Obesity, ChildhoodNCT03508622
Group Telehealth Weight Management Visits for Adolescents With Obesity
A study testing Telehealth group sessions and Empower clinic in people with Obesity, Childhood, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Telehealth group sessions and Empower clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
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:
Read more
- 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.
Read the 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:
- Pilot a new care delivery model for CHLA EMPOWER patients using group telehealth visits.
- Assess the feasibility of using telehealth with adolescent patients
- Test the efficacy of group health education sessions using video conference technology
Hypotheses:
- Use of group health education sessions using video conference technology is a feasible, cost-effective care delivery model for adolescents being treated for obesity.
- Efficacy of this model will be comparable to, or better than, standard multi-disciplinary in-person visits. This will be measured by:
- 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
- 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.
- Conditions
- Obesity, Childhood
- Being tested
- Telehealth group sessions, Empower clinic
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth group sessionsBehavioural
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 clinicBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth | Experimental | 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. Receives: Behavioral: Telehealth group sessions |
| Empower | Other | 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. Receives: Behavioral: Empower clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to 6 Months
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
Measured: Baseline to 6 Months
Mean Change From Baseline to 6 Months in Glycosylated Hemoglobin
a blood test that measures the average blood glucose over three months
Measured: Baseline to 6 Months
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.
Measured: Baseline to 6 Months
Mean Change in Triglycerides From Baseline to 6 Months
Triglycerides will be assessed via blood tests and measured in milligrams per deciliter (mg/dL).
Measured: Baseline to 6 Months
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.
Measured: Baseline to 6 Months
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.
Measured: Baseline to 6 Months
Secondary outcomes (4)
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.
Measured: Baseline to 6 Months
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
Measured: Baseline to 6 Months
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
Satisfaction measurements will be obtained through "Satisfaction using Telehealth" questionnaire.
Measured: 6 Months
Attendance/Retention From Baseline to 6 Months
Attendance, no-show and same-day reschedules
Measured: Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Jan 2018
- Primary completion9 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Pilot intervention using retrospective control group.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Brenda Manzanarez, MS, RD, Children's Hospital Los Angeles
- Investigators
- Brenda Manzanarez, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508622
- Sponsor's protocol ID
- CHLA-17-00509
- Other IDs
- UL1TR001855
- Status last verified
- Sep 2025
- First submitted
- 6 Jan 2018
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
PubMed 18055651Bashshur RL, Shannon GW, Smith BR, Alverson DC, Antoniotti N, Barsan WG, Bashshur N, Brown EM, Coye MJ, Doarn CR, Ferguson S, Grigsby J, Krupinski EA, Kvedar JC, Linkous J, Merrell RC, Nesbitt T, Poropatich R, Rheuban KS, Sanders JH, Watson AR, Weinstein RS, Yellowlees P. The empirical foundations of telemedicine interventions for chronic disease management. Telemed J E Health. 2014 Sep;20(9):769-800. doi: 10.1089/tmj.2014.9981. Epub 2014 Jun 26.
PubMed 24968105Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2.
PubMed 20197355Harris MA, Freeman KA, Duke DC. Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Diabetes Care. 2015 Aug;38(8):1427-34. doi: 10.2337/dc14-2469. Epub 2015 Jun 1.
PubMed 26033508Markowitz JT, Laffel LM. Transitions in care: support group for young adults with Type 1 diabetes. Diabet Med. 2012 Apr;29(4):522-5. doi: 10.1111/j.1464-5491.2011.03537.x.
PubMed 22150392Kulik N, Ennett ST, Ward DS, Bowling JM, Fisher EB, Tate DF. Brief report: A randomized controlled trial examining peer support and behavioral weight loss treatment. J Adolesc. 2015 Oct;44:117-23. doi: 10.1016/j.adolescence.2015.07.010. Epub 2015 Aug 7.
PubMed 26265590Tanofsky-Kraff M, Shomaker LB, Young JF, Wilfley DE. Interpersonal psychotherapy for the prevention of excess weight gain and eating disorders: A brief case study. Psychotherapy (Chic). 2016 Jun;53(2):188-94. doi: 10.1037/pst0000051.
PubMed 27267503
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Telehealth Weight Management Visits for Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT03508622
- Acronym / sponsor ID
- CHLA-17-00509
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Pilot a new care delivery model for CHLA EMPOWER patients using group telehealth visits.
- Assess the feasibility of using telehealth with adolescent patients
- Test the efficacy of group health education sessions using video conference technology
Hypotheses:
- Use of group health education sessions using video conference technology is a feasible, cost-effective care delivery model for adolescents being treated for obesity.
- Efficacy of this model will be comparable to, or better than, standard multi-disciplinary in-person visits. This will be measured by:
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot intervention using retrospective control group.
| Arm | Type | Receives |
|---|---|---|
| Telehealth | Experimental | Behavioral: Telehealth group sessionsThis 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. |
| Empower | Other | Behavioral: Empower clinicThis 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth group sessionsTelehealth 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. | Behavioural | Telehealth |
| Empower clinicEmpower 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. | Behavioural | Empower |
Primary outcome
Mean Change From Baseline to 6 Months in Body Mass Index
Time frame: 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
Time frame: 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
Mean Change From Baseline to 6 Months in Glycosylated Hemoglobin
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 in Systolic Blood Pressure From Baseline to 6 Months
Time frame: 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.
4 secondary outcomes
Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1
Time frame: Baseline to 6 Months
Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.
Time frame: Baseline to 6 Months
Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire
Time frame: 6 Months
Attendance/Retention From Baseline to 6 Months
Time frame: Baseline to 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18055651Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
- Background: PubMed 24968105Bashshur RL, Shannon GW, Smith BR, Alverson DC, Antoniotti N, Barsan WG, Bashshur N, Brown EM, Coye MJ, Doarn CR, Ferguson S, Grigsby J, Krupinski EA, Kvedar JC, Linkous J, Merrell RC, Nesbitt T, Poropatich R, Rheuban KS, Sanders JH, Watson AR, Weinstein RS, Yellowlees P. The empirical foundations of telemedicine interventions for chronic disease management. Telemed J E Health. 2014 Sep;20(9):769-800. doi: 10.1089/tmj.2014.9981. Epub 2014 Jun 26.
- Background: PubMed 20197355Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2.
- Background: PubMed 26033508Harris MA, Freeman KA, Duke DC. Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Diabetes Care. 2015 Aug;38(8):1427-34. doi: 10.2337/dc14-2469. Epub 2015 Jun 1.
- Background: PubMed 22150392Markowitz JT, Laffel LM. Transitions in care: support group for young adults with Type 1 diabetes. Diabet Med. 2012 Apr;29(4):522-5. doi: 10.1111/j.1464-5491.2011.03537.x.
- Background: PubMed 26265590Kulik N, Ennett ST, Ward DS, Bowling JM, Fisher EB, Tate DF. Brief report: A randomized controlled trial examining peer support and behavioral weight loss treatment. J Adolesc. 2015 Oct;44:117-23. doi: 10.1016/j.adolescence.2015.07.010. Epub 2015 Aug 7.
- Background: PubMed 27267503Tanofsky-Kraff M, Shomaker LB, Young JF, Wilfley DE. Interpersonal psychotherapy for the prevention of excess weight gain and eating disorders: A brief case study. Psychotherapy (Chic). 2016 Jun;53(2):188-94. doi: 10.1037/pst0000051.
- Individual participant dataSharing planned: No
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Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda Manzanarez principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth group sessions and Empower clinic in people with Obesity, Childhood, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline to 6 Months in Body Mass Index (time frame: Baseline to 6 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03508622, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.