NCT05053438

Evaluating Hunger Manipulation During Feeding Intervention

Evaluating Hunger Manipulation as an Adjunct to Behavioral Intervention During Intensive Multidisciplinary Feeding Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Months – 6 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The recognized standard of care for children dependent on feeding tubes is intensive multidisciplinary feeding intervention (IMFI) involving a professional team that includes psychologists, physicians, nurse practitioners, registered dietitian nutritionists, and speech-language pathologists/occupational therapists working together in inpatient or day hospital settings. A meta-analysis of 11 studies involving intensive, multidisciplinary intervention reported that 71% (95% CI, 54%-83%) of 454 patients successfully weaned from feeding tube dependence at discharge from inpatient or intensive day treatment programs. Treatment gains were maintained following discharge, with 80% (95% CI, 66%-89%) of 414 patients successfully weaned from tube feedings at last follow-up. The most common treatment approaches documented by the meta-analysis involved behavioral intervention and tube weaning (hunger manipulation - evoking a state of hunger to encourage oral consumption by rapidly weaning from the tube). The review highlighted the lack of consensus among clinicians and researchers regarding the criteria for, rate of, and timing of weaning from enteral feedings. As a result, the authors concluded that the relative contribution of aggressive tube weaning as a standalone or adjunctive therapy to behavioral intervention remains uncertain. 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 as an adjunct to our standard model of behavioral intervention within the study team's IMFI program, 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

Type	Name	Description
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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-10-18
• Completion: 2023-10-18
• First posted: 2021-09-22
• Last updated: 2023-11-28

Locations

2 sites across 1 country: United States