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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Weighted Blanket for Picky Eating Anxiety?

Research shows that weighted blankets can help reduce anxiety in patients with anorexia nervosa and avoidant-restrictive food intake disorder, which are conditions related to eating and anxiety. This suggests that weighted blankets might also help with anxiety related to picky eating. ^{1 2 3 4 5}

How is the weighted blanket treatment different from other treatments for picky eating anxiety?

The weighted blanket treatment is unique because it uses a physical object to provide a calming effect, which can help reduce anxiety related to picky eating. Unlike medications or traditional therapies, weighted blankets offer a non-invasive, sensory-based approach that has been used to alleviate anxiety in other conditions like anorexia nervosa and avoidant-restrictive food intake disorder. ^{1 2 3 6 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The fear of food measure: a novel measure for use in exposure therapy for eating disorders. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Exploratory study to decrease postprandial anxiety: Just relax! [2008]

4. England 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. [2013]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Review of Mindfulness-Related Interventions to Modify Eating Behaviors in Adolescents. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Testing Augmented Reality for Cue Exposure in Obese Patients: An Exploratory Study. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Adult attachment anxiety is associated with night eating syndrome in UK and US-based samples: Two cross-sectional studies. [2022]