Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer
NCT ID: NCT05460650
Last Updated: 2023-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2022-11-03
2023-03-10
Brief Summary
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Detailed Description
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1. To assess the acceptability and usability of the app to young women at increased risk of BC
2. To assess the feasibility of study procedures before running a future efficacy study using the app as an intervention
Objectives
1. Explore views of users of the experiences during and after using the app
2. Explore views of users on their experience of the two different recruitment procedures (targeted mailshot, or social media, newsletters and websites), and the online consent procedure.
3. Interpret user data from the app including frequency and patterns of use of the different functions
4. Analyse recruitment data to explore how the two different recruitment procedures could be improved for the next study
5. Assemble a list of suggested changes to recruitment and consent procedures, and to the app, to be considered before the next study.
6. Quantify health care professional (HCP) time required for administering the private Facebook chat group, and through e-mail/private message support.
7. Quantify researcher time required for cleaning and analysis of app data.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Receives app
All women in the study will receive access to the app.
App Promoting Healthy Behaviours
Women on the study will receive two months access to the app.
Interventions
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App Promoting Healthy Behaviours
Women on the study will receive two months access to the app.
Eligibility Criteria
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Inclusion Criteria
* Age 18-35 years
* Live in the UK
* Moderate or high risk of BC (see 6.5 for definition)
* Ability to communicate in English
* Ability to download and use an app (available on both ioS and Android)
Exclusion Criteria
* Previous preventative mastectomy
* Currently trying to gain weight
* Previous weight loss surgery
* Currently taking weight loss medication, prescribed (for example orlistat, liraglutide, Naltrexone/Bupropion \[Mysimba\]) or other
* Have a medical condition that influences diet and weight, for example, diabetes, inflammatory bowel disease or cystic fibrosis
* Current diagnosis of a psychiatric disorder, for example bipolar psychotic disorder or current self-harm
* Current alcohol or drug dependency
* Current or previous diagnosis of an eating disorder
18 Years
35 Years
FEMALE
Yes
Sponsors
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Manchester University NHS Foundation Trust
OTHER_GOV
University of Manchester
OTHER
Responsible Party
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Mary Pegington
Senior Research Dietitian
Locations
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Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Pegington M, Davies A, Mueller J, Cholerton R, Howell A, Evans DG, Howell SJ, French DP, Harvie M. Evaluating the Acceptance and Usability of an App Promoting Weight Gain Prevention and Healthy Behaviors Among Young Women With a Family History of Breast Cancer: Protocol for an Observational Study. JMIR Res Protoc. 2022 Dec 16;11(12):e41246. doi: 10.2196/41246.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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REC 22/WA/0164
Identifier Type: -
Identifier Source: org_study_id
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