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

Protocol for Using a Weighted Blanket to Treat Anxiety Related to Trying New Foods in the Pediatric Population

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.

Study Overview

• Status: Terminated
• Conditions: Anxiety State; Avoidant Restrictive Food Intake Disorder; Picky Eating; Food Neophobia
• Intervention / Treatment: Device: weighted blanket

Detailed Description

The purpose of the study is to research if weighted blankets might help children with anxiety related to food tolerate new foods better. The parent will be asked to complete a 10-question questionnaire and make a list of the foods the child eats on three occasions (before the study begins, after a control period and after the child uses the weighted blanket). The child will be asked to use a weighted blanket for 5 to 15 minutes prior to at least 3 meals a week for one month, and the child will be asked to complete a 20-question questionnaire taking about 5-12 minutes to complete asking about how they feel on days that they use the weighted blanket and one time a week during the month that they don't use the weighted blanket. The parent will be asked to report any new foods the child tries on the days that they do use the weighted blanket. The parent will be asked to keep the weighted blanket and supervise all use of the weighted blanket for safety. This study will take approximately 2 months total.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78759
      • Capital Area Speech & Occupational Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. Subject has identified feeding challenges
3. Subject has anxiety related to food as reported by caregiver
4. Subject is between the ages of 8-12
5. Subject has good reading abilities
6. Subject weighs 30 pounds or more

Exclusion Criteria:

1. 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.
2. Concurrent participation on another research study
3. Participants outside of the ages 8-12
4. Participants refuse to use the weighted blanket
5. If the use of a weighted blanket is contraindicated for any reason
6. Participants lacking the reading ability to complete a questionnaire
7. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weighted Blanket	Device: weighted blanket; Blanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: children; weighted blanket; state anxiety; food avoidance; picky eater; anxiety related to food
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Avoidant Restrictive Food Intake Disorder; Anxiety Disorders; Body Weight
• Other Study ID Numbers: 23-0342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: upon request, deidentified data will be shared
• IPD Sharing Time Frame: May 2025 for 5 years
• IPD Sharing Access Criteria: per request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No