Obesity, Childhood
Conditions
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
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.
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
Study design
Intervention model description
Pilot intervention using retrospective control group.
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Systolic Blood Pressure From Baseline to 6 Months | 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. |
| Mean Change From Baseline to 6 Months in Glycosylated Hemoglobin | Baseline to 6 Months | a blood test that measures the average blood glucose over three months |
| Mean Change From Baseline to 6 Months in Alanine Aminotransferase | 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. |
| Mean Change in Triglycerides From Baseline to 6 Months | Baseline to 6 Months | Triglycerides will be assessed via blood tests and measured in milligrams per deciliter (mg/dL). |
| Mean Change in Diastolic Blood Pressure From Baseline to 6 Months | 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. |
| Mean Change From Baseline to 6 Months in Body Mass Index | 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) |
| Mean Change From Baseline to 6 Months in Percentage of 95th Percentile Body Mass Index | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire. | 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 |
| Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | 6 Months | Satisfaction measurements will be obtained through Satisfaction using Telehealth questionnaire. |
| Attendance/Retention From Baseline to 6 Months | Baseline to 6 Months | Attendance, no-show and same-day reschedules |
| Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete data | 0 | 24 |
| Overall Study | Lost to Follow-up | 16 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Experimental - Telehealth | Control - EMPOWER Clinic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 30 Participants | 56 Participants |
| Age, Continuous | 16.27 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 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Asian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Black/African American | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic/Latino | 26 Participants | 20 Participants | 46 Participants |
| Race/Ethnicity, Customized Ethnicity Mexican | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Hispanic | 0 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown | 0 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized Ethnicity White/Caucasian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaskan Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian or Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black/African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Hispanic/Latino | 13 Participants | 3 Participants | 16 Participants |
| Race/Ethnicity, Customized Race Mexican | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Non-Hispanic | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 4 Participants | 15 Participants | 19 Participants |
| Race/Ethnicity, Customized Race Unknown | 9 Participants | 6 Participants | 15 Participants |
| Race/Ethnicity, Customized Race White/Caucasian | 2 Participants | 9 Participants | 11 Participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 37 Participants |
| Sex: Female, Male Male | 12 Participants | 15 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 33 |
| other Total, other adverse events | 0 / 31 | 0 / 33 |
| serious Total, serious adverse events | 0 / 31 | 0 / 33 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental - Telehealth | Mean Change From Baseline to 6 Months in Alanine Aminotransferase | 18.8 units per liter (U/L) | Standard Deviation 156 |
| Control - EMPOWER Clinic | Mean Change From Baseline to 6 Months in Alanine Aminotransferase | 3.00 units per liter (U/L) | Standard Deviation 24.6 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental - Telehealth | Mean Change From Baseline to 6 Months in Body Mass Index | 1.07 kilograms by the square of their height | Standard Deviation 2.06 |
| Control - EMPOWER Clinic | Mean Change From Baseline to 6 Months in Body Mass Index | 0.17 kilograms by the square of their height | Standard Deviation 1.43 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental - Telehealth | Mean Change From Baseline to 6 Months in Glycosylated Hemoglobin | -0.27 mg/dL | Standard Deviation 0.85 |
| Control - EMPOWER Clinic | Mean Change From Baseline to 6 Months in Glycosylated Hemoglobin | -.16 mg/dL | Standard Deviation 0.24 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental - Telehealth | 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 |
| Control - EMPOWER Clinic | Mean Change From Baseline to 6 Months in Percentage of 95th Percentile Body Mass Index | -2.52 percent 95th percentile body mass index | Standard Deviation 4.66 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental - Telehealth | Mean Change in Diastolic Blood Pressure From Baseline to 6 Months | -2.47 millimeters of mercury (mmHg) | Standard Deviation 6.8 |
| Control - EMPOWER Clinic | Mean Change in Diastolic Blood Pressure From Baseline to 6 Months | -2.88 millimeters of mercury (mmHg) | Standard Deviation 9.81 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental - Telehealth | Mean Change in Systolic Blood Pressure From Baseline to 6 Months | 4.1 millimeters of mercury (mmHg) | Standard Deviation 10.1 |
| Control - EMPOWER Clinic | Mean Change in Systolic Blood Pressure From Baseline to 6 Months | -4.82 millimeters of mercury (mmHg) | Standard Deviation 9.74 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental - Telehealth | Mean Change in Triglycerides From Baseline to 6 Months | -7.2 milligrams per deciliter (mg/dL) | Standard Deviation 70.31 |
| Control - EMPOWER Clinic | Mean Change in Triglycerides From Baseline to 6 Months | -44.71 milligrams per deciliter (mg/dL) | Standard Deviation 124.13 |
Attendance/Retention From Baseline to 6 Months
Attendance, no-show and same-day reschedules
Time frame: Baseline to 6 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental - Telehealth | Attendance/Retention From Baseline to 6 Months | 6.9 patient visits |
| Control - EMPOWER Clinic | Attendance/Retention From Baseline to 6 Months | 5.5 patient visits |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 0.9 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
Satisfaction measurements will be obtained through Satisfaction using Telehealth questionnaire.
Time frame: 6 Months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | I felt comfortable using technology for my online sessions. | Neutral | 4 Participants |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | I would like to have online sessions again. | Agree or Strongly Agree | 8 Participants |
| Experimental - Telehealth | Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | I would like to have online sessions again. | Neutral | 9 Participants |
| Experimental - Telehealth | Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | I would like to have online sessions again. | Disagree or Strongly Disagree | 0 Participants |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | I felt supported during the group sessions. | Agree or Strongly Agree | 14 Participants |
| Experimental - Telehealth | Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | I felt supported during the group sessions. | Neutral | 3 Participants |
| Experimental - Telehealth | Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | I felt supported during the group sessions. | Disagree or Strongly Disagree | 0 Participants |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | I was able to speak freely and express myself. | Neutral | 3 Participants |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | I liked the group style of the sessions. | Agree or Strongly Agree | 10 Participants |
| Experimental - Telehealth | Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | I liked the group style of the sessions. | Neutral | 7 Participants |
| Experimental - Telehealth | Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | I liked the group style of the sessions. | Disagree or Strongly Disagree | 0 Participants |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | 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 |
| Experimental - Telehealth | Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire | The session leader provided education that was easy to understand | Neutral | 2 Participants |
| Experimental - Telehealth | 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 |