure |
Experimental - Telehealth
n=31 Participants
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.
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.
|
Control - EMPOWER Clinic
n=33 Participants
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.
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.
|
|---|---|---|
|
Mean Change From Baseline to 6 Months in Percentage of 95th Percentile Body Mass Index
|
1.62 percent 95th percentile body mass index
Standard Deviation 6.84
|
-2.52 percent 95th percentile body mass index
Standard Deviation 4.66
|
PRIMARY outcome
Timeframe: Baseline to 6 Monthsa blood test that measures the average blood glucose over three months
Outcome measures
| Measure |
Experimental - Telehealth
n=31 Participants
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.
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.
|
Control - EMPOWER Clinic
n=33 Participants
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.
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.
|
|---|---|---|
|
Mean Change From Baseline to 6 Months in Glycosylated Hemoglobin
|
-0.27 mg/dL
Standard Deviation .85
|
-.16 mg/dL
Standard Deviation 0.24
|
PRIMARY outcome
Timeframe: Baseline to 6 MonthsAlanine 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.
Outcome measures
| Measure |
Experimental - Telehealth
n=15 Participants
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.
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.
|
Control - EMPOWER Clinic
n=9 Participants
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.
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.
|
|---|---|---|
|
Mean Change From Baseline to 6 Months in Alanine Aminotransferase
|
18.8 units per liter (U/L)
Standard Deviation 156.00
|
3.00 units per liter (U/L)
Standard Deviation 24.6
|
PRIMARY outcome
Timeframe: Baseline to 6 MonthsTriglycerides will be assessed via blood tests and measured in milligrams per deciliter (mg/dL).
Outcome measures
| Measure |
Experimental - Telehealth
n=31 Participants
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.
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.
|
Control - EMPOWER Clinic
n=33 Participants
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.
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.
|
|---|---|---|
|
Mean Change in Triglycerides From Baseline to 6 Months
|
-7.2 milligrams per deciliter (mg/dL)
Standard Deviation 70.31
|
-44.71 milligrams per deciliter (mg/dL)
Standard Deviation 124.13
|
PRIMARY outcome
Timeframe: Baseline to 6 MonthsBlood 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.
Outcome measures
| Measure |
Experimental - Telehealth
n=15 Participants
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.
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.
|
Control - EMPOWER Clinic
n=33 Participants
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.
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.
|
|---|---|---|
|
Mean Change in Diastolic Blood Pressure From Baseline to 6 Months
|
-2.47 millimeters of mercury (mmHg)
Standard Deviation 6.8
|
-2.88 millimeters of mercury (mmHg)
Standard Deviation 9.81
|
PRIMARY outcome
Timeframe: Baseline to 6 MonthsBlood 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.
Outcome measures
| Measure |
Experimental - Telehealth
n=15 Participants
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.
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.
|
Control - EMPOWER Clinic
n=33 Participants
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.
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.
|
|---|---|---|
|
Mean Change in Systolic Blood Pressure From Baseline to 6 Months
|
4.1 millimeters of mercury (mmHg)
Standard Deviation 10.1
|
-4.82 millimeters of mercury (mmHg)
Standard Deviation 9.74
|
SECONDARY outcome
Timeframe: Baseline to 6 MonthsQuality 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.
Outcome measures
| Measure |
Experimental - Telehealth
n=17 Participants
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.
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.
|
Control - EMPOWER Clinic
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.
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.
|
|---|---|---|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that : you are able to go out on dates and to parties?
|
0.5 score on a scale
Standard Deviation 1.1
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that : you will be able to hold down a part-time job?
|
0.5 score on a scale
Standard Deviation 1.0
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that : you will be able to have children in the future?
|
0.4 score on a scale
Standard Deviation 1.4
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that : you will marry?
|
-0.2 score on a scale
Standard Deviation 1.2
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that : you have a close friend who is like you in many ways?
|
0.1 score on a scale
Standard Deviation 1.3
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
are as independent as you are able to be?
|
0.1 score on a scale
Standard Deviation 0.9
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
have the physical strength to do sports like swimming, soccer, basketball, etc?
|
0.5 score on a scale
Standard Deviation 0.9
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that you: have a lot of pain?
|
-0.4 score on a scale
Standard Deviation 0.9
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that you: are positive about yourself?
|
0.1 score on a scale
Standard Deviation 0.7
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that you: can speak up for yourself?
|
0.2 score on a scale
Standard Deviation 1.4
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that you can make your own choices and decisions?
|
-.05 score on a scale
Standard Deviation 0.8
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that you: are treated the same as the other kids?
|
0.2 score on a scale
Standard Deviation 0.8
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
treated the same as everyone else?
|
0.7 score on a scale
Standard Deviation 0.7
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
accepted just as you are?
|
0 score on a scale
Standard Deviation 1
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
challenged and encouraged through sports?
|
0.4 score on a scale
Standard Deviation 1.3
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
successful or skilled in some sport or other activity you like?
|
0.7 score on a scale
Standard Deviation 0.6
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
happy with yourself?
|
0 score on a scale
Standard Deviation 0.7
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
able to speak up for yourself?
|
0.9 score on a scale
Standard Deviation 1.1
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
satisfied with your school day?
|
0.1 score on a scale
Standard Deviation 1.1
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
able to take part in group activities?
|
1.0 score on a scale
Standard Deviation 1.6
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
able to have a special friend?
|
0.4 score on a scale
Standard Deviation 1.4
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that: other people respect you? (not teased; include you in activities)
|
0.05 score on a scale
Standard Deviation 0.8
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
you have a say in your medical treatment?
|
0.2 score on a scale
Standard Deviation 1.35
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that: you understand the long term health impacts of being overweight?
|
-0.1 score on a scale
Standard Deviation 0.7
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that: people see you for who you are?
|
0.2 score on a scale
Standard Deviation 0.8
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that: you are able use the kitchen at home?
|
-0.05 score on a scale
Standard Deviation 0.8
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that: you participate in outdoor activities?
|
0.5 score on a scale
Standard Deviation 1.1
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that : there is hope for the future?
|
0 score on a scale
Standard Deviation 0.5
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that : you will have a suitable home in the future?
|
0 score on a scale
Standard Deviation 0.5
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that : there will be job opportunities for you in the future?
|
0.2 score on a scale
Standard Deviation 1.0
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that : you are able to get an education for a job that interests you?
|
0.1 score on a scale
Standard Deviation 1.1
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
How much do you feel that : you have a career goal in mind?
|
0.1 score on a scale
Standard Deviation 0.8
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 MonthsQuality 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
Outcome measures
| Measure |
Experimental - Telehealth
n=31 Participants
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.
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.
|
Control - EMPOWER Clinic
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.
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.
|
|---|---|---|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
During the past week I felt so big that it was hard to move.
|
0.06 units on a scale
Standard Deviation 0.42
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
I got tired and out of breath quickly compared to others when being physically active.
|
-0.12 units on a scale
Standard Deviation 0.76
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
During the past week I was sad and depressed because of my weight
|
-0.12 units on a scale
Standard Deviation 0.90
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
During the past week I was annoyed by my many attempts at losing weight
|
-0.88 units on a scale
Standard Deviation 1.08
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
During the past week I felt ashamed because of my weight
|
-.35 units on a scale
Standard Deviation 0.97
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
During the past week was dissatisfied with myself because of my weight
|
-0.59 units on a scale
Standard Deviation 1.19
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
During the past week my family scolded me because of my weight
|
-0.47 units on a scale
Standard Deviation 1.72
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
During the past week had to eat at home because I'm watching my weight
|
0.12 units on a scale
Standard Deviation 1.32
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
During the past week was teased by others because of my weight
|
0.12 units on a scale
Standard Deviation 1.32
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
During the past week was left out by others when they did things together, because of my weight
|
0.06 units on a scale
Standard Deviation 1.06
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
During the past week was distracted during school by the thought of food
|
-0.35 units on a scale
Standard Deviation 1.23
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
During the past week I was not able to take part in sports at school because of my weight
|
-0.29 units on a scale
Standard Deviation 1.18
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
How often during the past week did you feel physically uncomfortable because of being obese?
|
0.12 units on a scale
Standard Deviation 0.96
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
How severe was your discomfort because of being overweight during the past week?
|
-0.35 units on a scale
Standard Deviation 0.97
|
—
|
|
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
How much did it bother you being overweight during the past week?
|
-0.29 units on a scale
Standard Deviation 0.96
|
—
|
SECONDARY outcome
Timeframe: 6 MonthsSatisfaction measurements will be obtained through "Satisfaction using Telehealth" questionnaire.
Outcome measures
| Measure |
Experimental - Telehealth
n=17 Participants
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.
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.
|
Control - EMPOWER Clinic
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.
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.
|
|---|---|---|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I liked talking to other teens and young adults during the online sessions. · Neutral
|
12 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I liked talking to other teens and young adults during the online sessions. · Disagree or Strongly Disagree
|
0 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt comfortable showing my face with others on screen during the sessions. · Neutral
|
9 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt comfortable showing my face with others on screen during the sessions. · Disagree or Strongly Disagree
|
5 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I liked the group style of the sessions. · Agree or Strongly Agree
|
10 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I liked the group style of the sessions. · Disagree or Strongly Disagree
|
0 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I enjoyed watching the videos that were shown and discussed during the online sessions. · Agree or Strongly Agree
|
13 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I enjoyed watching the videos that were shown and discussed during the online sessions. · Neutral
|
4 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I am satisfied with the health care and medical information that I received for weight management · Agree or Strongly Agree
|
15 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt comfortable using technology for my online sessions. · Agree or Strongly Agree
|
13 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt comfortable using technology for my online sessions. · Neutral
|
4 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt comfortable using technology for my online sessions. · Disagree or Strongly Disagree
|
0 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
Participating in the TH sessions was much easier than going in person doctor's appointment. · Agree or Strongly Agree
|
10 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
Participating in the TH sessions was much easier than going in person doctor's appointment. · Neutral
|
7 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
Participating in the TH sessions was much easier than going in person doctor's appointment. · Disagree or Strongly Disagree
|
0 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I would like to have online sessions again. · Agree or Strongly Agree
|
8 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I would like to have online sessions again. · Neutral
|
9 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I would like to have online sessions again. · Disagree or Strongly Disagree
|
0 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I liked talking to other teens and young adults during the online sessions. · Agree or Strongly Agree
|
5 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt supported during the group sessions. · Agree or Strongly Agree
|
14 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt supported during the group sessions. · Neutral
|
3 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt supported during the group sessions. · Disagree or Strongly Disagree
|
0 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt comfortable asking the session leader questions throughout the online sessions. · Agree or Strongly Agree
|
12 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt comfortable asking the session leader questions throughout the online sessions. · Neutral
|
5 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt comfortable asking the session leader questions throughout the online sessions. · Disagree or Strongly Disagree
|
0 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I was able to speak freely and express myself. · Agree or Strongly Agree
|
14 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I was able to speak freely and express myself. · Neutral
|
3 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I was able to speak freely and express myself. · Disagree or Strongly Disagree
|
0 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt comfortable showing my face with others on screen during the sessions. · Agree or Strongly Agree
|
3 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I liked the group style of the sessions. · Neutral
|
7 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt that the check-ins between sessions helped me stay motivated to work on my goals/activities. · Agree or Strongly Agree
|
9 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt that the check-ins between sessions helped me stay motivated to work on my goals/activities. · Neutral
|
6 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt that the check-ins between sessions helped me stay motivated to work on my goals/activities. · Disagree or Strongly Disagree
|
2 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt that the check-ins helped me to follow through with my goals and photovoice activities. · Agree or Strongly Agree
|
12 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt that the check-ins helped me to follow through with my goals and photovoice activities. · Neutral
|
5 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I felt that the check-ins helped me to follow through with my goals and photovoice activities. · Disagree or Strongly Disagree
|
0 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I would recommend telehealth as a form of receiving personalized health care and medical information · Agree or Strongly Agree
|
12 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I would recommend telehealth as a form of receiving personalized health care and medical information · Neutral
|
5 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I would recommend telehealth as a form of receiving personalized health care and medical information · Disagree or Strongly Disagree
|
0 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I enjoyed watching the videos that were shown and discussed during the online sessions. · Disagree or Strongly Disagree
|
0 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I am satisfied with the health care and medical information that I received for weight management · Neutral
|
2 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
I am satisfied with the health care and medical information that I received for weight management · Disagree or Strongly Disagree
|
0 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
The session leader provided education that was easy to understand · Agree or Strongly Agree
|
15 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
The session leader provided education that was easy to understand · Neutral
|
2 Participants
|
—
|
|
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
The session leader provided education that was easy to understand · Disagree or Strongly Disagree
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 MonthsAttendance, no-show and same-day reschedules
Outcome measures
| Measure |
Experimental - Telehealth
n=16 Participants
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.
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.
|
Control - EMPOWER Clinic
n=33 Participants
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.
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.
|
|---|---|---|
|
Attendance/Retention From Baseline to 6 Months
|
6.9 patient visits
Interval 1.0 to 12.0
|
5.5 patient visits
Interval 5.0 to 7.0
|
Adverse Events
Telehealth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Empower
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place