Clinical trial NCT03383029: iEAT 2.0 Open Trial
Official title: Evaluation of the Feasibility and Preliminary Efficacy of the Parent-Mediated Integrated Eating Aversion Treatment (iEAT) Manual
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Disorders
Keywords: Nutrition
Behavioral
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Percent Oral Intake
timeFrame: Baseline, Post-Intervention (Week 20)
measure: Change in Total Oral Grams Consumed During Meal
timeFrame: Baseline, Post-Intervention (Week 20)
measure: Change in Percent Needs Met by Formula or Feeding Tube
timeFrame: Baseline, Post-Intervention (Week 20)
measure: Clinical Global Impression Scale - Improvement (CGI-I) Score
timeFrame: Post-Intervention (Week 20)
Secondary outcomes:
measure: Change in Parenting Stress Index (PSI) Score
timeFrame: Baseline, Post-Intervention (Week 20)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Lindsey Burrell, MD
role: PRINCIPAL_INVESTIGATOR
References: