Group Telehealth Weight Management Visits for Adolescents With Obesity

Study Overview
=================
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: 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: 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 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.

Official Title
-----------------
Group Telehealth Weight Management Visits for Adolescents With Obesity

Conditions
-----------------
Obesity, Childhood

Intervention / Treatment
-----------------
* Behavioral: Telehealth group sessions
* Behavioral: Empower clinic


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot intervention using retrospective control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth<br>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. | Behavioral: Telehealth group sessions<br>* 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.<br>|
| Other: Empower<br>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. | Behavioral: Empower clinic<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anthropometric and clinical data | change in absolute body mass index | 6 months | 
| Change in anthropometric and clinical data | % of 95th percentile body mass index | 6 months | 
| Change in anthropometric and clinical data | Labs: Glycosylated Hemoglobin; Hb A1c % | 6 months | 
| Change in anthropometric and clinical data | Labs: Alanine Aminotransferase; ALT units/L | 6 months | 
| Change in anthropometric and clinical data | Labs: Triglycerides; mg/dL | 6 months | 
| Change in anthropometric and clinical data | Blood Pressure; (mm Hg)a | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | Quality of life measurements will be obtained will be obtained through Youth Telehealth Pilot Study Survey questionnaire. | 6 months | 
| Self-efficacy | Self-efficacy measurements will be obtained through will be obtained through Youth Telehealth Pilot Study Survey questionnaire. | 6 months | 
| Satisfaction with care | Satisfaction measurements will be obtained through Satisfaction using Telehealth questionnaire. | 6 months | 
| Attendance/Retention | Attendance, no-show and same-day reschedules will be tallied | 6 months |