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Group Telehealth Weight Management Visits for Adolescents With Obesity

Group Telehealth Weight Management Visits for Adolescents With Obesity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03508622
Enrollment
66
Registered
2018-04-26
Start date
2018-01-01
Completion date
2021-05-01
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

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: 1. Pilot a new care delivery model for CHLA EMPOWER patients using group telehealth visits. 2. Assess the feasibility of using telehealth with adolescent patients 3. Test the efficacy of group health education sessions using video conference technology Hypotheses: 1. Use of group health education sessions using video conference technology is a feasible, cost-effective care delivery model for adolescents being treated for obesity. 2. 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 3. 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.

Interventions

BEHAVIORALTelehealth 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.

BEHAVIORALEmpower 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.

Sponsors

National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
Children's Hospital Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Pilot intervention using retrospective control group.

Eligibility

Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean Change in Systolic Blood Pressure From Baseline to 6 MonthsBaseline 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.
Mean Change From Baseline to 6 Months in Glycosylated HemoglobinBaseline to 6 Monthsa blood test that measures the average blood glucose over three months
Mean Change From Baseline to 6 Months in Alanine AminotransferaseBaseline 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.
Mean Change in Triglycerides From Baseline to 6 MonthsBaseline to 6 MonthsTriglycerides will be assessed via blood tests and measured in milligrams per deciliter (mg/dL).
Mean Change in Diastolic Blood Pressure From Baseline to 6 MonthsBaseline 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.
Mean Change From Baseline to 6 Months in Body Mass IndexBaseline 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)
Mean Change From Baseline to 6 Months in Percentage of 95th Percentile Body Mass IndexBaseline 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

Secondary

MeasureTime frameDescription
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.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
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire6 MonthsSatisfaction measurements will be obtained through Satisfaction using Telehealth questionnaire.
Attendance/Retention From Baseline to 6 MonthsBaseline to 6 MonthsAttendance, no-show and same-day reschedules
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1Baseline 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
31
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.
33
Total64

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyIncomplete data024
Overall StudyLost to Follow-up160
Overall StudyProtocol Violation10
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicExperimental - TelehealthControl - EMPOWER ClinicTotal
Age, Categorical
<=18 years
5 Participants3 Participants8 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
26 Participants30 Participants56 Participants
Age, Continuous16.27 years
STANDARD_DEVIATION 1.52
15.51 years
STANDARD_DEVIATION 3.84
15.88 years
STANDARD_DEVIATION 2.96
Race/Ethnicity, Customized
Ethnicity
American Indian or Alaskan Native
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Ethnicity
Asian or Pacific Islander
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Ethnicity
Black/African American
3 Participants0 Participants3 Participants
Race/Ethnicity, Customized
Ethnicity
Hispanic/Latino
26 Participants20 Participants46 Participants
Race/Ethnicity, Customized
Ethnicity
Mexican
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Ethnicity
Non-Hispanic
0 Participants6 Participants6 Participants
Race/Ethnicity, Customized
Ethnicity
Other
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Ethnicity
Unknown
0 Participants6 Participants6 Participants
Race/Ethnicity, Customized
Ethnicity
White/Caucasian
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race
American Indian or Alaskan Native
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Race
Asian or Pacific Islander
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race
Black/African American
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race
Hispanic/Latino
13 Participants3 Participants16 Participants
Race/Ethnicity, Customized
Race
Mexican
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race
Non-Hispanic
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Race
Other
4 Participants15 Participants19 Participants
Race/Ethnicity, Customized
Race
Unknown
9 Participants6 Participants15 Participants
Race/Ethnicity, Customized
Race
White/Caucasian
2 Participants9 Participants11 Participants
Sex: Female, Male
Female
19 Participants18 Participants37 Participants
Sex: Female, Male
Male
12 Participants15 Participants27 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 33
other
Total, other adverse events
0 / 310 / 33
serious
Total, serious adverse events
0 / 310 / 33

Outcome results

Primary

Mean Change From Baseline to 6 Months in Alanine Aminotransferase

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.

Time frame: Baseline to 6 Months

ArmMeasureValue (MEAN)Dispersion
Experimental - TelehealthMean Change From Baseline to 6 Months in Alanine Aminotransferase18.8 units per liter (U/L)Standard Deviation 156
Control - EMPOWER ClinicMean Change From Baseline to 6 Months in Alanine Aminotransferase3.00 units per liter (U/L)Standard Deviation 24.6
Primary

Mean Change From Baseline to 6 Months in Body Mass Index

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)

Time frame: Baseline to 6 Months

ArmMeasureValue (MEAN)Dispersion
Experimental - TelehealthMean Change From Baseline to 6 Months in Body Mass Index1.07 kilograms by the square of their heightStandard Deviation 2.06
Control - EMPOWER ClinicMean Change From Baseline to 6 Months in Body Mass Index0.17 kilograms by the square of their heightStandard Deviation 1.43
Primary

Mean Change From Baseline to 6 Months in Glycosylated Hemoglobin

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

Time frame: Baseline to 6 Months

ArmMeasureValue (MEAN)Dispersion
Experimental - TelehealthMean Change From Baseline to 6 Months in Glycosylated Hemoglobin-0.27 mg/dLStandard Deviation 0.85
Control - EMPOWER ClinicMean Change From Baseline to 6 Months in Glycosylated Hemoglobin-.16 mg/dLStandard Deviation 0.24
Primary

Mean Change From Baseline to 6 Months in Percentage of 95th Percentile Body Mass Index

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

Time frame: Baseline to 6 Months

ArmMeasureValue (MEAN)Dispersion
Experimental - TelehealthMean Change From Baseline to 6 Months in Percentage of 95th Percentile Body Mass Index1.62 percent 95th percentile body mass indexStandard Deviation 6.84
Control - EMPOWER ClinicMean Change From Baseline to 6 Months in Percentage of 95th Percentile Body Mass Index-2.52 percent 95th percentile body mass indexStandard Deviation 4.66
Primary

Mean Change in Diastolic Blood Pressure From 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.

Time frame: Baseline to 6 Months

ArmMeasureValue (MEAN)Dispersion
Experimental - TelehealthMean Change in Diastolic Blood Pressure From Baseline to 6 Months-2.47 millimeters of mercury (mmHg)Standard Deviation 6.8
Control - EMPOWER ClinicMean Change in Diastolic Blood Pressure From Baseline to 6 Months-2.88 millimeters of mercury (mmHg)Standard Deviation 9.81
Primary

Mean Change in Systolic Blood Pressure From 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.

Time frame: Baseline to 6 Months

ArmMeasureValue (MEAN)Dispersion
Experimental - TelehealthMean Change in Systolic Blood Pressure From Baseline to 6 Months4.1 millimeters of mercury (mmHg)Standard Deviation 10.1
Control - EMPOWER ClinicMean Change in Systolic Blood Pressure From Baseline to 6 Months-4.82 millimeters of mercury (mmHg)Standard Deviation 9.74
Primary

Mean Change in Triglycerides From Baseline to 6 Months

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

Time frame: Baseline to 6 Months

ArmMeasureValue (MEAN)Dispersion
Experimental - TelehealthMean Change in Triglycerides From Baseline to 6 Months-7.2 milligrams per deciliter (mg/dL)Standard Deviation 70.31
Control - EMPOWER ClinicMean Change in Triglycerides From Baseline to 6 Months-44.71 milligrams per deciliter (mg/dL)Standard Deviation 124.13
Secondary

Attendance/Retention From Baseline to 6 Months

Attendance, no-show and same-day reschedules

Time frame: Baseline to 6 Months

ArmMeasureValue (MEAN)
Experimental - TelehealthAttendance/Retention From Baseline to 6 Months6.9 patient visits
Control - EMPOWER ClinicAttendance/Retention From Baseline to 6 Months5.5 patient visits
Secondary

Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1

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.

Time frame: Baseline to 6 Months

ArmMeasureGroupValue (MEAN)Dispersion
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that : there will be job opportunities for you in the future?0.2 score on a scaleStandard Deviation 1
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1treated the same as everyone else?0.7 score on a scaleStandard Deviation 0.7
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1accepted just as you are?0 score on a scaleStandard Deviation 1
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1challenged and encouraged through sports?0.4 score on a scaleStandard Deviation 1.3
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1successful or skilled in some sport or other activity you like?0.7 score on a scaleStandard Deviation 0.6
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1happy with yourself?0 score on a scaleStandard Deviation 0.7
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1able to speak up for yourself?0.9 score on a scaleStandard Deviation 1.1
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1satisfied with your school day?0.1 score on a scaleStandard Deviation 1.1
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1able to take part in group activities?1.0 score on a scaleStandard Deviation 1.6
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1able to have a special friend?0.4 score on a scaleStandard Deviation 1.4
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1are as independent as you are able to be?0.1 score on a scaleStandard Deviation 0.9
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1have the physical strength to do sports like swimming, soccer, basketball, etc?0.5 score on a scaleStandard Deviation 0.9
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that you: have a lot of pain?-0.4 score on a scaleStandard Deviation 0.9
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that you: can speak up for yourself?0.2 score on a scaleStandard Deviation 1.4
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that you can make your own choices and decisions?-.05 score on a scaleStandard Deviation 0.8
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that you: are treated the same as the other kids?0.2 score on a scaleStandard Deviation 0.8
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that you: are positive about yourself?0.1 score on a scaleStandard Deviation 0.7
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that: other people respect you? (not teased; include you in activities)0.05 score on a scaleStandard Deviation 0.8
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1you have a say in your medical treatment?0.2 score on a scaleStandard Deviation 1.35
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that: you understand the long term health impacts of being overweight?-0.1 score on a scaleStandard Deviation 0.7
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that: people see you for who you are?0.2 score on a scaleStandard Deviation 0.8
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that: you are able use the kitchen at home?-0.05 score on a scaleStandard Deviation 0.8
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that: you participate in outdoor activities?0.5 score on a scaleStandard Deviation 1.1
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that : there is hope for the future?0 score on a scaleStandard Deviation 0.5
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that : you will have a suitable home in the future?0 score on a scaleStandard Deviation 0.5
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that : you are able to go out on dates and to parties?0.5 score on a scaleStandard Deviation 1.1
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that : you are able to get an education for a job that interests you?0.1 score on a scaleStandard Deviation 1.1
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that : you have a career goal in mind?0.1 score on a scaleStandard Deviation 0.8
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that : you will be able to hold down a part-time job?0.5 score on a scaleStandard Deviation 1
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that : you will be able to have children in the future?0.4 score on a scaleStandard Deviation 1.4
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that : you will marry?-0.2 score on a scaleStandard Deviation 1.2
Experimental - TelehealthChange in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1How much do you feel that : you have a close friend who is like you in many ways?0.1 score on a scaleStandard Deviation 1.3
Secondary

Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.

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

Time frame: Baseline to 6 Months

ArmMeasureGroupValue (MEAN)Dispersion
Experimental - TelehealthChange 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 weight0.12 units on a scaleStandard Deviation 1.32
Experimental - TelehealthChange 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 scaleStandard Deviation 0.42
Experimental - TelehealthChange 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 scaleStandard Deviation 0.76
Experimental - TelehealthChange 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 scaleStandard Deviation 0.9
Experimental - TelehealthChange 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 scaleStandard Deviation 1.08
Experimental - TelehealthChange 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 scaleStandard Deviation 0.97
Experimental - TelehealthChange 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 scaleStandard Deviation 1.19
Experimental - TelehealthChange 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 scaleStandard Deviation 1.72
Experimental - TelehealthChange 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 weight0.12 units on a scaleStandard Deviation 1.32
Experimental - TelehealthChange 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 weight0.06 units on a scaleStandard Deviation 1.06
Experimental - TelehealthChange 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 scaleStandard Deviation 1.23
Experimental - TelehealthChange 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 scaleStandard Deviation 1.18
Experimental - TelehealthChange 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 scaleStandard Deviation 0.96
Experimental - TelehealthChange 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 scaleStandard Deviation 0.97
Experimental - TelehealthChange 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 scaleStandard Deviation 0.96
Secondary

Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire

Satisfaction measurements will be obtained through Satisfaction using Telehealth questionnaire.

Time frame: 6 Months

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt comfortable using technology for my online sessions.Agree or Strongly Agree13 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt comfortable using technology for my online sessions.Neutral4 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt comfortable using technology for my online sessions.Disagree or Strongly Disagree0 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireParticipating in the TH sessions was much easier than going in person doctor's appointment.Agree or Strongly Agree10 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireParticipating in the TH sessions was much easier than going in person doctor's appointment.Neutral7 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireParticipating in the TH sessions was much easier than going in person doctor's appointment.Disagree or Strongly Disagree0 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI would like to have online sessions again.Agree or Strongly Agree8 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI would like to have online sessions again.Neutral9 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI would like to have online sessions again.Disagree or Strongly Disagree0 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI liked talking to other teens and young adults during the online sessions.Agree or Strongly Agree5 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI liked talking to other teens and young adults during the online sessions.Neutral12 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI liked talking to other teens and young adults during the online sessions.Disagree or Strongly Disagree0 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt supported during the group sessions.Agree or Strongly Agree14 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt supported during the group sessions.Neutral3 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt supported during the group sessions.Disagree or Strongly Disagree0 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt comfortable asking the session leader questions throughout the online sessions.Agree or Strongly Agree12 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt comfortable asking the session leader questions throughout the online sessions.Neutral5 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt comfortable asking the session leader questions throughout the online sessions.Disagree or Strongly Disagree0 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI was able to speak freely and express myself.Agree or Strongly Agree14 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI was able to speak freely and express myself.Neutral3 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI was able to speak freely and express myself.Disagree or Strongly Disagree0 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt comfortable showing my face with others on screen during the sessions.Agree or Strongly Agree3 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt comfortable showing my face with others on screen during the sessions.Neutral9 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt comfortable showing my face with others on screen during the sessions.Disagree or Strongly Disagree5 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI liked the group style of the sessions.Agree or Strongly Agree10 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI liked the group style of the sessions.Neutral7 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI liked the group style of the sessions.Disagree or Strongly Disagree0 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt that the check-ins between sessions helped me stay motivated to work on my goals/activities.Agree or Strongly Agree9 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt that the check-ins between sessions helped me stay motivated to work on my goals/activities.Neutral6 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt that the check-ins between sessions helped me stay motivated to work on my goals/activities.Disagree or Strongly Disagree2 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt that the check-ins helped me to follow through with my goals and photovoice activities.Agree or Strongly Agree12 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt that the check-ins helped me to follow through with my goals and photovoice activities.Neutral5 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI felt that the check-ins helped me to follow through with my goals and photovoice activities.Disagree or Strongly Disagree0 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI would recommend telehealth as a form of receiving personalized health care and medical informationAgree or Strongly Agree12 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI would recommend telehealth as a form of receiving personalized health care and medical informationNeutral5 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI would recommend telehealth as a form of receiving personalized health care and medical informationDisagree or Strongly Disagree0 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI enjoyed watching the videos that were shown and discussed during the online sessions.Agree or Strongly Agree13 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI enjoyed watching the videos that were shown and discussed during the online sessions.Neutral4 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI enjoyed watching the videos that were shown and discussed during the online sessions.Disagree or Strongly Disagree0 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI am satisfied with the health care and medical information that I received for weight managementAgree or Strongly Agree15 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI am satisfied with the health care and medical information that I received for weight managementNeutral2 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireI am satisfied with the health care and medical information that I received for weight managementDisagree or Strongly Disagree0 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireThe session leader provided education that was easy to understandAgree or Strongly Agree15 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireThe session leader provided education that was easy to understandNeutral2 Participants
Experimental - TelehealthSatisfaction With Care at 6 Months Using Satisfaction Telehealth QuestionnaireThe session leader provided education that was easy to understandDisagree or Strongly Disagree0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026