Clinical Trial: Integrated Care for Pediatric Obesity Using Telehealth

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Integrated Care for Pediatric Obesity Using Telehealth

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

Detailed Summary:
Sponsor: Boston Children’s Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Boston Children’s Hospital

Dates:
Date Received: February 15, 2013
Date Started: February 2013
Date Completion:
Last Updated: July 27, 2015
Last Verified: July 2015