Mobile App for Risk Reduction of Type 2 Diabetes

Oslo Metropolitan University

Status: Enrolling

Conditions: Prediabetic State

Treatments: Behavioral: Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application"; Behavioral: Group-based lifestyle intervention; Device: Mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT06117098

887029

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• smart phone
• prediabetes

Exclusion criteria

• not interested in lifestyle change

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Mobile application

Experimental group

Description:

This group will receive individual guidance via the mobile application (12 weeks)

Treatment:

Device: Mobile application

Group-based lifestyle intervention at the Healthy Lifestyle Centres

Active Comparator group

Description:

This group will receive a group-based lifestyle intervention program at a Healthy Lifestyle Centre (12 weeks)

Treatment:

Behavioral: Group-based lifestyle intervention

Group-based lifestyle intervention at a Healthy Lifestyle Centre and recieving a mobile application

Experimental group

Description:

This group will receive a group-based lifestyle intervention program at a Healthy Lifestyle Centre plus the mobile application (12 weeks)

Treatment:

Behavioral: Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application"