Weighted Blanket to Treat Anxiety Related to Trying New Foods the Pediatric Population

NCT06420232 | Terminated Results FDA Device

• 1 other identifier: 23-0342
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Neophobia; Picky Eating; Avoidant Restrictive Food Intake Disorder; Anxiety State

Keywords

weighted blanket; food avoidance; picky eater; state anxiety; anxiety related to food; children

Outcome Measures

Primary Outcomes (3)

• Food Neophobia Scale for Children Questionnaire

  The Food Neophobia Scale for Children is a 10-item Likert scale questionnaire that parents complete. The responses to the questions on the Food Neophobia Scale for Children ranged from one (Strongly Agree) to seven (Strongly Disagree). The value of each response could be worth 7 points, depending on the responses. The caregivers completed the Food Neophobia Scale for Children questionnaire at baseline, following the usual care period, and after the intervention period. Higher total scores indicate higher levels of food neophobia. The total score range was 10 (lowest) to 70 (highest).

  Baseline, prior to treatment and post treatment

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

  The STAI-C Anxiety Scale asks for ratings of agreement on a 3-point scale using the stem "I feel…" for 20 items both indicative of the presence of anxiety (e.g., 1= not upset; 2= upset; 3= very upset) and reverse-worded (e.g., 1= very calm; 2= calm; 3= not calm) items. The participants completed the STAIC S-Anxiety scale three times per week during the usual care and treatment period. Higher T-scores indicate higher anxiety. The mean of the normalized T-score was 50, and the standard deviation was 10. No established clinical thresholds are defined for this measure.

  Prior and post treatment, up to 2 months

• Average Number of New Foods

  The average number of foods tried during the control period will be compared to baseline and the average number of new foods tried during the control period will be compared to the average number of new foods tried in the treatment period to understand if more foods were tried when using the weighted blanket.

  Control Period (1 month) and Treatment Period (1 month)

Study Arms (1)

Weighted Blanket

EXPERIMENTAL

Device: weighted blanket

Interventions

weighted blanket DEVICE

Blanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes

Weighted Blanket

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Capital Area Speech & Occupational Therapy

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder; Food Fussiness; Anxiety Disorders

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Feeding Behavior; Behavior

Limitations and Caveats

Challenges with recruitment and attrition, and PI graduated from the UTMB PPOTD program.

Results Point of Contact

• Title: Heather Celkis, OTR, PPOTD
• Organization: University of Texas Medical Branch, Galveston

hdcelkis@UTMB.EDU

409-

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: usual care waitlist control period followed by one month intervention

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 17, 2024
• Study Start: June 1, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: May 2025 for 5 years
• Access Criteria: per request

Locations

US (1)