Lifestyle Management App for Adults With Diabetes Type

Study Overview
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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.

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.

Official Title
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mHealth Lifestyle Management Program (LIVEN) For Adults With Diabetes Type 2: A Feasibility Study

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: interactive Mhealth Lifestyle behavior intervention
* Other: Sham


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of three groups in parallel for the duration of the study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interactive mhealth Lifestyle behavior intervention<br>Receiving Standard care, LIVEN educational material and interactive LIVEN application | Behavioral: interactive Mhealth Lifestyle behavior intervention<br>* Receiving Standard care, LIVEN educational material and interactive LIVEN application, via having a human component which is a health coach for 3 months<br>|
| Sham Comparator: Sham group - app access only<br>Receiving standard care, LIVEN educational material and access to the application | Other: Sham<br>* Receiving standard care, LIVEN educational material and access to the application<br>|
| No Intervention: Control group - Standard care<br>Receiving Standard care only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recruitment rate - descriptive | reported as the number of participants' consented divide by the number of people that were invited to participate | immediately after the intervention (3 months) | 
| retention rates | reported as the number of participants completing all study sessions | immediately after the intervention (3 months) | 
| User friendliness | will be assessed via user engagement tracking in the app | Daily application engagement data for each patient will be analyzed once at the end of the patient's 12 week program. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifestyle behaviors - Health-Promoting Lifestyle profile II (Questionnaire) | will be assessed via Health-Promoting Lifestyle profile II. HPLP-II is a 4-point Likert scale with 52 items including six subscales: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relationships, and stress management. scores range from 52 to 208. higher scores indicate better outcome. | will be assessed one week prior to the intervention and one week after the end of the intervention | 
| physical performance assessments - upper body muscle strength in kg | will be assessed via Hand Grip Strength using dynameter (power in kg), higher scores indicate higher physical performance | will be assessed one week prior to the intervention and one week after the end of the intervention | 
| physical performance assessments - lower body muscle strength in counts | will be assessed via Sit to Stand Test (count), higher counts indicate higher physical performance | will be assessed one week prior to the intervention and one week after the end of the intervention | 
| physical performance assessments - endurance | will be assessed via 6-minute walk test (distance in m). higher distance indicates higher endurance | will be assessed one week prior to the intervention and one week after the end of the intervention | 
| Glycemic control - continuous glucose mentoring (CGM) | will be assess via continuous glucose mentoring (CGM) as variability. higher variability indicates worse outcome | will be assessed one week prior to the intervention and one week after the end of the intervention | 
| Body composition - fat free mass (%) physiological parameter | will be assessed via Bioelectrical Impedance Analysis (BIA). fat free mass (%) will reported as percentage. higher % indicate better outcome | will be assessed one week prior to the intervention and one week after the end of the intervention | 
| Glycemic control - A1c | will be assess via A1c blood test will be reported as percentage. higher % indicate worse outcome | will be assessed one week prior to the intervention and one week after the end of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes management, Mhealth lifestyle management program