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

Anxiety State Clinical Trial

— Food Anxiety  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06420232
• Other study ID #: 23-0342
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: April 2026

Study information

• Verified date: June 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: Claudia A Hilton, PhD
• Phone: 3143415161
• Email: clhilton[@]utmb.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: April 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Body Weight
• Food Neophobia

Intervention

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

Locations

Country	Name	City	State
United States	Capital Area Speech & Occupational Therapy	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food Neophobia Scale for Children (FNSC) questionnaire	The FNSC questionnaire is composed of ten questions, being answered by parents in a scale from one to seven, in which number one means "not at all" and seven means "extremely distant to the reality of my child.	Baseline, prior and post treatment, up to 2 months
Primary	State-Trait Anxiety Inventory for Children (STAIC)	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.	Baseline, prior and post treatment, up to 2 months
Primary	Food Logs	Initial list of foods tolerated and subsequent foods added during the study	Baseline, prior and post treatment, up to 2 months