Clinical trial NCT05630508: Lifestyle Management App for Adults With Diabetes Type
Official title: mHealth Lifestyle Management Program (LIVEN) For Adults With Diabetes Type 2: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes management
Mhealth lifestyle management program
Lead sponsor: Princess Nourah Bint Abdulrahman University
Sponsor class: OTHER
Collaborators: name: Liven
First posted: 2022-11-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of three groups in parallel for the duration of the study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: recruitment rate - descriptive
timeFrame: immediately after the intervention (3 months)
measure: retention rates
timeFrame: immediately after the intervention (3 months)
measure: User friendliness
timeFrame: Daily application engagement data for each patient will be analyzed once at the end of the patient's 12 week program.
Secondary outcomes:
measure: Glycemic control - A1c
timeFrame: will be assessed one week prior to the intervention and one week after the end of the intervention
measure: Glycemic control - continuous glucose mentoring (CGM)
timeFrame: will be assessed one week prior to the intervention and one week after the end of the intervention
measure: Body composition - fat free mass (%) physiological parameter
timeFrame: will be assessed one week prior to the intervention and one week after the end of the intervention
measure: Lifestyle behaviors - Health-Promoting Lifestyle profile II (Questionnaire)
timeFrame: will be assessed one week prior to the intervention and one week after the end of the intervention
measure: physical performance assessments - upper body muscle strength in kg
timeFrame: will be assessed one week prior to the intervention and one week after the end of the intervention
measure: physical performance assessments - lower body muscle strength in counts
timeFrame: will be assessed one week prior to the intervention and one week after the end of the intervention
measure: physical performance assessments - endurance
timeFrame: will be assessed one week prior to the intervention and one week after the end of the intervention
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Princess Nourah bint Abdulrahman University
Study officials:
References: