Mobile App for Risk Reduction of Type 2 Diabetes
Stepping Stones for Successful Evaluation of Mobile App Efficacy for Risk Reduction of Type 2 Diabetes
1 other identifier
interventional
60
1 country
1
Brief 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. This will be investigated through a feasibility study (small scale RCT) on the efficacy of mobile technology on risk reduction of type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2023
CompletedFirst Submitted
Initial submission to the registry
May 31, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedNovember 3, 2023
March 1, 2023
8 months
May 31, 2023
October 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
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.
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.
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.
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.
Three months
Secondary Outcomes (1)
Antropometric measures
Three months
Study Arms (3)
Mobile application
EXPERIMENTALThis group will receive individual guidance via the mobile application (12 weeks)
Group-based lifestyle intervention at the Healthy Lifestyle Centres
ACTIVE COMPARATORThis 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
EXPERIMENTALThis group will receive a group-based lifestyle intervention program at a Healthy Lifestyle Centre plus the mobile application (12 weeks)
Interventions
Individual lifestyle intervention via an mobile application
Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application"
Group-based life style intervention at a Healthy Lifestyle Centre (ususal care)
Eligibility Criteria
You may qualify if:
- smart phone
- prediabetes
You may not qualify if:
- not interested in lifestyle change
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OsloMet
Oslo, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Birgitta Blakstad Nilsson, Phd
OsloMet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2023
First Posted
November 3, 2023
Study Start
May 2, 2023
Primary Completion
December 31, 2023
Study Completion
June 30, 2024
Last Updated
November 3, 2023
Record last verified: 2023-03