Child ObesityNCT05261555
Mixed Methods Feasibility Study of an App for Childhood Obesity Prevention and Management
A study testing NoObesity app in people with Child Obesity, run by University of Plymouth at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Obesity
- What is being tested?
- NoObesity app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jun 2020to 23 Aug 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Child Obesity
- Being tested
- NoObesity app
- Keywords
- child obesity, digital health, mobile applications, behavior change
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoObesity appDevice
The NoObesity system consists of two linked apps - the NoObesity Family app and the NoObesity Professional app.
| Study group | Role | What they receive |
|---|---|---|
| Using the NoObesity app | Experimental | 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. Receives: Device: NoObesity app |
What is being measured
The primary outcome is the main question the study is designed to answer.
User experiences and acceptability of the NoObesity app
Measured qualitatively through semi-structured interviews to examine what participants liked, disliked, and what they thought could be improved
Measured: 6 months
Secondary outcomes (9)
Usability of the NoObesity app
Measured using the System Usability Scale (minimum of 0, maximum of 100, higher scores indicate better usability)
Measured: 6 months
Qualitative user perspectives of usability
Qualitative feedback from semi-structured interviews
Measured: 6 months
Perceived impact of app on motivation
Qualitative feedback from semi-structured interviews
Measured: 6 months
Perceived impact of specific app features on motivation
Measured quantitatively on self-report final survey
Measured: 6 months
Perceived impact of app on health behaviours
Qualitative feedback from semi-structured interviews
Measured: 6 months
Self-reported impact of the app on health behaviours
Measured quantitatively on self-report final survey
Measured: 6 months
Perceived impact of app on self-efficacy
Measured quantitatively by assessing users' confidence in their ability to achieve goals in the app and in the final survey
Measured: 6 months
Engagement with the app
Measured using app use data (first and last logins) and self-reported engagement with the app
Measured: 6 months
Factors relating to adoption, implementation, and sustainability
Measured qualitatively in semi-structured interviews with participants and representatives from Health Education England
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start27 Jun 2020
- Primary completion28 Apr 2021
- Study completion23 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Collaborators
- Health Education England, Wessex
- Responsible party
- Principal investigator, Edward Meinert, PhD, University of Plymouth
- Investigators
- Edward Meinert, PhD, Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261555
- Sponsor's protocol ID
- R62092/RE001
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meinert E, Rahman E, Potter A, Lawrence W, Van Velthoven M. Acceptability and Usability of the Mobile Digital Health App NoObesity for Families and Health Care Professionals: Protocol for a Feasibility Study. JMIR Res Protoc. 2020 Jul 22;9(7):e18068. doi: 10.2196/18068.
PubMed 32706703Milne-Ives M, Homer SR, Andrade J, Meinert E. Mapping the Process of Engagement With Digital Health Interventions: A Cross-Case Synthesis. Mayo Clin Proc Innov Qual Outcomes. 2025 May 27;9(3):100625. doi: 10.1016/j.mayocpiqo.2025.100625. eCollection 2025 Jun.
PubMed 40503087Milne-Ives M, Rahman E, Bradwell H, Baines R, Boey T, Potter A, Lawrence W, Helena van Velthoven M, Meinert E. Barriers and facilitators to parents' engagement with and perceived impact of a childhood obesity app: A mixed-methods study. PLOS Digit Health. 2024 Mar 27;3(3):e0000481. doi: 10.1371/journal.pdig.0000481. eCollection 2024 Mar.
PubMed 38536852
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Usability of a Mobile Health App for Family Obesity Prevention and Management: A Mixed-methods Feasibility Study
- ClinicalTrials.gov ID
- NCT05261555
- Acronym / sponsor ID
- R62092/RE001
- Conditions
- Child Obesity
- Keywords
- child obesity, digital health, mobile applications, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Collaborators
- Health Education England, Wessex
- Study start
- 27 Jun 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 2 Mar 2022 (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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Using the NoObesity app | Experimental | Device: NoObesity appA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| NoObesity appThe NoObesity system consists of two linked apps - the NoObesity Family app and the NoObesity Professional app. | Device | Using the NoObesity app |
Primary outcome
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
9 secondary outcomes
Usability of the NoObesity app
Time frame: 6 months
Qualitative user perspectives of usability
Time frame: 6 months
Perceived impact of app on motivation
Time frame: 6 months
Perceived impact of specific app features on motivation
Time frame: 6 months
Perceived impact of app on health behaviours
Time frame: 6 months
Self-reported impact of the app on health behaviours
Time frame: 6 months
Perceived impact of app on self-efficacy
Time frame: 6 months
Engagement with the app
Time frame: 6 months
Factors relating to adoption, implementation, and sustainability
Time frame: 6 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 2 Mar 2022.
- Background: PubMed 32706703Meinert E, Rahman E, Potter A, Lawrence W, Van Velthoven M. Acceptability and Usability of the Mobile Digital Health App NoObesity for Families and Health Care Professionals: Protocol for a Feasibility Study. JMIR Res Protoc. 2020 Jul 22;9(7):e18068. doi: 10.2196/18068.
- Derived from this study: PubMed 40503087Milne-Ives M, Homer SR, Andrade J, Meinert E. Mapping the Process of Engagement With Digital Health Interventions: A Cross-Case Synthesis. Mayo Clin Proc Innov Qual Outcomes. 2025 May 27;9(3):100625. doi: 10.1016/j.mayocpiqo.2025.100625. eCollection 2025 Jun.
- Derived from this study: PubMed 38536852Milne-Ives M, Rahman E, Bradwell H, Baines R, Boey T, Potter A, Lawrence W, Helena van Velthoven M, Meinert E. Barriers and facilitators to parents' engagement with and perceived impact of a childhood obesity app: A mixed-methods study. PLOS Digit Health. 2024 Mar 27;3(3):e0000481. doi: 10.1371/journal.pdig.0000481. eCollection 2024 Mar.
- 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.
Edward Meinert, PhD principal investigator
University of Plymouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NoObesity app in people with Child Obesity, run by University of Plymouth at 1 site in United Kingdom.
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 5 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 2 Mar 2022. 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 Kingdom. 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. 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?
User experiences and acceptability of the NoObesity app (time frame: 6 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 NCT05261555, which also lists 3 linked publications.
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 2 Mar 2022.