search
Back to results

Evaluating Hunger Manipulation During Feeding Intervention

Primary Purpose

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

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of Care
Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaning
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding Disorders

Eligibility Criteria

18 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Advanced Pediatrics
  • Marcus Autism Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intensive Multidisciplinary Intervention (Standard Care)

Intensive Multidisciplinary Intervention (Standard Care) + Hunger provocation (Rapid Tube Wean)

Arm Description

Children with a history of chronic food refusal will be randomized to receive the standard of care. The standard of care for tube wean is to accomplish the balance between enteral supplementation and oral intake, the tube feeding regimen will follow the schedule of therapeutic meals (e.g., mid-day supplementation occurs after morning therapeutic meals).

Children with a history of chronic food refusal will be randomized to receive the experimental arm that combines standard care with rapid tube wean. All schedules and documents will be updated accordingly. After the 50% tube wean cut, the dietitian will use regular tube wean sheet to provide credit for oral intake for remainder of admission.

Outcomes

Primary Outcome Measures

Change in Percentage of oral intake
The percent oral intake will be calculated by dividing calories consumed during therapeutic meals by the daily calorie target.
Percent of patients achieving full wean and time to full wean
% of participants reaching 100% of their caloric needs by mouth

Secondary Outcome Measures

Change in weight and BMI
Weight will be measured in kilograms (Kg) on a digital scale; height measured in cm; BMI calculated from weight and height into kg/m2, z-score, and percentile
Mealtime performance.
Bite acceptance, rapid swallowing, and inappropriate mealtime behavior

Full Information

First Posted
September 1, 2021
Last Updated
September 19, 2023
Sponsor
Emory University
Collaborators
Children's Healthcare of Atlanta
search

1. Study Identification

Unique Protocol Identification Number
NCT05053438
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
October 14, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Children's Healthcare of Atlanta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Disorders, Feeding and Eating Disorders, Avoidant/Restrictive Food Intake Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
The allocation pattern is concealed to the investigators and therapists providing intervention.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Multidisciplinary Intervention (Standard Care)
Arm Type
Active Comparator
Arm Description
Children with a history of chronic food refusal will be randomized to receive the standard of care. The standard of care for tube wean is to accomplish the balance between enteral supplementation and oral intake, the tube feeding regimen will follow the schedule of therapeutic meals (e.g., mid-day supplementation occurs after morning therapeutic meals).
Arm Title
Intensive Multidisciplinary Intervention (Standard Care) + Hunger provocation (Rapid Tube Wean)
Arm Type
Experimental
Arm Description
Children with a history of chronic food refusal will be randomized to receive the experimental arm that combines standard care with rapid tube wean. All schedules and documents will be updated accordingly. After the 50% tube wean cut, the dietitian will use regular tube wean sheet to provide credit for oral intake for remainder of admission.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of Care
Other Intervention Name(s)
Standard of Care, Nutrition
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaning
Other Intervention Name(s)
Intervention Group, Rapid Tube Weaning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Percentage of oral intake
Description
The percent oral intake will be calculated by dividing calories consumed during therapeutic meals by the daily calorie target.
Time Frame
Up to 12 months
Title
Percent of patients achieving full wean and time to full wean
Description
% of participants reaching 100% of their caloric needs by mouth
Time Frame
Measured in days with a time frame of up to 12 months
Secondary Outcome Measure Information:
Title
Change in weight and BMI
Description
Weight will be measured in kilograms (Kg) on a digital scale; height measured in cm; BMI calculated from weight and height into kg/m2, z-score, and percentile
Time Frame
Up to 12 months
Title
Mealtime performance.
Description
Bite acceptance, rapid swallowing, and inappropriate mealtime behavior
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Volket, PhD, BCBA-D
Organizational Affiliation
Emory -Children's Ped Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Advanced Pediatrics
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Marcus Autism Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to deidentified research data.
IPD Sharing Time Frame
Immediately after publication.
IPD Sharing Access Criteria
The researchers will share the data with anyone who wishes to access the data for any purpose. Proposals should be addressed to Dr. Volkert. To gain access, data requestors will need to sign a data access agreement. Data will available for 5 years.

Learn more about this trial

Evaluating Hunger Manipulation During Feeding Intervention

We'll reach out to this number within 24 hrs