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Assessing Risk of Food Insecurity Within Households of Children With Food Allergy

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ClinicalTrials.gov Identifier: NCT01897506
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Brief Summary:
Our central hypothesis is that dietary limitations introduced by food allergy will contribute to increased food insecurity in households with food allergic children when compared to food insecure households without food allergic children.

Condition or disease
Food Allergy Asthma Allergic Rhinitis Atopic Dermatitis Eosinophilic Esophagitis

Detailed Description:

Specific Aim 1 To describe food insecurity in families of the pediatric allergy population, specifically comparing the prevalence of food insecurity rates between households of food allergic patients and households of allergic patients without food allergy.

Specific Aim 2 To examine health literacy in parents of patients in the pediatric allergy population, comparing food insecure patients with and without food allergy to food secure patients with food allergy.

Specific Aim 3 To examine quality of life in food allergic patients' households using the food allergy impact scale, comparing food allergic patients' households with food insecurity to food allergic patients' households without food insecurity.


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Study Type : Observational
Actual Enrollment : 650 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessing Risk of Food Insecurity Within Households of Children With Food Allergy
Study Start Date : June 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Presence of food insecurity within an atopic population [ Time Frame: 1.25 years ]
    The primary outcome variable of interest is the presence of food insecurity (patients with Low Food Security or Very Low Food Security). A chi-square test of independence will be used to test the association between food insecurity and food allergy.


Secondary Outcome Measures :
  1. Health Literacy Rate [ Time Frame: 1.25 years ]
    A logistic regression analysis will be done to test the effect of food allergy and food insecurity on the health illiteracy rates after adjusting for confounding variables such as demographics. Appropriate contrasts for the interaction effect between food allergy and food insecurity will also be used to compare health literacy rates.


Other Outcome Measures:
  1. Quality of life of families with food allergic members [ Time Frame: 1.25 years ]
    The average quality of life score taken across all six items in the quality of life questionnaire will be the outcome variable of interest. The mean average quality of life score between the food secure households with food allergy and the food insecure households with food allergy will be compared between the two groups using an ANCOVA method.



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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Families with children who have allergy appointments at Arkansas Children's Hospital between 1-17 years of age. We will recruit 325 families with patients in the food allergy group and 325 families with patients in the without food allergy group.
Criteria

Inclusion Criteria:

  • Parents whose child has an allergy appointment with the Allergy and Immunology Department at Arkansas Children's Hospital between 1-17 years of age with allergic disease

Exclusion Criteria:

  • Parents whose child has an allergy appointment with the Allergy and Immunology Department at Arkansas Children's Hospital less than 1 years of age or 18 years of age and older will not be eligible to participate in this study. Children with immunodeficiency disease will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897506


Locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
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Principal Investigator: Stacie M Jones, MD University of Arkansas for Medical Sciences / Arkansas Children's Hospital

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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01897506     History of Changes
Other Study ID Numbers: 201920
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

Keywords provided by Arkansas Children's Hospital Research Institute:
Food insecurity
Health literacy
Quality of life

Additional relevant MeSH terms:
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Food Hypersensitivity
Dermatitis
Rhinitis
Hypersensitivity
Dermatitis, Atopic
Eczema
Rhinitis, Allergic
Esophagitis
Eosinophilic Esophagitis
Skin Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Immune System Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Respiratory Hypersensitivity
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases