IT-Supported Early Treatment Of Childhood Overweight

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.

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Key information

Conditions

Childhood Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Technology Based Obesity Intervention

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telephone Linked Care-HEAT (TLC-HEAT)

Behavioral

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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HEAT

Important dates

Study start: 2005
Primary completion: 2010
First posted: Aug 25, 2010
Registry last updated: Aug 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed