Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer

NCT05460650 | Completed

• 1 other identifier: REC 22/WA/0164
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

It is estimated that around 20% of breast cancers (BC) in the UK are preventable through adherence to appropriate health behaviours, i.e., healthy diet, physical activity, limited alcohol, not smoking, and that women at increased risk of BC could benefit from greater decreases in risk than the general population via health behaviour changes. Young women (age \<35 years) who are at increased risk of developing BC currently receive little or no information regarding health behaviours and BC risk, or support for behaviour change. This feasibility study aims to explore whether a novel app is acceptable to women at increased risk and could potentially engage them with improved health behaviours which could reduce their future risk of BC.

Conditions

Breast Cancer; Overweight and Obesity; Diet, Healthy; Weight Gain; Alcohol Drinking; Smoking Behaviors; Healthy Nutrition; Healthy Lifestyle; Healthy Eating Index

Outcome Measures

Primary Outcomes (1)

• Acceptability and usability of the app

  Assess acceptability and usability of the app by interviews

  Two months

Secondary Outcomes (5)

• Acceptability of study recruitment, consent and trial procedures

  Two months

• Study uptake numbers via invite letter and social media posts

  Two months

• Acceptability and usability of the app via questionnaire

  Two months

• Errors in app data entry

  Two months

• Number of interactions with the private Facebook group

  Two months

Study Arms (1)

Receives app

EXPERIMENTAL

All women in the study will receive access to the app.

Behavioral: App Promoting Healthy Behaviours

Interventions

App Promoting Healthy Behaviours BEHAVIORAL

Women on the study will receive two months access to the app.

Receives app

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• 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)

You may not qualify if:

• Previous BC (other cancers will not be excluded)
• 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

Sponsors & Collaborators

• University of Manchester: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36525287 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Overweight; Obesity; Weight Gain; Alcohol Drinking; Smoking

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Dietitian

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 15, 2022
• Study Start: November 3, 2022
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After data analysis is complete, the fully anonymised data will be uploaded on to Figshare as per University of Manchester guidance and will remain there indefinitely.

Locations

GB (1)