Group Telehealth Weight Management Visits for Adolescents With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Mean Change From Baseline to 6 Months in Percentage of 95th Percentile Body Mass Index
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mean Change From Baseline to 6 Months in Percentage of 95th Percentile Body Mass Index
时间窗: 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
Mean Change From Baseline to 6 Months in Glycosylated Hemoglobin
时间窗: Baseline to 6 Months
a blood test that measures the average blood glucose over three months
Mean Change From Baseline to 6 Months in Alanine Aminotransferase
时间窗: 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.
Mean Change in Triglycerides From Baseline to 6 Months
时间窗: Baseline to 6 Months
Triglycerides will be assessed via blood tests and measured in milligrams per deciliter (mg/dL).
Mean Change in Systolic Blood Pressure From Baseline to 6 Months
时间窗: 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.
Mean Change From Baseline to 6 Months in Body Mass Index
时间窗: 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)
Mean Change in Diastolic Blood Pressure From Baseline to 6 Months
时间窗: 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.
次要结局
- Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1(Baseline to 6 Months)
- Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire(6 Months)
- Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.(Baseline to 6 Months)
- Attendance/Retention From Baseline to 6 Months(Baseline to 6 Months)
研究者
Brenda Manzanarez, MS, RD
Clinical Dietitian II
Children's Hospital Los Angeles