Clinical trial NCT05053438: Evaluating Hunger Manipulation During Feeding Intervention
Official title: Evaluating Hunger Manipulation as an Adjunct to Behavioral Intervention During Intensive Multidisciplinary Feeding Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Disorders
Feeding and Eating Disorders
Avoidant/Restrictive Food Intake Disorder
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Children's Healthcare of Atlanta
First posted: 2021-09-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18 months and 6 years of age;
* Present with dependence on enteral feeding for at least 80% of their daily caloric needs; - Have some prior experience consuming food orally;
* Demonstrate safe and functional swallowing;
* Present without neuromuscular conditions who are non-ambulatory (such as cerebral palsy);
* Have a body mass index in the 15th percentile, or greater;
* Present with no evidence of moderate or severe malnutrition (weight for age or BMI of age z-score \< -1) or recent weight loss;
* Engage in no severe problem behavior outside of mealtimes;
* Have a stable sleep schedule that will not interfere with therapeutic meals throughout the day;
* Caregivers must be English-speaking;
* Caregivers must be present for and participate in all treatment sessions.

Exclusion Criteria:

* Individuals with significant active medical conditions requiring oversight from a physician;
* Subjects who display severe problematic behaviors outside of the mealtime, necessitating intervention to specifically address those behaviors; -
* Subjects with medical, structural, or functional limitations preventing safe oral intake of pureed foods;
* Subjects with documented evidence of moderate to severe malnutrition or recent weight loss;
* Individuals with avoidance/restrictive food intake disorders who are not dependent on enteral feedings for at least 80% of their daily caloric needs.

Primary outcomes:
measure: Change in Percentage of oral intake
timeFrame: Up to 12 months
measure: Percent of patients achieving full wean and time to full wean
timeFrame: Measured in days with a time frame of up to 12 months
Secondary outcomes:
measure: Change in weight and BMI
timeFrame: Up to 12 months
measure: Mealtime performance.
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Center for Advanced Pediatrics
state: Georgia
city: Atlanta
country: United States
facility: Marcus Autism Center
state: Georgia
Study officials:
affiliation: Emory -Children's Ped Institute
name: Valerie Volket, PhD, BCBA-D
role: PRINCIPAL_INVESTIGATOR
References: