Lifestyle Management App for Adults With Diabetes Type
ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrincess Nourah Bint Abdulrahman University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults, aged 18 years or older
Arabic speakers
Capable of utilizing smartphones
Diagnosed with T2DM
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
interactive Mhealth Lifestyle behavior intervention
BehavioralReceiving Standard care, LIVEN educational material and interactive LIVEN application, via having a human component which is a health coach for 3 months
Sham
Other interventionReceiving standard care, LIVEN educational material and access to the application
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: interactive mhealth Lifestyle behavior interventionExperimental treatment 1 intervention
Group B: Sham group - app access onlySham comparator 1 intervention
Group C: Control group - Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)2
retention rates
reported as the number of participants completing all study sessions
Time frame
immediately after the intervention (3 months)3
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.Secondary outcomes
1
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 intervention2
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 intervention3
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 intervention4
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Princess Nourah Bint Abdulrahman University
Lead sponsor
Liven
Collaborator
Source ClinicalTrials.gov