Quality of Life in Food Allergic Families

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01054950
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : June 30, 2016
Information provided by (Responsible Party):
Alan Baptist, University of Michigan

January 21, 2010
January 22, 2010
June 30, 2016
January 2010
August 2010   (Final data collection date for primary outcome measure)
Difference in validated quality of life survey [ Time Frame: twelve months ]
Same as current
Complete list of historical versions of study NCT01054950 on Archive Site
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Quality of Life in Food Allergic Families
Quality of Life in Food Allergic Families
Food allergies are becoming more prevalent with more children being diagnosed with food allergies each year. Food allergies place a tremendous burden not just on the patient but on his/her family as well. In an attempt to provide better care to the investigators patients, the investigators would like to determine if regular contact with our food allergy nurse has a positive effect on a family's perceived quality of life.
We intend to show a difference between the intervention group, who will receive a food allergy packet, along with three follow up phone calls from our trained allergy nurse, and the control group, will be given the food allergy packet only. We expect the intervention group to score higher on the quality of life survey, showing that the support and education of our allergy nurse has a positive effect on quality of life of our patients and their families.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Food Allergy
  • Behavioral: Counseling
    Our food allergy nurse will contact our intervention group and discuss any questions or concerns they may have regarding their child's food allergy.
  • Behavioral: Placebo phone call
    Phone call w/ no behavioral counseling
  • Experimental: Education and counseling
    Phone calls using behavioral techniques
    Intervention: Behavioral: Counseling
  • Placebo Comparator: Control
    Single phone call
    Intervention: Behavioral: Placebo phone call
Baptist AP, Dever SI, Greenhawt MJ, Polmear-Swendris N, McMorris MS, Clark NM. A self-regulation intervention can improve quality of life for families with food allergy. J Allergy Clin Immunol. 2012 Jul;130(1):263-5.e6. doi: 10.1016/j.jaci.2012.03.029. Epub 2012 Apr 26.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • IgE mediated food allergy
  • Ages 0-17
  • Willing to participate

Exclusion Criteria:

  • Food sensitivities
  • Unable to understand or read survey
  • Unable to be available for follow up survey and nurse phone calls.
Sexes Eligible for Study: All
up to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
HUM 33980
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Alan Baptist, University of Michigan
University of Michigan
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Study Director: Alan Baptist, M.D University of Michigan Allergy and Immunology Clinic
University of Michigan
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP