- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05261555
Mixed Methods Feasibility Study of an App for Childhood Obesity Prevention and Management
February 18, 2022 updated by: Edward Meinert, PhD, University of Plymouth
Acceptability and Usability of a Mobile Health App for Family Obesity Prevention and Management: A Mixed-methods Feasibility Study
This evaluation evaluated Health Education England's NoObesity digital health app's usability and acceptability to undertake activities improving families' diet, physical activity and weight.
The purpose of the study is to evaluate the app's influence on self-efficacy and goal setting and to determine what can be learned to improve its design for future studies, should there be evidence of adoption and sustainability.
Study Overview
Study Type
Interventional
Enrollment (Actual)
231
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Devon
-
Plymouth, Devon, United Kingdom, PL4 6DN
- University of Plymouth
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult users (over 18 years)
- fluent in English
- willing to use the app
- parents or legal guardians of a child or children OR health care professionals linked to the parent or guardian
- owner of a smartphone to access the app, with 4G data access
Exclusion Criteria:
- individuals who are known to the researchers or staff at Health Education England
- deaf or hearing impairment
- prior use of the app before study commencement
- refusal to give informed consent
- children, vulnerable young people, or vulnerable adults.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Using the NoObesity app
A mobile digital app ("NoObesity") that enables families to set goals, track progress, play games, and access additional information and healthcare professionals to access training and monitor patients' progress.
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The NoObesity system consists of two linked apps - the NoObesity Family app and the NoObesity Professional app.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
User experiences and acceptability of the NoObesity app
Time Frame: 6 months
|
Measured qualitatively through semi-structured interviews to examine what participants liked, disliked, and what they thought could be improved
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usability of the NoObesity app
Time Frame: 6 months
|
Measured using the System Usability Scale (minimum of 0, maximum of 100, higher scores indicate better usability)
|
6 months
|
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Qualitative user perspectives of usability
Time Frame: 6 months
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Qualitative feedback from semi-structured interviews
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6 months
|
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Perceived impact of app on motivation
Time Frame: 6 months
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Qualitative feedback from semi-structured interviews
|
6 months
|
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Perceived impact of specific app features on motivation
Time Frame: 6 months
|
Measured quantitatively on self-report final survey
|
6 months
|
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Perceived impact of app on health behaviours
Time Frame: 6 months
|
Qualitative feedback from semi-structured interviews
|
6 months
|
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Self-reported impact of the app on health behaviours
Time Frame: 6 months
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Measured quantitatively on self-report final survey
|
6 months
|
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Perceived impact of app on self-efficacy
Time Frame: 6 months
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Measured quantitatively by assessing users' confidence in their ability to achieve goals in the app and in the final survey
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6 months
|
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Engagement with the app
Time Frame: 6 months
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Measured using app use data (first and last logins) and self-reported engagement with the app
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6 months
|
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Factors relating to adoption, implementation, and sustainability
Time Frame: 6 months
|
Measured qualitatively in semi-structured interviews with participants and representatives from Health Education England
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Edward Meinert, PhD, University of Plymouth
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 27, 2020
Primary Completion (ACTUAL)
April 28, 2021
Study Completion (ACTUAL)
August 23, 2021
Study Registration Dates
First Submitted
February 8, 2022
First Submitted That Met QC Criteria
February 18, 2022
First Posted (ACTUAL)
March 2, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 2, 2022
Last Update Submitted That Met QC Criteria
February 18, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R62092/RE001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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