Evaluating Hunger Manipulation During Feeding Intervention

NCT05053438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-11-28

No results posted yet for this study

Summary

The primary objective of this study is to determine to what extent hunger provocation, via rapid weaning from enteral feedings, is acceptable and feasible and to evaluate the effect of this intervention when used in an intensive multidisciplinary feeding intervention (IMFI) model of treatment (standard care), for individuals with Avoidant Food Intake Disorder (ARFID) who are dependent on enteral feedings to meet their daily caloric needs.

Conditions

  • Feeding Disorders
  • Feeding and Eating Disorders
  • Avoidant/Restrictive Food Intake Disorder

Interventions

BEHAVIORAL

Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of Care

Standard care involves behavioral intervention delivered during admission Intensive Multidisciplinary Intervention. Patients admitted to the program will participate in four therapeutic meals per day, five days per week (Monday through Friday). The behavioral intervention involves a standard sequence of reinforcement techniques, bite persistence (a.k.a., contingency contacting, escape extinction), and stimulus fading/antecedent manipulation protocols. Parent training will be the central method for structuring meals and transferring treatment gains from the clinic to the home setting. The sequence and steps for parents training will follow a sequential, proficiency-based process, with caregivers transitioning to serve as the primary feeder by discharge. Management of tube wean in our standard of care involves reducing tube feeding calories based on oral intake at a 1:1 ratio.

BEHAVIORAL

Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaning

The experimental arm combines standard care with a rapid tube wean. On day 1, the dietitian will meet with the caregiver to determine the usual tube feeding schedule. The dietitian will then create a tube feeding plan that meets 70% of the child's caloric needs (a 30% reduction).On day 3, if a patient has moved past a rice size bite volume in therapeutic meals, the patient's tube feedings will be further reduced to meet 50% of needs. All schedules and documents will be updated accordingly. After the 50% tube wean cut, the dietitian will use a regular tube wean sheet to provide credit for oral intake for the remainder of admission.

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    collaborator OTHER
  • Emory University

    lead OTHER

Principal Investigators

  • Valerie Volket, PhD, BCBA-D · Emory -Children's Ped Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-10-18
Completion
2023-10-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05053438 on ClinicalTrials.gov