Prediabetic StateNCT06117098
Mobile App for Risk Reduction of Type 2 Diabetes
A study testing Mobile application, Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application" and Group-based lifestyle intervention in people with Prediabetic State, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
The aim of this feasibility study is to investigate whether a full scale RCT on the efficacy of a mobile app for risk reduction on type 2 diabetes can be conducted in the way it is planned or whether it needs to be modified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Mobile application, Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application" and Group-based lifestyle intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 2 May 2023to 30 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- smart phone
- prediabetes
Who cannot join
- not interested in lifestyle change
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stepping Stones for Successful Evaluation of Mobile App Efficacy for Risk Reduction of Type 2 Diabetes
The aim of this feasibility study is to investigate whether a full scale RCT on the efficacy of a mobile app for risk reduction on type 2 diabetes can be conducted in the way it is planned or whether it needs to be modified. This will be investigated through a feasibility study (small scale RCT) on the efficacy of mobile technology on risk reduction of type 2 diabetes.
Read the detailed description
A small scale RCT will be carried out a the collaborating Healthy Life Centres (HLC). Trained health personnel will deliver the lifestyle programs at these centres, and the content of their programs should be in line with the national guidelines for physical activity and nutrition. The study sample 60 participants with high risk of developing diabetes type 2.
The participants will be randomized into three study arms, 20 participants in each. One group, the intervention group, will receive the mobile app, the second group will receive group-based lifestyle intervention at the HLCs and the third group will receive group based lifestyle intervention at the HLCs and a mobile application. The middle arm will serve as the control arm for both the non-inferiority trial ( mobile application group and HLC lifestyle intervention only) and for the superiority trial (HLC lifestyle intervention plus mobile app and HLC intervention only).
- Conditions
- Prediabetic State
- Being tested
- Mobile application, Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application", Group-based lifestyle intervention
- Keywords
- Prevention
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationDevice
Individual lifestyle intervention via an mobile application
Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application"Behavioural
Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application"
Group-based lifestyle interventionBehavioural
Group-based life style intervention at a Healthy Lifestyle Centre (ususal care)
| Study group | Role | What they receive |
|---|---|---|
| Mobile application | Experimental | This group will receive individual guidance via the mobile application (12 weeks) Receives: Device: Mobile application |
| Group-based lifestyle intervention at the Healthy Lifestyle Centres | Active comparator | This group will receive a group-based lifestyle intervention program at a Healthy Lifestyle Centre (12 weeks) Receives: Behavioral: Group-based lifestyle intervention |
| Group-based lifestyle intervention at a Healthy Lifestyle Centre and recieving a mobile application | Experimental | This group will receive a group-based lifestyle intervention program at a Healthy Lifestyle Centre plus the mobile application (12 weeks) Receives: Behavioral: Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
We want to assess the proportion of participants willing and able to take part in the study after referral from general practitioner in two different regions in East Norway. Information will be recorded continuously after telephone contact.
Measured: Six months
Resources
We will assess the randomization procedure and asses time spent on the first consultation with the participants. Throughout the study period, the supervisor will log all time spent monitoring participants and giving individual feedback through the app.
Measured: Nine months
Management
The use of the app will be registered in terms of actual use and if patients answered tasks within a week, all based on data shown in the administrator interface. Data on adherence to provided tasks and problems experienced with the mobile app will be retrieved from the app-database. We will also assess whether there are any problems with data management involved in the study and assess whether the study personnel had any challenges in conduct of the study.
Measured: Nine months
Satisfaction with the app
User satisfaction with the application will be assessed with the System Usability Scale. (SUS), a paper questionnaire at the end of the intervention.The SUS is a technology independent, 10-item questionnaire with a score between 0 and 100 were 0 represents low usability and 100 represent high usability. We will also asses the experienced usefulness of the app after 12 weeks. This will be measured through a questionnaire designed for this study consisting of 16 questions; 13 questions with answers on a Likert scale (0 to 100), 3 multiple-choice questions, and 1 open-ended question.
Measured: Three months
Change and ceiling and floor effect in outcomes
These outcomes will be determined by evaluating whether changes in quality of life and physical activity over a 12-week period could be observed and whether these outcomes disclose ceiling or floor effects. To assess these domains, we will use part of standard questionnaires being used in Healthy Life Centers at the beginning and ending of a 12-week intervention period, being the COOP/WONCA (the Dartmount COOP/World Organization of Family Doctors functional health assessment). This is a questionnaire assessing changes in quality of life.It consists of six questions across six domains with a score of 1 in each domain representing the best possible score while a score of 5 is the worst possible score. Physical activity will be assessed with the validated International Physical Activity Questionnaire (IPAQ) short form. It consists of eight items and encompasses questions regarding time spent walking, in moderate and vigorous intensity physical activity, besides sitting time.
Measured: Three months
Secondary outcomes (1)
Antropometric measures
Weight and waist circumference will be measured at baseline and at the end of the intervention period.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start2 May 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
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 Prediabetic StateStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT feasibility study, non-inferiority and superiority trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birgitta Blakstad Nilsson, Phd, Principal investigator, OsloMet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117098
- Sponsor's protocol ID
- 887029
- Status last verified
- Mar 2023
- First submitted
- 31 May 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Skoglund G, Hilde G, Lunde P, Cruz Naceno VV, Fromholt Olsen C, Blakstad Nilsson B. Mobile Phone App to Promote Lifestyle Change in People at Risk of Type 2 Diabetes: Feasibility 3-Arm Randomized Controlled Trial. JMIR Form Res. 2025 Jan 15;9:e63737. doi: 10.2196/63737.
PubMed 39864814
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepping Stones for Successful Evaluation of Mobile App Efficacy for Risk Reduction of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06117098
- Acronym / sponsor ID
- 887029
- Conditions
- Prediabetic State
- Keywords
- Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 3 Nov 2023 (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.
The aim of this feasibility study is to investigate whether a full scale RCT on the efficacy of a mobile app for risk reduction on type 2 diabetes can be conducted in the way it is planned or whether it needs to be modified. This will be investigated through a feasibility study (small scale RCT) on the efficacy of mobile technology on risk reduction of type 2 diabetes.
Detailed description
A small scale RCT will be carried out a the collaborating Healthy Life Centres (HLC). Trained health personnel will deliver the lifestyle programs at these centres, and the content of their programs should be in line with the national guidelines for physical activity and nutrition. The study sample 60 participants with high risk of developing diabetes type 2.
The participants will be randomized into three study arms, 20 participants in each. One group, the intervention group, will receive the mobile app, the second group will receive group-based lifestyle intervention at the HLCs and the third group will receive group based lifestyle intervention at the HLCs and a mobile application. The middle arm will serve as the control arm for both the non-inferiority trial ( mobile application group and HLC lifestyle intervention only) and for the superiority trial (HLC lifestyle intervention plus mobile app and HLC intervention only).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- RCT feasibility study, non-inferiority and superiority trial
| Arm | Type | Receives |
|---|---|---|
| Mobile application | Experimental | Device: Mobile applicationThis group will receive individual guidance via the mobile application (12 weeks) |
| Group-based lifestyle intervention at the Healthy Lifestyle Centres | Active comparator | Behavioral: Group-based lifestyle interventionThis group will receive a group-based lifestyle intervention program at a Healthy Lifestyle Centre (12 weeks) |
| Group-based lifestyle intervention at a Healthy Lifestyle Centre and recieving a mobile application | Experimental | Behavioral: Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application"This group will receive a group-based lifestyle intervention program at a Healthy Lifestyle Centre plus the mobile application (12 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- smart phone
- prediabetes
Key exclusion criteria (1 listed)
- not interested in lifestyle change
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 |
|---|---|---|
| Mobile applicationIndividual lifestyle intervention via an mobile application | Device | Mobile application |
| Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application"Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application" | Behavioural | Group-based lifestyle intervention at a Healthy Lifestyle Centre and recieving a mobile application |
| Group-based lifestyle interventionGroup-based life style intervention at a Healthy Lifestyle Centre (ususal care) | Behavioural | Group-based lifestyle intervention at the Healthy Lifestyle Centres |
Primary outcome
Recruitment rate
Time frame: Six months
We want to assess the proportion of participants willing and able to take part in the study after referral from general practitioner in two different regions in East Norway. Information will be recorded continuously after telephone contact.
Resources
Time frame: Nine months
We will assess the randomization procedure and asses time spent on the first consultation with the participants. Throughout the study period, the supervisor will log all time spent monitoring participants and giving individual feedback through the app.
Management
Time frame: Nine months
The use of the app will be registered in terms of actual use and if patients answered tasks within a week, all based on data shown in the administrator interface. Data on adherence to provided tasks and problems experienced with the mobile app will be retrieved from the app-database. We will also assess whether there are any problems with data management involved in the study and assess whether the study personnel had any challenges in conduct of the study.
Satisfaction with the app
Time frame: Three months
User satisfaction with the application will be assessed with the System Usability Scale. (SUS), a paper questionnaire at the end of the intervention.The SUS is a technology independent, 10-item questionnaire with a score between 0 and 100 were 0 represents low usability and 100 represent high usability. We will also asses the experienced usefulness of the app after 12 weeks. This will be measured through a questionnaire designed for this study consisting of 16 questions; 13 questions with answers on a Likert scale (0 to 100), 3 multiple-choice questions, and 1 open-ended question.
Change and ceiling and floor effect in outcomes
Time frame: Three months
These outcomes will be determined by evaluating whether changes in quality of life and physical activity over a 12-week period could be observed and whether these outcomes disclose ceiling or floor effects. To assess these domains, we will use part of standard questionnaires being used in Healthy Life Centers at the beginning and ending of a 12-week intervention period, being the COOP/WONCA (the Dartmount COOP/World Organization of Family Doctors functional health assessment). This is a questionnaire assessing changes in quality of life.It consists of six questions across six domains with a score of 1 in each domain representing the best possible score while a score of 5 is the worst possible score. Physical activity will be assessed with the validated International Physical Activity Questionnaire (IPAQ) short form. It consists of eight items and encompasses questions regarding time spent walking, in moderate and vigorous intensity physical activity, besides sitting time.
1 secondary outcome
Antropometric measures
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Derived from this study: PubMed 39864814Skoglund G, Hilde G, Lunde P, Cruz Naceno VV, Fromholt Olsen C, Blakstad Nilsson B. Mobile Phone App to Promote Lifestyle Change in People at Risk of Type 2 Diabetes: Feasibility 3-Arm Randomized Controlled Trial. JMIR Form Res. 2025 Jan 15;9:e63737. doi: 10.2196/63737.
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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.
Birgitta Blakstad Nilsson, Phd principal investigator
OsloMet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application, Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application" and Group-based lifestyle intervention in people with Prediabetic State, run by Oslo Metropolitan University at 1 site in Norway.
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 2 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: status not confirmed, as of the sponsor's last update on 3 Nov 2023. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgitta Blakstad Nilsson, Phd (+47 93210913, biblni@oslomet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Six months). 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 NCT06117098, 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 3 Nov 2023.