Mobile App for Risk Reduction of Type 2 Diabetes

NCT ID: NCT06117098

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-02

Study Completion Date

2024-06-30

Brief Summary

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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

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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

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Prediabetic State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT feasibility study, non-inferiority and superiority trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mobile application

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

Group Type EXPERIMENTAL

Mobile application

Intervention Type DEVICE

Individual lifestyle intervention via an mobile application

Group-based lifestyle intervention at the Healthy Lifestyle Centres

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

Group Type ACTIVE_COMPARATOR

Group-based lifestyle intervention

Intervention Type BEHAVIORAL

Group-based life style intervention at a Healthy Lifestyle Centre (ususal care)

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

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Interventions

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Mobile application

Individual lifestyle intervention via an mobile application

Intervention Type DEVICE

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

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

Intervention Type BEHAVIORAL

Group-based lifestyle intervention

Group-based life style intervention at a Healthy Lifestyle Centre (ususal care)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* smart phone
* prediabetes

Exclusion Criteria

* not interested in lifestyle change
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Birgitta Blakstad Nilsson, Phd

Role: PRINCIPAL_INVESTIGATOR

OsloMet

Locations

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OsloMet

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Birgitta Blakstad Nilsson, Phd

Role: CONTACT

+47 93210913

Gyri Skoglund, Msc

Role: CONTACT

+47 67 23 85 50

Other Identifiers

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887029

Identifier Type: -

Identifier Source: org_study_id

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