NCT06117098

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Oslo Metropolitan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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"
BEHAVIORAL	Group-based lifestyle intervention	Group-based life style intervention at a Healthy Lifestyle Centre (ususal care)

Timeline

• Start date: 2023-05-02
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2023-11-03
• Last updated: 2023-11-03

Locations

1 site across 1 country: Norway