iEAT 2.0 Open Trial

NCT ID: NCT03383029

Last Updated: 2019-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-29
• Study Completion Date: 2019-04-25

Brief Summary

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.

Detailed Description

This study seeks to further the development of iEAT by including participants that demonstrated improvements in a previously conducted pilot study, and finalize the treatment manual to include the standardized decision rules to increase feeding demands, further integrate the multidisciplinary team (nutrition and speech pathology), and include supplementary sessions to better address individual treatment needs.

Investigators propose to enroll participants with chronic food refusal and formula or feeding tube dependence. Treatment will involve 10 biweekly outpatient appointments and 1 follow-up appointment of about 1 hour in length. Assessment and treatment will involve a multidisciplinary team including behavioral psychology, speech pathology and nutrition. Target behaviors including grams consumed, percent dependence on formula/feeding tube, and the clinical global impression scale, which will be assessed during a meal observation, 3-day food record, and evaluation with the dietitian and independent evaluator. Participants will be assessed pre-treatment, mid-treatment, and post-treatment and complete a one month follow-up to assess long term effects.

Conditions

Gastrointestinal Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iEAT

Children with food refusal will participate in the iEAT program.

Group Type: EXPERIMENTAL

iEAT Program

Intervention Type: BEHAVIORAL

The iEAT Program is a six-month long behavioral intervention consisting of 10 biweekly outpatient appointments of about 1 hour in length. The iEAT manual will guide behavioral intervention targeting severe feeding disorders and will involve some combination of escape extinction, reinforcement, and antecedent manipulation of food presentation to lessen the aversive quality of the meal.

Interventions

iEAT Program

The iEAT Program is a six-month long behavioral intervention consisting of 10 biweekly outpatient appointments of about 1 hour in length. The iEAT manual will guide behavioral intervention targeting severe feeding disorders and will involve some combination of escape extinction, reinforcement, and antecedent manipulation of food presentation to lessen the aversive quality of the meal.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Lindsey Burrell

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsey Burrell, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00099562

Identifier Type: -

Identifier Source: org_study_id