Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
NCT Number: NCT03508622
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.
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Notify Me14 year–18 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90027, United States
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:
Hypotheses:
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
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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)
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
Time frame: Baseline to 6 Months
a blood test that measures the average blood glucose over three months
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.
Time frame: Baseline to 6 Months
Triglycerides will be assessed via blood tests and measured in milligrams per deciliter (mg/dL).
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.
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.
Time frame: Baseline to 6 Months
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.
Time frame: Baseline to 6 Months
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
Time frame: 6 Months
Satisfaction measurements will be obtained through "Satisfaction using Telehealth" questionnaire.
Time frame: Baseline to 6 Months
Attendance, no-show and same-day reschedules
Children's Hospital Los Angeles
Other
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