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 Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: October 2014
- 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.
Arms, Groups and Cohorts
- Experimental: Immediate Telehealth
- The “immediate” intervention group will receive the telehealth intervention during the first 6 months of the study timeline.
- Active Comparator: Wait List Control
- The “wait list” control group will receive the telehealth intervention during months 6 through 12 of the study timeline.
Clinical Trial Outcome Measures
- 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.
- 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 10 Years
Maximum Age: 17 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Boston Children’s Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Cara Ebbeling, Associate Director, New Balance Foundation Obesity Prevention Center – Boston Children’s Hospital
- Overall Official(s)
- Cara B. Ebbeling, PhD, Principal Investigator, Boston Children’s Hospital
- Amy D Fleischman, MD, Principal Investigator, Boston Children’s Hospital
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