Food AllergyNCT01054950
Quality of Life in Food Allergic Families
A study testing Counseling in people with Food Allergy, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- What is being tested?
- Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- IgE mediated food allergy
- Ages 0-17
- Willing to participate
Who cannot join
- Food sensitivities
- Unable to understand or read survey
- Unable to be available for follow up survey and nurse phone calls.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Allergy and Immunology Clinic
Ann Arbor, Michigan, 48106
About this study
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.
Read the 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.
- Conditions
- Food Allergy
- Being tested
- Counseling, Placebo phone call
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
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 phone callBehavioural
Phone call w/ no behavioral counseling
| Study group | Role | What they receive |
|---|---|---|
| Education and counseling | Experimental | Phone calls using behavioral techniques Receives: Behavioral: Counseling |
| Control | Placebo comparator | Single phone call Receives: Behavioral: Placebo phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in validated quality of life survey
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Baptist, University of Michigan
- Investigators
- Alan Baptist, M.D, Study director, University of Michigan Allergy and Immunology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054950
- Sponsor's protocol ID
- HUM 33980
- Status last verified
- Jun 2016
- First submitted
- 21 Jan 2010
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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. No abstract available.
PubMed 22541244
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Food Allergic Families
- ClinicalTrials.gov ID
- NCT01054950
- Acronym / sponsor ID
- HUM 33980
- Conditions
- Food Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education and counseling | Experimental | Behavioral: CounselingPhone calls using behavioral techniques |
| Control | Placebo comparator | Behavioral: Placebo phone callSingle phone call |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- IgE mediated food allergy
- Ages 0-17
- Willing to participate
Key exclusion criteria (3 listed)
- Food sensitivities
- Unable to understand or read survey
- Unable to be available for follow up survey and nurse phone calls.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingOur food allergy nurse will contact our intervention group and discuss any questions or concerns they may have regarding their child's food allergy. | Behavioural | Education and counseling |
| Placebo phone callPhone call w/ no behavioral counseling | Behavioural | Control |
Primary outcome
Difference in validated quality of life survey
Time frame: twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Results publication: PubMed 22541244Baptist 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. No abstract available.
Related trials for Food Allergy
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Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
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Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
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Allergy, Food Allergies
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Baptist, M.D study director
University of Michigan Allergy and Immunology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling in people with Food Allergy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in validated quality of life survey (time frame: twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01054950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.