## Protocol Section
### Identification Module
**NCT ID:** NCT06420232

**Acronym:** Food Anxiety

**Brief Title:** Weighted Blanket to Treat Anxiety Related to Trying New Foods the Pediatric Population

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

#### Organization Study ID Info
**ID:** 23-0342
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Medical Branch, Galveston
### Status Module
#### Completion Date
**Date:** 2026-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Texas Medical Branch, Galveston

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** usual care waitlist control period followed by one month intervention

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 12

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: weighted blanket

**Label:** Weighted Blanket

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Weighted Blanket

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

**Name:** weighted blanket

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Food Neophobia Scale for Children (FNSC) questionnaire

**Time Frame:** Baseline, prior and post treatment, up to 2 months

**Description:** 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.

**Measure:** State-Trait Anxiety Inventory for Children (STAIC)

**Time Frame:** Baseline, prior and post treatment, up to 2 months

**Description:** Initial list of foods tolerated and subsequent foods added during the study

**Measure:** Food Logs

**Time Frame:** Baseline, prior and post treatment, up to 2 months

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 12 Years

**Minimum Age:** 8 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clhilton@utmb.edu

**Name:** Claudia A Hilton, PhD

**Phone:** 3143415161

**Role:** CONTACT

**Contact 2:**

**Email:** hcelkis11@gmail.com

**Name:** Heather D Celkis, BS

**Phone:** 5129684297

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Austin

**Contacts:**

***Contact 1:***

- **Email:** h_celkis@capitalareaspeech.com

- **Name:** Heather D Celkis, BS

- **Phone:** 512-968-4297

- **Role:** CONTACT

**Country:** United States

**Facility:** Capital Area Speech & Occupational Therapy

**State:** Texas

**Status:** RECRUITING

**Zip:** 78759

### IPD Sharing Statement Module

**Access Criteria:** per request

**Description:** upon request, deidentified data will be shared

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** May 2025 for 5 years

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

- ID: D000001068

- Term: Feeding and Eating Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M5114

- Name: Body Weight

- Relevance: HIGH

- As Found: Weighted

- ID: M2123

- Name: Avoidant Restrictive Food Intake Disorder

- Relevance: HIGH

- As Found: Avoidant Restrictive Food Intake Disorder

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4380

- Name: Feeding and Eating Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001835

- Term: Body Weight

- ID: D000001008

- Term: Anxiety Disorders

- ID: D000080146

- Term: Avoidant Restrictive Food Intake Disorder

### Misc Info Module

- Version Holder: 2024-05-31
