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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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