Lifestyle Management App for Adults With Diabetes Type (LIVEN)

Princess Nourah Bint Abdulrahman University

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: interactive Mhealth Lifestyle behavior intervention; Other: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT05630508

22-0140

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

interactive mhealth Lifestyle behavior intervention

Experimental group

Description:

Receiving Standard care, LIVEN educational material and interactive LIVEN application

Treatment:

Behavioral: interactive Mhealth Lifestyle behavior intervention

Sham group - app access only

Sham Comparator group

Description:

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

Treatment:

Other: Sham

Control group - Standard care

No Intervention group

Description:

Receiving Standard care only