Back to resultsIT-Supported Early Treatment Of Childhood Overweight (HEAT)
Primary Purpose
Childhood Obesity, Technology Based Obesity Intervention
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telephone Linked Care-HEAT (TLC-HEAT)
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring Childhood Obesity, Obesity Intervention
Eligibility Criteria
Inclusion Criteria:
Children will be enrolled in the study if they meet a set of eligibility criteria which includes:
- 0-3 BMI points above the 95th %ile for age and gender
- age 9-12 years old
- a PCP at BMC
- an English speaking child and parent (based on interviewer assessment).
Exclusion Criteria:
Children will be considered ineligible for the study if they:
- have a health condition for which dietary recommendations in TLC-HEAT would be contraindicated
- have cognitive impairment (not in a mainstream academic class in school)
- have a terminal illness, current or former diagnosis of an eating disorder, or other diagnosis that the PCP deems should exclude them from participation
- plan to move away from the Boston area in less than 12 months
- are participating in another clinical weight treatment program.
- Initial screening will be done by research assistants over the phone.
Sites / Locations
- Boston Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01188616
First Posted
August 24, 2010
Last Updated
August 24, 2010
Sponsor
Boston Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01188616
Brief Title
IT-Supported Early Treatment Of Childhood Overweight
Acronym
HEAT
Official Title
Automated Self-management System to Promote Healthy Eating and Activity in Overweight Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Technology Based Obesity Intervention
Keywords
Childhood Obesity, Obesity Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Telephone Linked Care-HEAT (TLC-HEAT)
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children will be enrolled in the study if they meet a set of eligibility criteria which includes:
0-3 BMI points above the 95th %ile for age and gender
age 9-12 years old
a PCP at BMC
an English speaking child and parent (based on interviewer assessment).
Exclusion Criteria:
Children will be considered ineligible for the study if they:
have a health condition for which dietary recommendations in TLC-HEAT would be contraindicated
have cognitive impairment (not in a mainstream academic class in school)
have a terminal illness, current or former diagnosis of an eating disorder, or other diagnosis that the PCP deems should exclude them from participation
plan to move away from the Boston area in less than 12 months
are participating in another clinical weight treatment program.
Initial screening will be done by research assistants over the phone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Adams, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Learn more about this trial
IT-Supported Early Treatment Of Childhood Overweight
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