Weighted Blanket to Treat Anxiety Related to Trying New Foods the Pediatric Population (NCT06420232) | Clinical Trial Compass
TerminatedNot Applicable
Weighted Blanket to Treat Anxiety Related to Trying New Foods the Pediatric Population
Stopped: challenges with recruitment and attrition, and PI graduated from UTMB PPOTD program
United States6 participantsStarted 2024-06-01
Plain-language summary
This small experimental pilot study addresses the knowledge gap related to the use of weighted blankets for children with anxiety related to food and eating.
Who can participate
Age range
8 Years – 12 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
. Subject and guardian has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
. Subject has identified feeding challenges
. Subject has anxiety related to food as reported by caregiver
. Subject is between the ages of 8-12
. Subject has good reading abilities
. Subject weighs 30 pounds or more
Exclusion criteria
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
Food Neophobia Scale for Children Questionnaire
Timeframe: Baseline, prior to treatment and post treatment
2
State-Trait Anxiety Inventory for Children (STAIC) Median T-Score
Timeframe: Prior and post treatment, up to 2 months
3
Average Number of New Foods
Timeframe: Control Period (1 month) and Treatment Period (1 month)
Trial details
NCT IDNCT06420232
SponsorThe University of Texas Medical Branch, Galveston
. Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation due to the inability to remove the blanket safely. Examples of diagnoses that would exclude a participant include spinal cord injury, cerebral palsy, and muscular dystrophy.
. Concurrent participation on another research study
. Participants outside of the ages 8-12
. Participants refuse to use the weighted blanket
. If the use of a weighted blanket is contraindicated for any reason
. Participants lacking the reading ability to complete a questionnaire
. Participants who weigh under 30 pounds per parent report and cannot use a commercially available weighted blanket as the minimum weight of a weighted blanket is 3 pounds will be excluded but this exclusion is unlikely due to the inclusion age range