Food Allergy in ChildrenF3A-AppNCT05111938
Friends, Family & Food: Food Allergy App for Youth - II
A study testing Friends, Family, and Food App (F3A-App) in people with Food Allergy in Children, run by Rhode Island Hospital.
Trial summary
Objective: This Phase II STTR grant incorporated user feedback collected in an earlier development project to build interactive, web-based software that helps children with food allergies learn about their condition and gain self-management skills. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Food Allergy in Children
- What is being tested?
- Friends, Family, and Food App (F3A-App)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2016to 19 May 2017
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child must be 8-12
- child must have an active diagnosis of FA, confirmed by a physician
- child and parent must speak and read English
- child must have access to a computer with internet access
- child must have access to a smartphone or table
Who cannot join
- any chronic health condition requiring substantial dietary self-management (e.g., diabetes)
About this study
Official title: Friends, Family and Food: Interactive Virtual Environments for Children With Food Allergies - II
Objective: This Phase II STTR grant incorporated user feedback collected in an earlier development project to build interactive, web-based software that helps children with food allergies learn about their condition and gain self-management skills. This highly interactive game allows children to progress through virtual scenes to help them learn about food avoidance, symptom detection, and reaction management. In addition, this project built gaming complexity, with more levels and game options, of the two interactive games "Label Learning: Like it or Lose it!" and "Reaction Action!." Research Procedures: The researchers elicited input from 8 families of children (ages 8-12) with food allergies and their parents by presenting some of preliminary intervention materials (e.g., storyboards of a child in a family gathering involving food) in a focus group format. After that, up to 40 families of children with food allergies (ages 8-12) were recruited to participate in an "open trial". Families were asked to use the software for two weeks and provide feedback on the software. Up to 100 families of children with food allergies (ages 8-12) were then recruited to participate in a Randomized Clinical Trial (RCT) to assess the efficacy of the F3A-App vs. Standard Care (brief office visit and educational handouts). Families in the clinical trial were asked to use the software for two weeks and complete a standard care allergy office visit. This design enabled the investigators to evaluate combined effects of Standard Care and the F3A-App through typical treatment channels (e.g., is the greatest efficacy found after a physician refers family to use the App after an office visit?). Gains in families' knowledge and confidence in food allergy management were evaluated, and interviews with families were conducted to gain further input regarding the software's credibility, usability, and acceptability.
This entry describes only the RCT portion of this Phase II STTR project.
Read the detailed description
The central goal of this project was to develop an interactive, game-based application (App) for school-aged children (aged 8-12) with food allergies (FA) that would increase knowledge, improve behavioral skills for disease management, and ultimately reduce risk of negative outcomes. An effective FA intervention for children should target content areas of food avoidance and reaction management, and across these areas facilitate knowledge acquisition, develop behavioral skills, and provide practice using these skills in social contexts. The "Friends, Family, and Food App (F3A-App)", consists of four related parts: (a) an interactive, game-based application that is the core of the program, (b) the experiential scenarios in interactive environments (e.g., school cafeteria vignette) that target knowledge and behavioral skills practice in social contexts, (c) two engaging multi-level games to build skills in food avoidance (Label Learning: Like it or Lose it!) and symptom assessment (Reaction Action!), and (d) a multi-tiered reward system that uses token economy-based reinforcement to enhance motivation and engagement (SeaLife Spectacular). From a user perspective, the interactive, game-based application provides opportunities to practice behavioral skills (e.g. negotiating pressures to accept trigger foods, requesting assistance from adults, responding to teasing/bullying) in role-play situations with immediate feedback and reinforcement.
In this Phase II project, the investigators proposed to produce a fully-developed version of the F3A-App, including added content and enhanced features, and evaluate the final product in a randomized clinical trial.
The specific aims of Phase II were:
- To refine the F3A-App based on the user feedback and data collected in Phase I.
- To develop and field test additional content, including two additional interactive environments (family gathering, school pot-luck); and to increase gaming complexity (i.e., more levels and options) in Label Learning: Like it or Lose it! and Reaction Action! A small open trial was conducted, in which 40 children with FA, ages 8-12, used selected segments containing the newly developed content. Children used the application for 2 weeks on their home computer or tablet. Feedback about device preference and usage was used to determine the focus of the Evaluation Stage (Aim 3).
- To assess the efficacy of the F3A-App vs. Standard Care (brief office visit and educational handouts) in a randomized clinical trial with 100 children with FA, ages 8-12. The investigators expected the F3A-App would improve children's FA knowledge and self-efficacy to manage FA (primary outcomes) and would increase parent-child communication regarding FA management relative to Standard Care (secondary outcome). The study's crossover design also made it possible to evaluate combined effects of Standard Care and the F3A-App through typical treatment channels (e.g., is the greatest efficacy found after a physician refers family to use the App after an office visit?) This Phase II STTR targeted pediatric FA, a critical public health problem of increasing prevalence. The approach was innovative by incorporating an emphasis on behavioral skills practice using a platform that is engaging, interactive, affordable, and has high potential for broad dissemination. The researchers envision that the F3A-App will ultimately serve as a template for interactive, game-based applications for children with other chronic conditions requiring self-management, such as asthma, diabetes, and celiac disease.
This entry describes only the RCT portion of this Phase II STTR project.
- Conditions
- Food Allergy in Children
- Being tested
- Friends, Family, and Food App (F3A-App)
- Keywords
- food allergy, intervention, virtual, pediatric
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Friends, Family, and Food App (F3A-App)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Standard Care followed by F3A-App | Active comparator | The first portion of Arm A is a Standard Care (SC) office visit. Changes over time in Arm A represent a typical delivery channel in which a physician provides brief education and then encourages use of the F3A-App program. The SC intervention included a brief, structured office visit designed to replicate what would typically occur in a follow-up visit in an allergy clinic, and include provision standardized educational handouts available from the Food Allergy Research \& Education (FARE) website. The second phase of Arm A is use of the F3A-App. Receives: Behavioral: Friends, Family, and Food App (F3A-App) |
| Arm B: F3A-App followed by Standard Care | Active comparator | The first portion of Arm B is the use of the F3A-App for 2 weeks. Changes over time in Arm B represent an alternative delivery channel in which families use the F3A-App on their own and then have a follow-up office visit after using the self-guided program. The second phase of Arm B is the standard care office visit.
F3A-App efficacy vs. SC is evaluated after the first intervention period on primary outcomes. Receives: Behavioral: Friends, Family, and Food App (F3A-App) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Food Allergy Management Assessment Scale (FAMAS) scores
Semi-structured interview assessing various elements of food allergy (FA) management (caregiver and youth report). Domains of the scale are: FA knowledge, symptom assessment, family/child response to allergic reactions, family/child food avoidance, medication availability, alternate caregivers, parent/child anxiety related to FA, balanced integration of FA and family life. Higher scores on all scales indicate more optimal FA management. Klinnert, M.D., et al., Children's food allergies (FA): Development of the Food Allergy Management and Adaptation Scale (FAMAS). Journal of Allergy and Clinical Immunology, 2012. 129(AB299).
Measured: Change in various elements of FA management (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
Change in scores on the Food Allergy Independent Measure (FAIM)
The FAIM is a 4-item measure of anxiety related to the child's food allergy. Higher scores indicate a higher degree of anxiety. van der Velde J. L., Flokstra-de Blok B. M. J., Vlieg-Boerstra B. J., Oude Elberink G., DunnGalvin A., Hourihane J. B., Dubois A. E. J. (2010). Development validity and reliability of food allergy independent measure (FAIM). Allergy, 65, 630-635. doi: 10.1111/j.1398-9995.2009.02216.x
Measured: Change in FA-related anxiety (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
Change in scores on the Food Allergy Self-Efficacy
Self-efficacy related to self-treatment of Food Allergy (youth report). Higher scores indicate a higher level of self-efficacy. Bursch, B., et al., Construction and validation of four childhood asthma self-management scales: parent barriers, child and parent self-efficacy, and parent belief in treatment efficacy. J Asthma, 1999. 36(1): p. 115-28.
Measured: Change in self-efficacy related to self-tx of FA (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
Change in Food Allergy Knowledge scores
An assessment of the level of food allergy-related knowledge (youth report). Higher scores indicate better knowledge of FA. Sicherer, S.H., et al., Development and validation of educational materials for food allergy. Journal of Pediatrics, 2012. 160(4): p. 651-656.
Measured: Change in FA-related knowledge (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
Change in Parent-Child Communication related to Food Allergy
This measure was adapted from a parent-child communication assessment used to evaluate communication about sexual health. The Food Allergy adaptation evaluates the number of times parent and child discussed each of 6 FA management topics in prior week (e.g., using epinephrine) (caregiver and youth report). Huston, R.L. and L.J. Martin, Effect of a program to facilitate parent-chld communication about sex. Clinical Pediatrics, 1990. 29(11): p. 626-633.
- Schuster, M.A., et al., Evaluation of talking parents, healthy teens, a new worksite based parenting programme to promote parent-adolescent communication about sexual health: randomised controlled data. BMJ, 2008. 337(a308).
Measured: Change in amount of parent-child discussion related to FA (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start10 Mar 2016
- Primary completion15 May 2017
- Study completion19 May 2017
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 Allergy in ChildrenStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- AB/BA crossover: participants were randomized to Arm A (Standard Care (SC) then F3A-App), or Arm B (F3A-App then SC)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Virtually Better, Inc.
- Responsible party
- Sponsor
- Investigators
- Kathy Mann-Koepke, PhD, Study chair, Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111938
- Sponsor's protocol ID
- R42 HD075524 (RCT)
- Other IDs
- R42HD075524
- Acronym
- F3A-App
- Status last verified
- May 2021
- First submitted
- 7 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jandasek BN, Kopel SJ, Esteban CA, Rudders SA, Spitalnick JS, Larsen MA, Cushman GK, McQuaid EL. Friends, Family, and Food: Development of a Food Allergy Intervention, F3-App, for Children. Clin Pract Pediatr Psychol. 2024 Jun;12(2):143-156. doi: 10.1037/cpp0000513. Epub 2024 Jan 8.
PubMed 39045229
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Friends, Family and Food: Interactive Virtual Environments for Children With Food Allergies - II
- ClinicalTrials.gov ID
- NCT05111938
- Acronym / sponsor ID
- F3A-App / R42 HD075524 (RCT)
- Conditions
- Food Allergy in Children
- Keywords
- food allergy, intervention, virtual, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Virtually Better, Inc.
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 8 Nov 2021 (actual)
- 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.
Objective: This Phase II STTR grant incorporated user feedback collected in an earlier development project to build interactive, web-based software that helps children with food allergies learn about their condition and gain self-management skills. This highly interactive game allows children to progress through virtual scenes to help them learn about food avoidance, symptom detection, and reaction management. In addition, this project built gaming complexity, with more levels and game options, of the two interactive games "Label Learning: Like it or Lose it!" and "Reaction Action!." Research Procedures: The researchers elicited input from 8 families of children (ages 8-12) with food allergies and their parents by presenting some of preliminary intervention materials (e.g., storyboards of a child in a family gathering involving food) in a focus group format. After that, up to 40 families of children with food allergies (ages 8-12) were recruited to participate in an "open trial". Families were asked to use the software for two weeks and provide feedback on the software. Up to 100 families of children with food allergies (ages 8-12) were then recruited to participate in a Randomized Clinical Trial (RCT) to assess the efficacy of the F3A-App vs. Standard Care (brief office visit and educational handouts). Families in the clinical trial were asked to use the software for two weeks and complete a standard care allergy office visit. This design enabled the investigators to evaluate combined effects of Standard Care and the F3A-App through typical treatment channels (e.g., is the greatest efficacy found after a physician refers family to use the App after an office visit?). Gains in families' knowledge and confidence in food allergy management were evaluated, and interviews with families were conducted to gain further input regarding the software's credibility, usability, and acceptability.
This entry describes only the RCT portion of this Phase II STTR project.
Detailed description
The central goal of this project was to develop an interactive, game-based application (App) for school-aged children (aged 8-12) with food allergies (FA) that would increase knowledge, improve behavioral skills for disease management, and ultimately reduce risk of negative outcomes. An effective FA intervention for children should target content areas of food avoidance and reaction management, and across these areas facilitate knowledge acquisition, develop behavioral skills, and provide practice using these skills in social contexts. The "Friends, Family, and Food App (F3A-App)", consists of four related parts: (a) an interactive, game-based application that is the core of the program, (b) the experiential scenarios in interactive environments (e.g., school cafeteria vignette) that target knowledge and behavioral skills practice in social contexts, (c) two engaging multi-level games to build skills in food avoidance (Label Learning: Like it or Lose it!) and symptom assessment (Reaction Action!), and (d) a multi-tiered reward system that uses token economy-based reinforcement to enhance motivation and engagement (SeaLife Spectacular). From a user perspective, the interactive, game-based application provides opportunities to practice behavioral skills (e.g. negotiating pressures to accept trigger foods, requesting assistance from adults, responding to teasing/bullying) in role-play situations with immediate feedback and reinforcement.
In this Phase II project, the investigators proposed to produce a fully-developed version of the F3A-App, including added content and enhanced features, and evaluate the final product in a randomized clinical trial.
The specific aims of Phase II were:
- To refine the F3A-App based on the user feedback and data collected in Phase I.
- To develop and field test additional content, including two additional interactive environments (family gathering, school pot-luck); and to increase gaming complexity (i.e., more levels and options) in Label Learning: Like it or Lose it! and Reaction Action! A small open trial was conducted, in which 40 children with FA, ages 8-12, used selected segments containing the newly developed content. Children used the application for 2 weeks on their home computer or tablet. Feedback about device preference and usage was used to determine the focus of the Evaluation Stage (Aim 3).
- To assess the efficacy of the F3A-App vs. Standard Care (brief office visit and educational handouts) in a randomized clinical trial with 100 children with FA, ages 8-12. The investigators expected the F3A-App would improve children's FA knowledge and self-efficacy to manage FA (primary outcomes) and would increase parent-child communication regarding FA management relative to Standard Care (secondary outcome). The study's crossover design also made it possible to evaluate combined effects of Standard Care and the F3A-App through typical treatment channels (e.g., is the greatest efficacy found after a physician refers family to use the App after an office visit?) This Phase II STTR targeted pediatric FA, a critical public health problem of increasing prevalence. The approach was innovative by incorporating an emphasis on behavioral skills practice using a platform that is engaging, interactive, affordable, and has high potential for broad dissemination. The researchers envision that the F3A-App will ultimately serve as a template for interactive, game-based applications for children with other chronic conditions requiring self-management, such as asthma, diabetes, and celiac disease.
This entry describes only the RCT portion of this Phase II STTR project.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- AB/BA crossover: participants were randomized to Arm A (Standard Care (SC) then F3A-App), or Arm B (F3A-App then SC)
| Arm | Type | Receives |
|---|---|---|
| Arm A: Standard Care followed by F3A-App | Active comparator | Behavioral: Friends, Family, and Food App (F3A-App)The first portion of Arm A is a Standard Care (SC) office visit. Changes over time in Arm A represent a typical delivery channel in which a physician provides brief education and then encourages use of the F3A-App program. The SC intervention included a brief, structured office visit designed to replicate what would typically occur in a follow-up visit in an allergy clinic, and include provision standardized educational handouts available from the Food Allergy Research \& Education (FARE) website. The second phase of Arm A is use of the F3A-App. |
| Arm B: F3A-App followed by Standard Care | Active comparator | Behavioral: Friends, Family, and Food App (F3A-App)The first portion of Arm B is the use of the F3A-App for 2 weeks. Changes over time in Arm B represent an alternative delivery channel in which families use the F3A-App on their own and then have a follow-up office visit after using the self-guided program. The second phase of Arm B is the standard care office visit. F3A-App efficacy vs. SC is evaluated after the first intervention period on primary outcomes. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- child must be 8-12
- child must have an active diagnosis of FA, confirmed by a physician
- child and parent must speak and read English
- child must have access to a computer with internet access
- child must have access to a smartphone or table
Key exclusion criteria (1 listed)
- any chronic health condition requiring substantial dietary self-management (e.g., diabetes)
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 |
|---|---|---|
| Friends, Family, and Food App (F3A-App) | Behavioural | Arm A: Standard Care followed by F3A-App, Arm B: F3A-App followed by Standard Care |
Primary outcome
Change in Food Allergy Management Assessment Scale (FAMAS) scores
Time frame: Change in various elements of FA management (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
Semi-structured interview assessing various elements of food allergy (FA) management (caregiver and youth report). Domains of the scale are: FA knowledge, symptom assessment, family/child response to allergic reactions, family/child food avoidance, medication availability, alternate caregivers, parent/child anxiety related to FA, balanced integration of FA and family life. Higher scores on all scales indicate more optimal FA management. Klinnert, M.D., et al., Children's food allergies (FA): Development of the Food Allergy Management and Adaptation Scale (FAMAS). Journal of Allergy and Clinical Immunology, 2012. 129(AB299).
Change in scores on the Food Allergy Independent Measure (FAIM)
Time frame: Change in FA-related anxiety (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
The FAIM is a 4-item measure of anxiety related to the child's food allergy. Higher scores indicate a higher degree of anxiety. van der Velde J. L., Flokstra-de Blok B. M. J., Vlieg-Boerstra B. J., Oude Elberink G., DunnGalvin A., Hourihane J. B., Dubois A. E. J. (2010). Development validity and reliability of food allergy independent measure (FAIM). Allergy, 65, 630-635. doi: 10.1111/j.1398-9995.2009.02216.x
Change in scores on the Food Allergy Self-Efficacy
Time frame: Change in self-efficacy related to self-tx of FA (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
Self-efficacy related to self-treatment of Food Allergy (youth report). Higher scores indicate a higher level of self-efficacy. Bursch, B., et al., Construction and validation of four childhood asthma self-management scales: parent barriers, child and parent self-efficacy, and parent belief in treatment efficacy. J Asthma, 1999. 36(1): p. 115-28.
Change in Food Allergy Knowledge scores
Time frame: Change in FA-related knowledge (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
An assessment of the level of food allergy-related knowledge (youth report). Higher scores indicate better knowledge of FA. Sicherer, S.H., et al., Development and validation of educational materials for food allergy. Journal of Pediatrics, 2012. 160(4): p. 651-656.
Change in Parent-Child Communication related to Food Allergy
Time frame: Change in amount of parent-child discussion related to FA (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)
This measure was adapted from a parent-child communication assessment used to evaluate communication about sexual health. The Food Allergy adaptation evaluates the number of times parent and child discussed each of 6 FA management topics in prior week (e.g., using epinephrine) (caregiver and youth report). Huston, R.L. and L.J. Martin, Effect of a program to facilitate parent-chld communication about sex. Clinical Pediatrics, 1990. 29(11): p. 626-633. 45. Schuster, M.A., et al., Evaluation of talking parents, healthy teens, a new worksite based parenting programme to promote parent-adolescent communication about sexual health: randomised controlled data. BMJ, 2008. 337(a308).
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 8 Nov 2021.
- Derived from this study: PubMed 39045229Jandasek BN, Kopel SJ, Esteban CA, Rudders SA, Spitalnick JS, Larsen MA, Cushman GK, McQuaid EL. Friends, Family, and Food: Development of a Food Allergy Intervention, F3-App, for Children. Clin Pract Pediatr Psychol. 2024 Jun;12(2):143-156. doi: 10.1037/cpp0000513. Epub 2024 Jan 8.
- Individual participant dataSharing planned: No
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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.
Kathy Mann-Koepke, PhD study chair
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Questions about this trial
What is this clinical trial studying?
A study testing Friends, Family, and Food App (F3A-App) in people with Food Allergy in Children, run by Rhode Island Hospital.
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 5 inclusion and 1 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 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in Food Allergy Management Assessment Scale (FAMAS) scores (time frame: Change in various elements of FA management (pre/post F3A-App use or Standard Care office visit, depending on randomized group assignment)). The study lists 5 primary outcomes in all. 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 NCT05111938, 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 8 Nov 2021.