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Pediatric ObesityNCT01794546

Integrated Care for Pediatric Obesity Using Telehealth

A study testing Telehealth in people with Pediatric Obesity, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Pediatric Obesity
What is being tested?
Telehealth
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Feb 2013to Jan 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Wareham Pediatrics

    Wareham, Massachusetts, 02571

Other trials in United States

About this study

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.

Being tested
Telehealth
Keywords
pediatric obesity, telehealth
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelehealthBehavioural

    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.

Study groups in NCT01794546
Study groupRoleWhat they receive
Immediate TelehealthExperimentalThe "immediate" intervention group will receive the telehealth intervention during the first 6 months of the study timeline.
Receives: Behavioral: Telehealth
Wait List ControlActive comparatorThe "wait list" control group will receive the telehealth intervention during months 6 through 12 of the study timeline.
Receives: Behavioral: Telehealth

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI

    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.

    Measured: 12 months

Secondary outcomes (1)

  1. Satisfaction and compliance

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionOct 2014
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01794546
Sponsor's protocol ID
5781
Status last verified
Jul 2015
First submitted
15 Feb 2013
Last updated
28 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • Ebbeling CB, Feldman HA, Chomitz VR, Antonelli TA, Gortmaker SL, Osganian SK, Ludwig DS. A randomized trial of sugar-sweetened beverages and adolescent body weight. N Engl J Med. 2012 Oct 11;367(15):1407-16. doi: 10.1056/NEJMoa1203388. Epub 2012 Sep 21.

    PubMed 22998339

  • Ebbeling CB, Leidig MM, Feldman HA, Lovesky MM, Ludwig DS. Effects of a low-glycemic load vs low-fat diet in obese young adults: a randomized trial. JAMA. 2007 May 16;297(19):2092-102. doi: 10.1001/jama.297.19.2092.

    PubMed 17507345

  • Ebbeling CB, Leidig MM, Sinclair KB, Hangen JP, Ludwig DS. A reduced-glycemic load diet in the treatment of adolescent obesity. Arch Pediatr Adolesc Med. 2003 Aug;157(8):773-9. doi: 10.1001/archpedi.157.8.773.

    PubMed 12912783

  • Fleischman A, Kron M, Systrom DM, Hrovat M, Grinspoon SK. Mitochondrial function and insulin resistance in overweight and normal-weight children. J Clin Endocrinol Metab. 2009 Dec;94(12):4923-30. doi: 10.1210/jc.2009-1590. Epub 2009 Oct 21.

    PubMed 19846731

  • Fleischman A, Makimura H, Stanley TL, McCarthy MA, Kron M, Sun N, Chuzi S, Hrovat MI, Systrom DM, Grinspoon SK. Skeletal muscle phosphocreatine recovery after submaximal exercise in children and young and middle-aged adults. J Clin Endocrinol Metab. 2010 Sep;95(9):E69-74. doi: 10.1210/jc.2010-0527. Epub 2010 Jun 16.

    PubMed 20554709

  • McCormack SE, McCarthy MA, Farilla L, Hrovat MI, Systrom DM, Grinspoon SK, Fleischman A. Skeletal muscle mitochondrial function is associated with longitudinal growth velocity in children and adolescents. J Clin Endocrinol Metab. 2011 Oct;96(10):E1612-8. doi: 10.1210/jc.2011-1218. Epub 2011 Aug 10.

    PubMed 21832105

Questions about this trial

What is this clinical trial studying?

A study testing Telehealth in people with Pediatric Obesity, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01794546, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.

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