Lifestyle Management App for Adults With Diabetes Type

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

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-12-31

Brief Summary

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This study will evaluate whether the 12-week health coaching mobile application (LIVEN) will succeed in enhancing lifestyle behaviors in adults with Type 2 Diabetes compared to typical treatment. The mobile application's viability will be assessed in 2 parts; the first part is testing easiness and friendliness of using Liven by the patient and health coach. The second part is evaluating the suitability of Liven education material for the patients and whether the coaching program results in enhancing lifestyle behaviors and blood sugar levels. the investigators hypothesize that the 12-week online lifestyle-coaching program will be viable, and a full-scale study can proceed.

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Detailed Description

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This study will investigate the feasibility of a 12-weeks online lifestyle (nutrition and physical behavior) coaching program through a mobile app (LIVEN) compared to standard treatment for people with type 2 diabetes. This study will be done in two phases; the first phase is the usability study (phase1), in which the user friendliness of the application will be assessed, and any technical flaws will be resolved prior and during the second phase. The second phase of the study will consist of adapting a diabetes educational material and assessing the feasibility of the program (phase2). the investigators hypothesize that the 12-week online lifestyle-coaching program will be feasible, and a full-scale study can proceed.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to one of three groups in parallel for the duration of the study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

The participant won't know if they got the full or sham or no intervention

Study Groups

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interactive mhealth Lifestyle behavior intervention

Receiving Standard care, LIVEN educational material and interactive LIVEN application

Group Type EXPERIMENTAL

interactive Mhealth Lifestyle behavior intervention

Intervention Type BEHAVIORAL

Receiving Standard care, LIVEN educational material and interactive LIVEN application, via having a human component which is a health coach for 3 months

Sham group - app access only

Receiving standard care, LIVEN educational material and access to the application

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

Receiving standard care, LIVEN educational material and access to the application

Control group - Standard care

Receiving Standard care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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interactive Mhealth Lifestyle behavior intervention

Receiving Standard care, LIVEN educational material and interactive LIVEN application, via having a human component which is a health coach for 3 months

Intervention Type BEHAVIORAL

Sham

Receiving standard care, LIVEN educational material and access to the application

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults, aged 18 years or older
* Arabic speakers
* Capable of utilizing smartphones
* Diagnosed with T2DM
* Poor glycemic control: A1c \> 7.5%

Exclusion Criteria

* Individuals using insulin injection
* Individuals suffering from disorders that might affect intervention (e.g. amputation, enucleation of the eye, or end-stage kidney disease)
* Women who are pregnant or breastfeeding
* Individuals diagnosed with other types of diabetes (such as type I or MODY)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No