Clinical trial NCT03508622: Group Telehealth Weight Management Visits for Adolescents With Obesity
Official title: Group Telehealth Weight Management Visits for Adolescents With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 32
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pilot intervention using retrospective control group.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in anthropometric and clinical data
timeFrame: 6 months
measure: Change in anthropometric and clinical data
timeFrame: 6 months
measure: Change in anthropometric and clinical data
timeFrame: 6 months
measure: Change in anthropometric and clinical data
timeFrame: 6 months
measure: Change in anthropometric and clinical data
timeFrame: 6 months
measure: Change in anthropometric and clinical data
timeFrame: 6 months
Secondary outcomes:
measure: Change in quality of life
timeFrame: 6 months
measure: Self-efficacy
timeFrame: 6 months
measure: Satisfaction with care
timeFrame: 6 months
measure: Attendance/Retention
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Brenda Manzanarez
role: PRINCIPAL_INVESTIGATOR
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