Feeding and Eating Disorders Clinical Trial
Official title:
Evaluating Hunger Manipulation as an Adjunct to Behavioral Intervention During Intensive Multidisciplinary Feeding Intervention
Verified date | November 2023 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | October 18, 2023 |
Est. primary completion date | October 18, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Months to 6 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Center for Advanced Pediatrics | Atlanta | Georgia |
United States | Marcus Autism Center | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Children's Healthcare of Atlanta |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Change in weight and BMI | Weight will be measured in kilograms (Kg) on a digital scale; height measured in cm; BMI calculated from weight and height into kg/m2, z-score, and percentile | Up to 12 months | |
Secondary | Mealtime performance. | Bite acceptance, rapid swallowing, and inappropriate mealtime behavior | Up to 12 months |
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