Actively Recruiting

Phase Not Applicable
Age: 0 - 3Years
All Genders
ID06525818

Let's E.A.T.! Eating With Assistive Technology: Supporting Children With Feeding Tubes and Tracheostomies Through Virtual and In-Home Therapies

Led by University of Chicago · Updated on 2025-08-12

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Chicago

Lead Sponsor

T

The Gerber Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial is studying an interdisciplinary approach to help children under 3 years old with feeding tubes and tracheostomies transition to oral feeding. The study evaluates whether combining in-home clinical assessments with virtual therapies by a specialized team can improve feeding outcomes. The goal is to increase oral feeding and reduce dependence on feeding tubes while supporting caregivers' confidence and reducing their worry about feeding. Participants are randomly assigned to either an intervention group or a control group. The intervention group receives weekly virtual group mealtime sessions plus biweekly individualized virtual therapies from a team including occupational therapists, speech-language pathologists, registered dietitians, and a developmental behavioral pediatrician. The control group attends weekly virtual group mealtime sessions only. Both groups continue any existing standard care therapies. The study includes initial in-home assessments, ongoing virtual therapy sessions, and a final home visit after one year. Families will participate in enrollment via video conferencing, complete surveys, and take part in scheduled virtual therapy and group sessions over one year. Assessments of feeding, oral intake, caregiver confidence, and dietary history occur at baseline, 3, 6, 9 months, and at the final exit visit after 12 months. Researchers monitor changes in oral calorie intake, feeding frequency, and caregiver self-efficacy. Safety and progress are tracked through regular surveys and home visits during the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 3Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Wards of the state

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (virtual via Zoom)

Initial Assessment

Duration - 1 day

Participants have an interdisciplinary team visit at home for comprehensive feeding assessments and dietary history. This includes physical measurements and evaluation of feeding abilities.

1 in-person home visit

Treatment

Duration - 12 months

Participants engage in weekly virtual group mealtime sessions. Intervention group participants additionally receive individualized virtual therapy sessions at least biweekly with specialists, plus consultations as needed.

Weekly virtual group sessions for all participants; biweekly individual virtual therapy sessions for intervention group

Follow-up

Duration - 12 months total with periodic assessments

Participants complete virtual assessments at 3, 6, and 9 months. At 12 months, participants have a final exit home visit with repeated assessments and surveys.

Virtual assessments at 3, 6, and 9 months; 1 in-person exit home visit at 12 months

Trial Site Locations

Total: 1 location

1

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

E

Emma Lynch, MPH

S

Sarah Sobotka, MD, MSCP

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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