Group Telehealth Weight Management Visits for Adolescents With Obesity

NCT03508622 | Completed Results

• 2 other identifiers: CHLA-17-00509UL1TR001855
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (7)

• Mean Change From Baseline to 6 Months in Body Mass Index

  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)

  Baseline to 6 Months

• Mean Change From Baseline to 6 Months in Percentage of 95th Percentile Body Mass Index

  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

  Baseline to 6 Months

• Mean Change From Baseline to 6 Months in Glycosylated Hemoglobin

  a blood test that measures the average blood glucose over three months

  Baseline to 6 Months

• Mean Change From Baseline to 6 Months in Alanine Aminotransferase

  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.

  Baseline to 6 Months

• Mean Change in Triglycerides From Baseline to 6 Months

  Triglycerides will be assessed via blood tests and measured in milligrams per deciliter (mg/dL).

  Baseline to 6 Months

• Mean Change in Diastolic Blood Pressure From 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.

  Baseline to 6 Months

• Mean Change in Systolic Blood Pressure From 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.

  Baseline to 6 Months

Secondary Outcomes (4)

• Change in Quality of Life From Baseline to 6 Months Using Quality of Life Questionnaire #1

  Baseline to 6 Months

• Change in Quality of Life From Baseline to 6 Months Using the Quality of Life 2 (KINDL) Questionnaire.

  Baseline to 6 Months

• Satisfaction With Care at 6 Months Using Satisfaction Telehealth Questionnaire

  6 Months

• Attendance/Retention From Baseline to 6 Months

  Baseline to 6 Months

Study Arms (2)

Telehealth

EXPERIMENTAL

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

Empower

OTHER

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

Interventions

Telehealth group sessions BEHAVIORAL

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.

Telehealth

Empower clinic BEHAVIORAL

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.

Empower

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (7)

• 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.

  PMID: 18055651 BACKGROUND

• 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.

  PMID: 24968105 BACKGROUND

• 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.

  PMID: 20197355 BACKGROUND

• 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.

  PMID: 26033508 BACKGROUND

• 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.

  PMID: 22150392 BACKGROUND

• 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.

  PMID: 26265590 BACKGROUND

• 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.

  PMID: 27267503 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study is limited by a relatively small sample size (intervention n = 31, control n=33) and short duration of follow-up (6 months). Study did not reach target number to achieve target power and statistical reliability. Therefore, results should be interpreted with caution until a larger scale and more rigorous study is replicated.

Results Point of Contact

• Title: Brenda Manzanarez
• Organization: Children's Hospital Los Angeles

bmanzanarez@chla.usc.edu

323/361-8245

Study Officials

• Brenda Manzanarez

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Dietitian II

Model Details: Pilot intervention using retrospective control group.

Study Record Dates

• First Submitted: January 6, 2018
• First Posted: April 26, 2018
• Study Start: January 1, 2018
• Primary Completion: April 9, 2021
• Study Completion: May 1, 2021
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)