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Completed Not applicable Interventional Accepts healthy volunteers

Technology-supported Behavioral Feeding Intervention

ClinicalTrials.gov ID: NCT02119910

Public ClinicalTrials.gov record NCT02119910. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Development of a Manual-based, Technology-supported, Behavioral Feeding Intervention

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This investigation proposes to examine the effectiveness of a technology supported treatment manual for pediatric feeding disorders. Children with pediatric feeding disorders display intense avoidance behaviors (e.g., crying, tantrums, and disruptions) that prevent appropriate nutritional intake during meals and lead to a number of negative and potentially life threatening medical outcomes, including chronic malnutrition, growth retardation, and placement of a feeding tube. To date, behavioral intervention involving extinction-based procedures represents the only treatment for pediatric feeding disorders supported by research to improve mealtime behaviors. Due to the chronic and extreme nature of food refusal, treatment typically requires intensive, daily intervention conducted at highly specialized clinics to improve feeding behaviors. The cost and duration of intervention can total as much as $60,000 per child requiring up to 6 to 8 weeks, respectively. The potential for serious consequences associated with chronic food refusal, combined with the high cost of treatment, intensifies the need to identify means to disseminate effective treatment approaches to the broader community of healthcare providers. The proposed study represents the first attempt to systematically investigate the use of a treatment manual to address chronic food aversion through a randomized, waitlist control trial in children treated at the Marcus Autism Center's Pediatrics Feeding Disorders Program. This study will involve a total of 20 participants randomly assigned to experimental conditions: technology supported treatment manual or waitlist control group (10 in each group). Children assigned to the waitlist control group will receive the technology supported treatment manual after the specified time on the waitlist. All participants will receive the same behavioral protocol involving three treatment sessions per day (45 minutes in length), for a total of 15 sessions across five consecutive days. Data will be collected on feeding behaviors during each treatment session and at follow-up using trained observers to collect data on mealtime behaviors, including acceptance, swallowing, disruption, expulsion, and grams consumed. This type of data collection and treatment is standard practice in the feeding disorders program; however, the use of a touch screen application for data capture with integrated manual is novel to this project.

Study identification

NCT ID
NCT02119910
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Emory University
Other
Enrollment
20 participants

Conditions and interventions

Eligibility (public fields only)

Age range
12 Months to 6 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2013
Primary completion
Nov 30, 2014
Completion
Feb 28, 2015
Last update posted
Mar 16, 2015

2014 – 2015

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
The Marcus Autism Center Atlanta Georgia 30329

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02119910, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 16, 2015 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT02119910 live on ClinicalTrials.gov.

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