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Quality of Life in Food Allergic Families

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ClinicalTrials.gov Identifier: NCT01054950
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : June 30, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Food Allergy Behavioral: Counseling Behavioral: Placebo phone call

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Quality of Life in Food Allergic Families
Study Start Date : January 2010
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Education and counseling
Phone calls using behavioral techniques
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.
Placebo Comparator: Control
Single phone call
Behavioral: Placebo phone call
Phone call w/ no behavioral counseling

Outcome Measures

Primary Outcome Measures :
  1. Difference in validated quality of life survey [ Time Frame: twelve months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Contacts and Locations

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): NCT01054950

United States, Michigan
University of Michigan Allergy and Immunology Clinic
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Study Director: Alan Baptist, M.D University of Michigan Allergy and Immunology Clinic
More Information

Responsible Party: Alan Baptist, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT01054950     History of Changes
Other Study ID Numbers: HUM 33980
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases