Integrated Care for Pediatric Obesity Using Telehealth

NCT01794546 | Completed

• 1 other identifier: 5781
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is perhaps the most urgent public health crisis in pediatrics. Thus, managing childhood obesity is a top priority among pediatricians in primary care settings. However, effective treatment typically is multidisciplinary, and most practices currently do not have the infrastructure for coordinating integrated care. With the advent of the Affordable Care Act (ACA), innovative systems for building multidisciplinary teams to provide integrated care through a patient-centered medical home will be at a strategic advantage. The use of electronic technologies for delivering health-related information or services, known as telehealth, is an innovation with the potential to streamline integrated care and transform interventions for chronic diseases. We propose a pilot study to evaluate telehealth for treating pediatric obesity in collaboration with a community practice (Wareham Pediatrics). Patients aged 10 to 17 years who participate in the telehealth intervention study (N=40) will be randomly assigned to an "immediate" intervention group or a "wait list" control group. Subjects in the "immediate" intervention group will begin the 6-month telehealth intervention at the time of enrollment in the study and then receive general patient/family counseling from their primary care providers (PCPs) at routine office visits during a 6-month follow-up period. Those in the "wait list" control group will receive general patient/family counseling from their PCPs for 6 months followed by the telehealth intervention for 6 months. Thus, the total duration of participation in the study for each subject will be 12 months. The telehealth intervention will include dietary, physical activity, and behavioral management counseling provided by videoconferencing from the OWL clinical providers at Boston Children's Hospital to children in their homes, or at a telehealth station at Wareham Pediatrics.

Conditions

Pediatric Obesity

Keywords

pediatric obesity; telehealth

Outcome Measures

Primary Outcomes (1)

• BMI

  Hypotheses. 1) The mean decrease in body mass index (BMI) percentile at 6 months (primary outcome) will be greater among subjects who are randomly assigned to the "immediate" intervention group compared to the "wait list" control group. 2) For children in the "immediate" intervention group, the intervention effect on BMI percentile will be maintained during a 6-month follow-up period. 3) For children in the "wait list" control group, BMI percentile will improve during the 6-month delayed telehealth intervention period compared to the initial 6-month control period.

  12 months

Secondary Outcomes (1)

• Satisfaction and compliance

  12 months

Study Arms (2)

Immediate Telehealth

EXPERIMENTAL

The "immediate" intervention group will receive the telehealth intervention during the first 6 months of the study timeline.

Behavioral: Telehealth

Wait List Control

ACTIVE COMPARATOR

The "wait list" control group will receive the telehealth intervention during months 6 through 12 of the study timeline.

Behavioral: Telehealth

Interventions

Telehealth BEHAVIORAL

Telehealth visits will alternate between a dietitian and behavioral medicine provider for either 30 minutes or 1 hour. Over a 6-month period, 12 telehealth sessions will be scheduled for each participant. The dietitian will provide dietary and physical activity recommendations, and the behavioral medicine provider will counsel on strategies for achieving specific goals. Applying a Chronic Care Model, self-management support will be augmented by linkages to community resources.

Immediate Telehealth; Wait List Control

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 10 to 17 years
• BMI ≥95th percentile for age and sex
• No known significant obesity comorbidity or cause requiring urgent medical evaluation or treatment in a subspecialty program other than an obesity program
• No known physical limitations to changes in diet or activity level (i.e., concern for cardiac disease, primary gastrointestinal disease, or orthopedic concerns)
• Patient at Wareham Pediatrics practice

You may not qualify if:

• Unstable home environment (homeless, temporary living situation, lack of working phone or electricity)
• Inability to actively participate in treatment (developmental delay, nonverbal, severe psychiatric illness).
• Physician diagnosis of a major medical illness or eating disorder.
• Chronic use of any medication or supplement that may affect study outcomes.
• Another member of the family (i.e., first degree relative) or household participating in the study.
• Planning to relocate from current area of residence during the proposed timeframe for study participation

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Wareham Pediatrics

Wareham, Massachusetts, 02571, United States

Location

Related Publications (6)

• Ebbeling CB, Feldman HA, Chomitz VR, Antonelli TA, Gortmaker SL, Osganian SK, Ludwig DS. A randomized trial of sugar-sweetened beverages and adolescent body weight. N Engl J Med. 2012 Oct 11;367(15):1407-16. doi: 10.1056/NEJMoa1203388. Epub 2012 Sep 21.

  PMID: 22998339 BACKGROUND

• Ebbeling CB, Leidig MM, Feldman HA, Lovesky MM, Ludwig DS. Effects of a low-glycemic load vs low-fat diet in obese young adults: a randomized trial. JAMA. 2007 May 16;297(19):2092-102. doi: 10.1001/jama.297.19.2092.

  PMID: 17507345 BACKGROUND

• Ebbeling CB, Leidig MM, Sinclair KB, Hangen JP, Ludwig DS. A reduced-glycemic load diet in the treatment of adolescent obesity. Arch Pediatr Adolesc Med. 2003 Aug;157(8):773-9. doi: 10.1001/archpedi.157.8.773.

  PMID: 12912783 BACKGROUND

• Fleischman A, Kron M, Systrom DM, Hrovat M, Grinspoon SK. Mitochondrial function and insulin resistance in overweight and normal-weight children. J Clin Endocrinol Metab. 2009 Dec;94(12):4923-30. doi: 10.1210/jc.2009-1590. Epub 2009 Oct 21.

  PMID: 19846731 BACKGROUND

• Fleischman A, Makimura H, Stanley TL, McCarthy MA, Kron M, Sun N, Chuzi S, Hrovat MI, Systrom DM, Grinspoon SK. Skeletal muscle phosphocreatine recovery after submaximal exercise in children and young and middle-aged adults. J Clin Endocrinol Metab. 2010 Sep;95(9):E69-74. doi: 10.1210/jc.2010-0527. Epub 2010 Jun 16.

  PMID: 20554709 BACKGROUND

• McCormack SE, McCarthy MA, Farilla L, Hrovat MI, Systrom DM, Grinspoon SK, Fleischman A. Skeletal muscle mitochondrial function is associated with longitudinal growth velocity in children and adolescents. J Clin Endocrinol Metab. 2011 Oct;96(10):E1612-8. doi: 10.1210/jc.2011-1218. Epub 2011 Aug 10.

  PMID: 21832105 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Cara B. Ebbeling, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Amy D Fleischman, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, New Balance Foundation Obesity Prevention Center

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: February 20, 2013
• Study Start: February 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

US (1)