Group Telehealth Weight Management Visits for Adolescents With Obesity

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 appointments using telehealth

Hypotheses:

1. Use of shared medical appointments via telehealth 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 telehealth sessions once a month. It is widely recognized that teens' families
must be willing to make changes in order to increase their child's chances for success
in weight management. More practically, most food is purchased and prepared by parents
or older family members, so it is essential that they receive education and support as
well.

- Intervention group participants will also be given Bluetooth enabled scales and will be
asked to weigh in once a month. Comorbidities such as insulin resistance, dyslipidemia,
PCOS, and NAFLD will be managed remotely through prescriptions and follow-up lab work
and/or imaging coordinated with the patients' primary care physicians.

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.

Inclusion Criteria:

1. class 2 or 3 obesity OR

2. 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:

1. significant intellectual or neurodevelopmental disability

2. inability to stand on a scale independently without assistance or use of an assistive
device

3. non-English speaking

4. baseline weight > 165 kg

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. Patients must be able to stand on scales on their own in order to generate
accurate weight and BMI measurements. Lastly, patients with baseline weight > 165 kg will
not be able to participate due to the maximum weight limit on the loaned wifi enabled
scales.