Integrated Care for Pediatric Obesity Using Telehealth

July 27, 2015 updated by: Cara Ebbeling, Boston Children's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Wareham, Massachusetts, United States, 02571
        • Wareham Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Telehealth
The "immediate" intervention group will receive the telehealth intervention during the first 6 months of the study timeline.
Behavioral: Telehealth
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.
Active Comparator: Wait List Control
The "wait list" control group will receive the telehealth intervention during months 6 through 12 of the study timeline.
Behavioral: Telehealth
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction and compliance
Time Frame: 12 months
Hypotheses. 1) Satisfaction with the intervention will be higher at 6 months for the "immediate" intervention group vs. "wait list" control group. 2) Subjects in both groups (during either the "immediate" or "delayed" telehealth intervention, depending on random assignment) will complete a higher percentage of scheduled telehealth intervention visits (≥75%) when compared to published data of completed in-person visits from a national survey of established weight management clinics in children's hospitals.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Cara B. Ebbeling, PhD, Boston Children's Hospital
  • Principal Investigator: Amy D Fleischman, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 15, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5781

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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