Anxiety State, Avoidant Restrictive Food Intake Disorder, Food Neophobia, Picky Eating
Conditions
Keywords
weighted blanket, food avoidance, picky eater, state anxiety, anxiety related to food, children
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.
Interventions
DEVICEweighted blanket
Blanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
usual care waitlist control period followed by one month intervention
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food Neophobia Scale for Children Questionnaire | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Weighted Blanket |
|---|---|
| Age, Categorical <=18 years | 6 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
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.
Time frame: Control Period (1 month) and Treatment Period (1 month)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weighted Blanket | Average Number of New Foods | Control Period | 7 number of foods tried | Standard Error 2.645751 |
| Weighted Blanket | Average Number of New Foods | Treatment Period | 6 number of foods tried | Standard Error 2 |
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).
Time frame: Baseline, prior to treatment and post treatment
Population: One participant did not complete the FNSC questionnaire at post-treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weighted Blanket | Food Neophobia Scale for Children Questionnaire | Prior Treatment without the blanket | 67 score on a scale | Standard Error 1.414214 |
| Weighted Blanket | Food Neophobia Scale for Children Questionnaire | Baseline | 67.5 score on a scale | Standard Error 2.12132 |
| Weighted Blanket | Food Neophobia Scale for Children Questionnaire | Post Treatment with the blanket | 65 score on a scale | Standard Error 1.414214 |
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.
Time frame: Prior and post treatment, up to 2 months
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Weighted Blanket | State-Trait Anxiety Inventory for Children (STAIC) Median T-Score | Prior to Treatment | 57 T-score | Standard Error 34.69577 |
| Weighted Blanket | State-Trait Anxiety Inventory for Children (STAIC) Median T-Score | Post Treatment | 54.5 T-score | Standard Error 34.63697 |