Group Telehealth Weight Management Visits for Adolescents With Obesity
Condition: Obesity, Childhood
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

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.
    

Intervention name(s): Telehealth group sessions; Empower clinic
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Pilot intervention using retrospective control group.
Masking: None (Open Label)
Primary purpose: Treatment