Mobile App for Risk Reduction of Type 2 Diabetes

Prediabetic State Clinical Trial

Official title:

Stepping Stones for Successful Evaluation of Mobile App Efficacy for Risk Reduction of Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117098
• Other study ID #: 887029
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: Oslo Metropolitan University
• Contact: Birgitta Blakstad Nilsson, Phd
• Phone: +47 93210913
• Email: biblni[@]oslomet.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This will be investigated through a feasibility study (small scale RCT) on the efficacy of mobile technology on risk reduction of type 2 diabetes.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• smart phone

• prediabetes

Exclusion Criteria:

• not interested in lifestyle change

Related Conditions & MeSH terms

• Prediabetic State

Intervention

Device:
• Mobile application
Individual lifestyle intervention via an mobile application

Behavioral:
• Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application"
Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application"
• Group-based lifestyle intervention
Group-based life style intervention at a Healthy Lifestyle Centre (ususal care)

Locations

Country	Name	City	State
Norway	OsloMet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Antropometric measures	Weight and waist circumference will be measured at baseline and at the end of the intervention period.	Three months