An interventional study of interactive Mhealth Lifestyle behavior intervention and Sham in Diabetes Mellitus, Type 2, sponsored by Princess Nourah Bint Abdulrahman University. Recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Princess Nourah Bint Abdulrahman University · Not applicable, Interventional, and Supportive care
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Princess Nourah Bint Abdulrahman University is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Receiving Standard care, LIVEN educational material and interactive LIVEN application
Behavioral: interactive Mhealth Lifestyle behavior intervention
Receiving standard care, LIVEN educational material and access to the application
Other: Sham
Receiving Standard care only
Receiving Standard care, LIVEN educational material and interactive LIVEN application, via having a human component which is a health coach for 3 months
Receiving standard care, LIVEN educational material and access to the application
recruitment rate - descriptive
reported as the number of participants' consented divide by the number of people that were invited to participate
Time frame: immediately after the intervention (3 months)
retention rates
reported as the number of participants completing all study sessions
Time frame: immediately after the intervention (3 months)
User friendliness
will be assessed via user engagement tracking in the app
Time frame: Daily application engagement data for each patient will be analyzed once at the end of the patient's 12 week program.
Glycemic control - A1c
will be assess via A1c blood test will be reported as percentage. higher % indicate worse outcome
Time frame: 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
Time frame: 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
Time frame: will be assessed one week prior to the intervention and one week after the end of the intervention
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: will be assessed one week prior to the intervention and one week after the end of the intervention
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Princess Nourah Bint Abdulrahman University