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 range8 Years – 12 Years

SexALL

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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

✕. 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

What they're measuring

Food Neophobia Scale for Children Questionnaire

Timeframe: Baseline, prior to treatment and post treatment

State-Trait Anxiety Inventory for Children (STAIC) Median T-Score

Timeframe: Prior and post treatment, up to 2 months

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-20

Results submitted2025-05-12

View on ClinicalTrials.gov More Food Neophobia trials