Evaluating Hunger Manipulation During Feeding Intervention
Condition: Feeding Disorders; Feeding and Eating Disorders; Avoidant/Restrictive Food Intake Disorder
MeSH terms: Feeding and Eating Disorders; Avoidant Restrictive Food Intake Disorder
Study type: Interventional

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.
    

Intervention name(s): Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of Care; Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaning
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): Standard of Care; Nutrition; Intervention Group; Rapid Tube Weaning
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized 1:1 to intensive feeding intervention (standard care) or intensive feeding intervention (standard care) + rapid tube weaning study groups using permuted blocks of size 2 or 4.
Masking: Single (Investigator)
Primary purpose: Treatment