IT-Supported Early Treatment Of Childhood Overweight (HEAT)

August 24, 2010 updated by: Boston Medical Center

Automated Self-management System to Promote Healthy Eating and Activity in Overweight Children

The goal of this exploratory/ developmental study is to develop and evaluate an integrated information system, Healthy Eating and Activity Today (HEAT), for promoting self-care in overweight children. HEAT is comprised of two components: 1)Telephone Linked Care-HEAT (TLC-HEAT), a self-care intervention delivered at home through totally automated telephone conversations; and 2) Primary Care-HEAT (PC-HEAT), a primary care intervention linked with TLC-HEAT and delivered through an electronic health record (EHR). The HEAT system will guide children in the early stages of overweight, i.e., children with Body Mass Index (BMI) 0-3 BMI points above the 95th percentile for age and gender, toward healthy weight management and assist the child's parent(s) and primary care provider (PCP) to support the child's efforts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For this project we will: 1) develop TLC-HEAT for use by children in the earliest stage of overweight and their parents; 2) integrate TLC-HEAT with an electronic health record to provide child- and parent-reported behavior summaries combined with evidence-based decision support to primary care providers (PCPs) at the point-of-care (PC-HEAT); and 3) conduct a pilot study of the combined HEAT system to explore the appropriateness of conducting a larger, randomized clinical trial in the future.

Study Type

Interventional

Phase

  • Phase 2

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
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

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

Ages Eligible for Study

9 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children will be enrolled in the study if they meet a set of eligibility criteria which includes:

    1. 0-3 BMI points above the 95th %ile for age and gender
    2. age 9-12 years old
    3. a PCP at BMC
    4. an English speaking child and parent (based on interviewer assessment).

Exclusion Criteria:

  • Children will be considered ineligible for the study if they:

    1. have a health condition for which dietary recommendations in TLC-HEAT would be contraindicated
    2. have cognitive impairment (not in a mainstream academic class in school)
    3. have a terminal illness, current or former diagnosis of an eating disorder, or other diagnosis that the PCP deems should exclude them from participation
    4. plan to move away from the Boston area in less than 12 months
    5. are participating in another clinical weight treatment program.
  • Initial screening will be done by research assistants over the phone.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

July 1, 2005

Primary Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

August 24, 2010

First Submitted That Met QC Criteria

August 24, 2010

First Posted (ESTIMATE)

August 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2010

Last Update Submitted That Met QC Criteria

August 24, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24963
  • R21HD050939-01 (NIH)

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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