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challenges with recruitment and attrition, and PI graduated from UTMB PPOTD program
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weighted Blanket | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Area Speech & Occupational Therapy | Austin | Texas | 78759 | United States |
upon request, deidentified data will be shared
May 2025 for 5 years
per request
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| ID | Title | Description |
|---|---|---|
| FG000 | Weighted Blanket | weighted blanket: Blanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Weighted Blanket | weighted blanket: Blanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | One participant did not complete the FNSC questionnaire at post-treatment. | Posted | Mean | Standard Error | score on a scale | Baseline, prior to treatment and post treatment |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Period | A blanket weighted with 10% or less of body weight is applied to a child prior to meals for a duration of no more than 15 minutes 3 times a week for a period of 1 month. |
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Challenges with recruitment and attrition, and PI graduated from the UTMB PPOTD program.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Celkis, OTR, PPOTD | University of Texas Medical Branch, Galveston | 409- | hdcelkis@UTMB.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2024 | Apr 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000080146 | Avoidant Restrictive Food Intake Disorder |
| D000081010 | Food Fussiness |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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usual care waitlist control period followed by one month intervention
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | 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. | Posted | Median | Standard Error | T-score | Prior and post treatment, up to 2 months |
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | number of foods tried | Control Period (1 month) and Treatment Period (1 month) |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Control Period | Occupational therapy services treatment as usual without use of a weighted blanket for a period of 1 month. | 0 | 3 | 0 | 3 | 0 | 3 |
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