ClinicalTrials.Veeva

Menu

Integrated Care for Pediatric Obesity Using Telehealth

Boston Children's Hospital logo

Boston Children's Hospital

Status

Completed

Conditions

Pediatric Obesity

Treatments

Behavioral: Telehealth

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

40 participants in 2 patient groups

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems