iEAT 2.0 Open Trial

Completed · Not applicable

Conditions studied: Gastrointestinal Disorders

In brief

The purpose of this study is to learn more about the eating behaviors of children with chronic food refusal. Specifically, investigator's aim to see how the integrated Eating Aversion Treatment (iEAT) may affect a child's food consumption. The manual is a structured multidisciplinary treatment, including a psychologist and dietitian with consultation from a speech-language pathologist. The treatment is designed to increase the volume of foods a child eats and decrease their reliance on a feeding tube or formula. The manual includes informational handouts, data collection forms, and instructions to guide the increase in feeding demands while reducing reliance on formula to meet a child's nutritional needs. Children with chronic food refusal will participate in this study at the Marcus Autism Center. All children who enroll will receive the iEAT treatment. This involves 10 bi-weekly sessions that last approximately one hour, over the course of 5 months and a 1 month follow-up visit. Therefore, the study will last a total of 6 months.

Key facts

Study ID

NCT03383029

Run by

Emory University

People needed

15

Starts

2017-11-29

Expected to finish

2019-04-25

Last updated by the study team

2019-06-21

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Present with partial food refusal as evidenced by greater than 75% of caloric needs met by bottle, formula, or tube feedings
• Have a medical history significant for an organic factor (e.g., gastrointestinal issues) which influenced the development of feeding concern
• Safe to consume up to 100% of his/her needs orally
• Parents of subjects must be English literate
• Ability to complete at least 2 structured meals each day

You may not qualify if…

• Active medical diagnoses requiring hospitalization or significant oversight from a physician
• Active medical, structural, or functional limitations preventing safe oral intake of pureed foods

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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