IT-Supported Early Treatment Of Childhood Overweight

Childhood Obesity Clinical Trial

— HEAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188616
• Other study ID #: H-24963
• Secondary ID: R21HD050939-01
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2010
• Last updated: August 24, 2010
• Start date: July 2005

Study information

• Verified date: August 2010
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 12 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity
• Technology Based Obesity Intervention

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States,