Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies

NCT06525818 | Recruiting

• 1 other identifier: IRB23-1967
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this proposal is to test an interdisciplinary intervention to support the transition to oral feeding for children with feeding tubes and tracheostomies. The investigators' model which combines in-home clinical assessments with virtual therapies may maximize the impact of expert interventionists. The investigators' central hypothesis is that children with feeding tubes and tracheostomies will have greater success than a control group when enrolled in a hybrid in-person/virtual intervention including: (1) a coordinated feeding team with an occupational therapist, speech/language pathologist, and registered dietitian; (2) family liaison study coordinators who are poised to support the family through personal experience; (3) a project leader who is a Developmental Behavioral Pediatrician with expertise in children with tracheostomies. The overall objective of this proposal is to test this intervention to increase oral feeding in children with feeding tubes and tracheostomies. To pursue this objective, the investigators propose the following aims: Specific Aim 1: Children enrolled in the intervention group will have improved caregiver self-efficacy and reduced worry related to feeding as determined by The Feeding and Swallowing Impact Survey at the end of a 1-year intervention. Specific Aim 2: Children enrolled in the intervention group will have increased oral vs. tube-fed calories and reduced dependence on feeding tubes as determined by detailed dietary histories and The Children's Eating and Drinking Activity Scale (CEDAS) at the end of a 1-year intervention. The investigators' intervention will determine if a tertiary center of expertise can use a combination of home assessments and virtual interventions to address critical feeding needs for children with tracheostomies. Future clinicians could refer patients to the investigators' center instead of relying on community therapists, who rarely exist. The weekly feeding group sessions as well as the administration of the therapies in a virtual format are research-related. While the therapy techniques implemented during the study are standard of care and within the practice parameters of the practitioners involved, the use of them in a virtual format are novel and should be considered research-related.

Conditions

Feeding Tube; Children With Medical Complexity; Tracheostomy; Feeding Disorder, Infancy or Early Childhood

Outcome Measures

Primary Outcomes (1)

• Change in percentage of oral calories

  Oral calories will be calculated by determining how many calories are taken by mouth as a percentage of total (gastrostomy tube plus oral calorie intake).

  Baseline, 3 month, 6 month and exit at 1 year

Secondary Outcomes (3)

• Change in Oral Feeding

  Baseline, 3 month, 6 month and exit at 1 year

• Increased frequency of feeding trials

  Baseline, 3 month, 6 month and exit at 1 year

• Caregiver self-efficacy

  Baseline, 3 month, 6 month and exit at 1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

All participants in the intervention group will be invited to weekly virtual group therapy mealtime sessions with the Speech-Language Pathologist and other participants in the intervention group. Additionally, families will engage in virtual therapy sessions at least biweekly focused on individualized goals informed by the expertise of the study team and published expert programs. Individualized programs will include virtual sessions with the occupational therapist, speech therapist, or combined therapies. The team will consult with the registered dietitian and Developmental and Behavioral Pediatrician as needed.

Other: Tube weaning therapy intervention; Other: Feeding Group

Control group

OTHER

All participants in the control group will be invited to a weekly virtual group therapy mealtime session with other enrolled control group participants and a speech therapist who is not involved with the intervention. During this informal session, families will have the opportunity to meet other children with feeding tubes and their parents. The investigators will assess level of engagement (frequency of participation) and parental experience at interval assessments. Therapies research participants are already receiving or who begin to receive during the study period (early intervention community therapies, center-based therapies) will not be stopped during this intervention. Data will be collected on the frequency of these standard of care therapies. The assessments used for the control group will be the same assessments as the intervention group and will include the Speech Therapy Assessment; Occupational Therapy Assessment; and Pediatric Eating Assessment Toll.

Other: Feeding Group

Interventions

Tube weaning therapy intervention OTHER

Participants in the intervention group will be invited to weekly virtual group therapy mealtime sessions with the Speech-Language Pathologist and other participants in the intervention group. Additionally, families will engage in individual virtual therapy sessions at least biweekly focused on individualized goals informed by the expertise of the study team and published expert programs. Therapies intervention group participants are already receiving or who begin to receive during the study period will not be stopped during this intervention. The Speech Therapist and Occupational Therapist will be utilized as needed for the child's individualized care plan. They will consult with the registered dietitian and Developmental and Behavioral Pediatrician as needed.

Intervention group

Feeding Group OTHER

All participants in the control group will be invited to a weekly virtual group therapy mealtime session with other enrolled control group participants and a speech therapist who is not involved with the intervention. During this informal session, families will have the opportunity to meet other children with feeding tubes and their parents. The investigators will assess level of engagement (frequency of participation) and parental experience at interval assessments. Therapies research participants are already receiving or who begin to receive during the study period (early intervention community therapies, center-based therapies) will not be stopped during this intervention. Data will be collected on the frequency of these standard of care therapies. The assessments used for the control group will be the same assessments as the intervention group and will include the Speech Therapy Assessment; Occupational Therapy Assessment; and Pediatric Eating Assessment Toll.

Control group; Intervention group

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Under 3 years of age
• Reside at a family home
• Have a gastrostomy feeding tube
• Have a tracheostomy
• Live within a 1-hour radius of the University of Chicago

You may not qualify if:

• Wards of the state

Sponsors & Collaborators

• University of Chicago: lead
• The Gerber Foundation: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Sarah Sobotka, MD, MSCP

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Lynch, MPH

CONTACT

7737026461; elynch1@bsd.uchicago.edu

Sarah Sobotka, MD, MSCP

CONTACT

7737021187; ssobotka@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 29, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): July 7, 2027
• Study Completion (Estimated): July 7, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)