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IT-Supported Early Treatment Of Childhood Overweight (HEAT)

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01188616
First received: August 24, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Childhood Obesity
Technology Based Obesity Intervention
 Behavioral: Telephone Linked Care-HEAT (TLC-HEAT)
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Automated Self-management System to Promote Healthy Eating and Activity in Overweight Children

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Study Start Date: July 2005
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Telephone Linked Care-HEAT (TLC-HEAT)
    A primary care intervention linked with Telephone Linked Care-HEAT (TLC-HEAT), and delivered through an electronic health record (EHR). The HEAT system will guide children in the early stages of overweight toward healthy weight management and assist the child's parent(s) and primary care provider (PCP) to support the child's efforts.
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.

  Eligibility

Ages Eligible for Study:   9 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188616

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: William Adams, MD Boston Medical Center
  More Information

No publications provided

Responsible Party: William Adams, MD, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01188616     History of Changes
Other Study ID Numbers: H-24963, R21HD050939-01
Study First Received: August 24, 2010
Last Updated: August 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Childhood Obesity
Obesity Intervention

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013