Evaluating Hunger Manipulation During Feeding Intervention
Completed · Not applicable
Conditions studied: Feeding Disorders, Feeding and Eating Disorders, Avoidant/Restrictive Food Intake Disorder
In brief
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.
Key facts
- Study ID
- NCT05053438
- Run by
- Emory University
- People needed
- 16
- Starts
- 2021-07-01
- Expected to finish
- 2023-10-18
- Last updated by the study team
- 2023-11-28
Who can join
Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Center for Advanced Pediatrics — Atlanta, Georgia, United States
- Marcus Autism Center — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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