Weighted Blanket for Picky Eating Anxiety

(Food Anxiety Trial)

Overseen By Heather D Celkis, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Spinal cord injury, Cerebral palsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether a weighted blanket can help reduce anxiety around food and eating in children. The focus is on kids who experience anxiety specifically linked to eating and face noticeable challenges with food. Children between 8 and 12 years old, who have good reading skills and weigh at least 30 pounds, may be suitable for this trial. The trial will assess if the calming effect of a weighted blanket can improve eating experiences for these children. As an unphased trial, this study offers a unique opportunity for children to potentially benefit from a non-invasive approach to easing eating-related anxiety.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this weighted blanket is safe for children with anxiety related to food and eating?

Research shows that weighted blankets are generally safe for children. A review of studies found no safety issues among participants using weighted blankets, and no serious side effects were reported. Another review also identified no serious problems with these blankets. Often used to help reduce anxiety, they seem to make many people feel calmer. The evidence suggests that using a weighted blanket is a low-risk way to manage anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for picky eating anxiety in children involve behavioral therapies or medications aimed at reducing anxiety. However, the weighted blanket offers a unique approach by utilizing deep pressure stimulation to provide a calming effect. Researchers are excited about this treatment because it is non-invasive and does not rely on pharmaceuticals, which can have side effects. Additionally, the comforting weight of the blanket can be used easily at home, offering a practical and immediate soothing tool for children experiencing anxiety around meals.

What evidence suggests that a weighted blanket is effective for anxiety related to picky eating?

Research has shown that weighted blankets can help reduce anxiety in various situations. One review found that 60% of people felt less anxious when using weighted blankets. Another study reported that 63% of people experienced lower anxiety levels after using one. Additionally, weighted blankets can improve sleep quality and reduce negative feelings, benefiting those with anxiety. This trial will investigate whether using a weighted blanket can help with anxiety related to picky eating. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children who are anxious about trying new foods, which may include conditions like Avoidant/Restrictive Food Intake Disorder or being extremely picky eaters. Specific eligibility criteria were not provided.

Inclusion Criteria

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

My caregiver reports that I have anxiety related to food.

Exclusion Criteria

If the use of a weighted blanket is contraindicated for any reason

Concurrent participation on another research study

Participants lacking the reading ability to complete a questionnaire

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Parents complete a questionnaire and list foods the child eats before the study begins

2 weeks

Treatment

Children use a weighted blanket for 5 to 15 minutes prior to at least 3 meals a week for one month

4 weeks

Weekly check-ins (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Weighted Blanket

Trial Overview The study is testing whether using a weighted blanket can help reduce anxiety in children when they face new foods. It's an initial small-scale experiment to explore this potential treatment method.

How Is the Trial Designed?

Group I: Weighted Blanket Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Published Research Related to This Trial

In two studies involving 762 participants, attachment anxiety was found to directly predict night eating syndrome (NES) scores, with disinhibited eating behaviors acting as a mediator in this relationship.

The research suggests that addressing attachment anxiety could be a potential intervention target for NES, highlighting the importance of emotional management in eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adult attachment anxiety is associated with night eating syndrome in UK and US-based samples: Two cross-sectional studies. Wilkinson, LL., Rowe, AC., Douglas, T., et al.[2022]

In a study involving 37 women with a history of anorexia nervosa, rumination exercises increased analytical self-focus, indicating that individuals with anorexia may struggle with self-reflection during meal times.

Mindful breathing was found to promote greater experiential self-focus compared to distraction, but it was challenging to shift participants away from rumination, suggesting that more targeted interventions may be needed in treatment for anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rumination and modes of processing around meal times in women with anorexia nervosa: qualitative and quantitative results from a pilot study. Cowdrey, FA., Stewart, A., Roberts, J., et al.[2013]

Mindfulness approaches show promise in treating eating disorders in adolescents, with 13 out of 15 studies indicating positive effects on reducing eating disorder symptoms and improving healthy eating behaviors.

Despite these encouraging results, the research is still in its early stages, highlighting the need for more rigorous studies to establish the acceptability and efficacy of mindfulness interventions for adolescents with eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Mindfulness-Related Interventions to Modify Eating Behaviors in Adolescents. Omiwole, M., Richardson, C., Huniewicz, P., et al.[2020]

Augmented reality (AR) food stimuli can evoke emotional responses similar to real food, indicating its potential as a tool for treating binge eating behaviors.

Obese individuals exhibited lower happiness and different emotional responses to food compared to control participants, suggesting that AR could help address these emotional differences in therapeutic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing Augmented Reality for Cue Exposure in Obese Patients: An Exploratory Study. Pallavicini, F., Serino, S., Cipresso, P., et al.[2018]

In a randomized controlled trial involving 23 patients with anorexia nervosa (AN) or avoidant-restrictive food intake disorder (ARFID), the use of weighted blankets showed a greater decrease in anxiety levels compared to usual care, although the results were not statistically significant.

Weighted blankets may serve as a beneficial non-pharmacological intervention for reducing anxiety in patients with AN and ARFID, adding to the multidisciplinary treatment options available for these eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Impact of Weighted Blankets on Anxiety Among Patients With Anorexia Nervosa and Avoidant- Restrictive Food Intake Disorder: A Randomized Controlled Trial. Ohene, R., Logan, C., Loresto, F., et al.[2023]

In a study involving 64 females with anorexia nervosa, progressive muscle relaxation (PMR), guided imagery (GI), and self-directed relaxation (SR) significantly reduced post-meal anxiety compared to a control group, highlighting their efficacy in managing anxiety during re-nutrition.

Participants reported high enjoyment and acceptability of the relaxation techniques, suggesting they could be beneficial tools for patients undergoing treatment for anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory study to decrease postprandial anxiety: Just relax! Shapiro, JR., Pisetsky, EM., Crenshaw, W., et al.[2008]

The Fear of Food Measure (FOFM) was developed and validated across four studies, demonstrating its effectiveness in assessing anxiety and avoidance behaviors related to eating in individuals with anorexia nervosa (AN).

In a clinical sample, the FOFM showed that anxiety about eating predicted food intake and decreased significantly after a four-session exposure therapy, indicating its potential utility in monitoring treatment progress and targeting specific behaviors in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fear of food measure: a novel measure for use in exposure therapy for eating disorders. Levinson, CA., Byrne, M.[2018]

Citations

1. research.aota.org research.aota.org/ajot/article/74/2/7402205010p1/6662/Weighted-Blanket-Use-A-Systematic-Review

Weighted Blanket Use: A Systematic Review Weighted blankets were shown to be safe for 100% of participants and effective at reducing anxiety for 60% of participants, as measured by the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36622934/

Assessing the Impact of Weighted Blankets on Anxiety ... Weighted blankets may be an effective tool for reducing anxiety among patients with AN or ARFID.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11056563/

The effect of weighted blankets on sleep and related disorders Most of the included studies showed that weighted blankets could effectively improve sleep quality and alleviate negative emotions and daytime symptoms.

4. researchgate.net researchgate.net/publication/366982043_Assessing_the_Impact_of_Weighted_Blankets_on_Anxiety_Among_Patients_With_Anorexia_Nervosa_and_Avoidant-_Restrictive_Food_Intake_Disorder_A_Randomized_Controlled_Trial

Assessing the Impact of Weighted Blankets on Anxiety ... Data obtained on effectiveness reveal 33% demonstrated lowering in EDA when using the weighted blanket, 63% reported lower anxiety after use, and 78% preferred ...

5. juniperpublishers.com juniperpublishers.com/pbsij/PBSIJ.MS.ID.556096.php

Effectiveness of Anxiety Reduction in Adults by Weighted ... The results suggest that some anxiety relief can occur after a single session. Prolonged use over days or weeks is also shown to be effective.

6. ctv.veeva.com ctv.veeva.com/study/weighted-blanket-to-treat-anxiety-related-to-trying-new-foods-the-pediatric-population

Weighted Blanket to Treat Anxiety Related to Trying New ... The purpose of the study is to research if weighted blankets might help children with anxiety related to food tolerate new foods better. The ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39447684/

Safety and effectiveness of weighted blankets for symptom ... No serious adverse events were reported with the application of weighted blankets. The meta-analysis of five studies revealed that the use of weighted blankets ...