Evaluating Hunger Manipulation During Feeding Intervention
United States16 participantsStarted 2021-07-01
Plain-language summary
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.
Who can participate
Age range
18 Months – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Percentage of oral intake
Timeframe: Up to 12 months
2
Percent of patients achieving full wean and time to full wean
Timeframe: Measured in days with a time frame of up to 12 months