Trial Outcomes & Findings for Weighted Blanket to Treat Anxiety Related to Trying New Foods the Pediatric Population (NCT NCT06420232)

NCT ID: NCT06420232

Last Updated: 2025-08-05

Results Overview

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).

Recruitment status

TERMINATED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Baseline, prior to treatment and post treatment

Results posted on

2025-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	6
Overall Study Control Period	6
Overall Study Treatment Period	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Weighted Blanket n=6 Participants weighted blanket: Blanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes
Age, Categorical <=18 years	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, prior to treatment and post treatment

Population: One participant did not complete the FNSC questionnaire at post-treatment.

Outcome measures

Outcome measures
Measure	Weighted Blanket n=2 Participants weighted blanket: Blanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes
Food Neophobia Scale for Children Questionnaire Baseline	67.5 score on a scale Standard Error 2.12132
Food Neophobia Scale for Children Questionnaire Prior Treatment without the blanket	67 score on a scale Standard Error 1.414214
Food Neophobia Scale for Children Questionnaire Post Treatment with the blanket	65 score on a scale Standard Error 1.414214

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weighted Blanket n=3 Participants weighted blanket: Blanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes
State-Trait Anxiety Inventory for Children (STAIC) Median T-Score Prior to Treatment	57 T-score Standard Error 34.69577
State-Trait Anxiety Inventory for Children (STAIC) Median T-Score Post Treatment	54.5 T-score Standard Error 34.63697

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weighted Blanket n=3 Participants weighted blanket: Blanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes
Average Number of New Foods Control Period	7 number of foods tried Standard Error 2.645751
Average Number of New Foods Treatment Period	6 number of foods tried Standard Error 2

Adverse Events

Treatment Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather Celkis, OTR, PPOTD

University of Texas Medical Branch, Galveston

Phone: 409-

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place