Evaluating Hunger Manipulation During Feeding Intervention

NCT05053438 | Completed DMC

• 1 other identifier: STUDY00002492
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 12 months

• Percent of patients achieving full wean and time to full wean

  % of participants reaching 100% of their caloric needs by mouth

  Measured in days with a time frame of up to 12 months

Secondary Outcomes (2)

• Change in weight and BMI

  Up to 12 months

• Mealtime performance.

  Up to 12 months

Study Arms (2)

Intensive Multidisciplinary Intervention (Standard Care)

ACTIVE COMPARATOR

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).

Behavioral: Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of Care

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

EXPERIMENTAL

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.

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

Interventions

Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of Care BEHAVIORAL

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.

Also known as: Standard of Care, Nutrition

Intensive Multidisciplinary Intervention (Standard Care)

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

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.

Also known as: Intervention Group, Rapid Tube Weaning

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

Eligibility Criteria

• Age: 18 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (2)

Center for Advanced Pediatrics

Atlanta, Georgia, 30329, United States

Location

Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Avoidant Restrictive Food Intake Disorder

Interventions

Standard of Care; Nutritional Status

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Valerie Volket, PhD, BCBA-D

  Emory -Children's Ped Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The allocation pattern is concealed to the investigators and therapists providing intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 22, 2021
• Study Start: July 1, 2021
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately after publication.
• 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.

Locations

US (2)