Group Telehealth Weight Management Visits for Adolescents With Obesity

• ClinicalTrials.gov Identifier: NCT03508622
• Recruitment Status: Active, not recruiting
• First Posted: April 26, 2018
• Last Update Posted: June 16, 2022
• Sponsor: Children's Hospital Los Angeles
• Information provided by (Responsible Party): claudia borzutzky, Children's Hospital Los Angeles

Study Description

Brief Summary:

This pilot study aims to evaluate the feasibility and efficacy of a group telehealth model, compared with a standard multi-disciplinary, individualized, in-clinic weight management model, for treatment of adolescents with obesity.

Condition or disease	Intervention/treatment	Phase
Obesity, Childhood	Behavioral: Telehealth group sessions; Behavioral: Empower clinic	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pilot intervention using retrospective control group.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Group Telehealth Weight Management Visits for Adolescents With Obesity
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: September 30, 2022
• Estimated Study Completion Date: March 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Telehealth; This group will receive weight management treatment via 12 online group sessions, over 6 months. They will have Bluetooth-enabled scales that will allow them to transmit their weight data to the PI in between research visits. They will answer questionnaires and have research visits at baseline, 3 months, and 6 months.	Behavioral: Telehealth group sessions; 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; This retrospective control group received standard in-clinic individualized weight management with a multi-disciplinary group of providers, via 6 monthly clinic visits, over 6 months.	Behavioral: Empower clinic; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in anthropometric and clinical data [ Time Frame: 6 months ]
   change in absolute body mass index
2. Change in anthropometric and clinical data [ Time Frame: 6 months ]
   % of 95th percentile body mass index
3. Change in anthropometric and clinical data [ Time Frame: 6 months ]
   Labs: Glycosylated Hemoglobin; Hb A1c %
4. Change in anthropometric and clinical data [ Time Frame: 6 months ]
   Labs: Alanine Aminotransferase; ALT units/L
5. Change in anthropometric and clinical data [ Time Frame: 6 months ]
   Labs: Triglycerides; mg/dL
6. Change in anthropometric and clinical data [ Time Frame: 6 months ]
   Blood Pressure; (mm Hg)a

Secondary Outcome Measures :

1. Change in quality of life [ Time Frame: 6 months ]
   Quality of life measurements will be obtained will be obtained through "Youth Telehealth Pilot Study Survey" questionnaire.
2. Self-efficacy [ Time Frame: 6 months ]
   Self-efficacy measurements will be obtained through will be obtained through "Youth Telehealth Pilot Study Survey" questionnaire.
3. Satisfaction with care [ Time Frame: 6 months ]
   Satisfaction measurements will be obtained through "Satisfaction using Telehealth" questionnaire.
4. Attendance/Retention [ Time Frame: 6 months ]
   Attendance, no-show and same-day reschedules will be tallied

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

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.

Contacts and Locations

Locations

United States, California

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Sponsors and Collaborators

Children's Hospital Los Angeles

More Information

Publications:

Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.

Bashshur RL, Shannon GW, Smith BR, Alverson DC, Antoniotti N, Barsan WG, Bashshur N, Brown EM, Coye MJ, Doarn CR, Ferguson S, Grigsby J, Krupinski EA, Kvedar JC, Linkous J, Merrell RC, Nesbitt T, Poropatich R, Rheuban KS, Sanders JH, Watson AR, Weinstein RS, Yellowlees P. The empirical foundations of telemedicine interventions for chronic disease management. Telemed J E Health. 2014 Sep;20(9):769-800. doi: 10.1089/tmj.2014.9981. Epub 2014 Jun 26.

Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2.

Harris MA, Freeman KA, Duke DC. Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Diabetes Care. 2015 Aug;38(8):1427-34. doi: 10.2337/dc14-2469. Epub 2015 Jun 1.

Markowitz JT, Laffel LM. Transitions in care: support group for young adults with Type 1 diabetes. Diabet Med. 2012 Apr;29(4):522-5. doi: 10.1111/j.1464-5491.2011.03537.x.

Kulik N, Ennett ST, Ward DS, Bowling JM, Fisher EB, Tate DF. Brief report: A randomized controlled trial examining peer support and behavioral weight loss treatment. J Adolesc. 2015 Oct;44:117-23. doi: 10.1016/j.adolescence.2015.07.010. Epub 2015 Aug 7.

Tanofsky-Kraff M, Shomaker LB, Young JF, Wilfley DE. Interpersonal psychotherapy for the prevention of excess weight gain and eating disorders: A brief case study. Psychotherapy (Chic). 2016 Jun;53(2):188-94. doi: 10.1037/pst0000051.

• Responsible Party: claudia borzutzky, Clinical Associate Professor Pediatrics, Children's Hospital Los Angeles
• ClinicalTrials.gov Identifier: NCT03508622
• Other Study ID Numbers: RGA011089
• First Posted: April 26, 2018
• Last Update Posted: June 16, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Pediatric Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight