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Behavioural Intervention
Weighted Blanket for Picky Eating Anxiety (Food Anxiety Trial)
N/A
Recruiting
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is between the ages of 8-12
Subject weighs 30 pounds or more
Must not have
Participants outside of the ages 8-12
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, prior and post treatment, up to 2 months
Awards & highlights
Summary
"This trial is looking at how weighted blankets can help children with anxiety about food and eating."
Who is the study for?
This trial is for children who are anxious about trying new foods, which may include conditions like Avoidant/Restrictive Food Intake Disorder or being extremely picky eaters. Specific eligibility criteria were not provided.
What is being tested?
The study is testing whether using a weighted blanket can help reduce anxiety in children when they face new foods. It's an initial small-scale experiment to explore this potential treatment method.
What are the potential side effects?
Since the intervention involves a non-medical device (weighted blanket), side effects might be minimal but could include discomfort due to weight, warmth, or issues with sleep if used improperly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 8 and 12 years old.
Select...
I weigh at least 30 pounds.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not between the ages of 8 and 12.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, prior and post treatment, up to 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, prior and post treatment, up to 2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Food Logs
Food Neophobia Scale for Children (FNSC) questionnaire
State-Trait Anxiety Inventory for Children (STAIC)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Weighted BlanketExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
weighted blanket
2020
N/A
~140
Find a Location
Who is running the clinical trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
249 Previous Clinical Trials
56,628 Total Patients Enrolled
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