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Intensive Multidisciplinary Feeding Intervention (IMFI) for Eating Disorders
N/A
Waitlist Available
Led By Valerie Volket, PhD, BCBA-D
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial will study if it's feasible to quickly wean people with ARFID off of enteral feedings, and if doing so has any effect when used as part of an intensive multidisciplinary feeding intervention.
Eligible Conditions
- Eating Disorders
- Feeding Disorders
- Avoidant Restrictive Food Intake Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Percentage of oral intake
Percent of patients achieving full wean and time to full wean
Secondary outcome measures
Change in weight and BMI
Mealtime performance.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intensive Multidisciplinary Intervention (Standard Care) + Hunger provocation (Rapid Tube Wean)Experimental Treatment1 Intervention
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.
Group II: Intensive Multidisciplinary Intervention (Standard Care)Active Control1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaning
2021
N/A
~20
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,557 Total Patients Enrolled
Children's Healthcare of AtlantaOTHER
165 Previous Clinical Trials
105,114 Total Patients Enrolled
Valerie Volket, PhD, BCBA-DPrincipal InvestigatorEmory -Children's Ped Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You weigh less than what is considered healthy for your height.You have severe malnutrition or have recently lost a significant amount of weight.People who have a condition where they avoid or restrict certain foods, but can still get at least 80% of their daily calories from normal meals.You have experience eating food by mouth before.You are able to swallow safely and without any problems.
Research Study Groups:
This trial has the following groups:- Group 1: Intensive Multidisciplinary Intervention (Standard Care)
- Group 2: Intensive Multidisciplinary Intervention (Standard Care) + Hunger provocation (Rapid Tube Wean)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots in the clinical trial for prospective participants?
"Affirmative. Clinicaltrials.gov displays that the trial, which was posted on July 1st 2021, is actively recruiting participants. 32 patients are needed to be enrolled from two different sites."
Answered by AI
Are elderly individuals being included in the trial's participant pool?
"This trial only allows for enrollment of participants between 18 months and 6 years old."
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Who is eligible to register for this clinical research?
"Eligible applicants must have been diagnosed with an eating disorder and be between 18 months and 6 years of age. This trial aims to recruit a total of 32 participants."
Answered by AI
What is the scope of research participants in this clinical trial?
"That is accurate. According to clinicaltrials.gov, this medical research project was initially listed on July 1st 2021 and the most recent changes were made September 15th 2022. Currently, there are spaces for 32 participants between 2 locations available in this study."
Answered by AI
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