Food NeophobiaFood AnxietyNCT06420232
Weighted Blanket to Treat Anxiety Related to Trying New Foods the Pediatric Population
A study testing weighted blanket in people with Food Neophobia and Picky Eating, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Neophobia, Picky Eating, Avoidant Restrictive Food Intake Disorder
- What is being tested?
- weighted blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Capital Area Speech & Occupational Therapy
Austin, Texas, 78759
About this study
Official title: 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.
Read the 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.
- Being tested
- weighted blanket
- Keywords
- weighted blanket, food avoidance, picky eater, state anxiety, anxiety related to food, children
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder, Food Fussiness, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weighted blanketDevice
Blanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Weighted Blanket | Experimental | Not described Receives: Device: weighted blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Control Period (1 month) and Treatment Period (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Jun 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Why it stopped: challenges with recruitment and attrition, and PI graduated from UTMB PPOTD program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Food NeophobiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- usual care waitlist control period followed by one month intervention
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420232
- Sponsor's protocol ID
- 23-0342
- Acronym
- Food Anxiety
- Status last verified
- Jul 2025
- First submitted
- 10 May 2024
- Last updated
- 5 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: upon request, deidentified data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Using a Weighted Blanket to Treat Anxiety Related to Trying New Foods in the Pediatric Population
- ClinicalTrials.gov ID
- NCT06420232
- Acronym / sponsor ID
- Food Anxiety / 23-0342
- Keywords
- weighted blanket, food avoidance, picky eater, state anxiety, anxiety related to food, children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: challenges with recruitment and attrition, and PI graduated from UTMB PPOTD program
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Posted 5 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- usual care waitlist control period followed by one month intervention
| Arm | Type | Receives |
|---|---|---|
| Weighted Blanket | Experimental | Device: weighted blanket |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weighted blanketBlanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes | Device | Weighted Blanket |
Primary outcome
Food Neophobia Scale for Children Questionnaire
Time frame: Baseline, prior to treatment and post treatment
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).
State-Trait Anxiety Inventory for Children (STAIC) Median T-Score
Time frame: Prior and post treatment, up to 2 months
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.
Average Number of New Foods
Time frame: Control Period (1 month) and Treatment Period (1 month)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. upon request, deidentified data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weighted blanket in people with Food Neophobia and Picky Eating, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Neophobia Scale for Children Questionnaire (time frame: Baseline, prior to treatment and post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.