iEAT 2.0 Open Trial

NCT03383029 | Completed

• 1 other identifier: IRB00099562
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Disorders

Keywords

Nutrition; Behavioral

Outcome Measures

Primary Outcomes (4)

• Change in Percent Oral Intake

  Oral intake will be assessed through the three-day food diary on which parents will record the child's daily intake. The percent of needs consumed orally will be reported.

  Baseline, Post-Intervention (Week 20)

• Change in Total Oral Grams Consumed During Meal

  Total oral grams consumed during a meal will be rated by trained observers captured by the meal observation form and collected during study visits.

  Baseline, Post-Intervention (Week 20)

• Change in Percent Needs Met by Formula or Feeding Tube

  Formula and feeding tube intake will be assessed through the three-day food diary on which parents will record the child's daily intake. The percent of needs consumed via bottle or tube will be reported.

  Baseline, Post-Intervention (Week 20)

• Clinical Global Impression Scale - Improvement (CGI-I) Score

  The CGI-I is a seven-point scale measure of overall change from baseline. Scores will be ranked from 1 (Very Much Improved) through 4 (Unchanged) to 7 (Very Much Worse). Scores of "Much Improved" or "Very Much Improved" will be used to define positive responses; all other scores will indicate negative responses. Total scores range from 1 to 7; where 1 indicates the most improvement and 7 indicates greatest worsening.

  Post-Intervention (Week 20)

Secondary Outcomes (1)

• Change in Parenting Stress Index (PSI) Score

  Baseline, Post-Intervention (Week 20)

Study Arms (1)

iEAT

EXPERIMENTAL

Children with food refusal will participate in the iEAT program.

Behavioral: iEAT Program

Interventions

iEAT Program 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.

iEAT

Eligibility Criteria

• Age: 12 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Behavior

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Lindsey Burrell, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 26, 2017
• Study Start: November 29, 2017
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: June 21, 2019

Record last verified: 2019-06

Locations

US (1)