LIVEN: Lifestyle Management App for Adults With Diabetes Type
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: interactive mhealth Lifestyle behavior intervention Receiving Standard care, LIVEN educational material and interactive LIVEN application |
Behavioral: interactive Mhealth Lifestyle behavior intervention
Receiving Standard care, LIVEN educational material and interactive LIVEN application, via having a human component which is a health coach for 3 months
|
| Sham Comparator: Sham group - app access only Receiving standard care, LIVEN educational material and access to the application |
Other: Sham
Receiving standard care, LIVEN educational material and access to the application
|
| No Intervention: Control group - Standard care Receiving Standard care only |
Outcome Measures
Primary Outcome Measures
- recruitment rate - descriptive [immediately after the intervention (3 months)]
reported as the number of participants' consented divide by the number of people that were invited to participate
- retention rates [immediately after the intervention (3 months)]
reported as the number of participants completing all study sessions
- User friendliness [Daily application engagement data for each patient will be analyzed once at the end of the patient's 12 week program.]
will be assessed via user engagement tracking in the app
Secondary Outcome Measures
- Glycemic control - A1c [will be assessed one week prior to the intervention and one week after the end of the intervention]
will be assess via A1c blood test will be reported as percentage. higher % indicate worse outcome
- Glycemic control - continuous glucose mentoring (CGM) [will be assessed one week prior to the intervention and one week after the end of the intervention]
will be assess via continuous glucose mentoring (CGM) as variability. higher variability indicates worse outcome
- Body composition - fat free mass (%) physiological parameter [will be assessed one week prior to the intervention and one week after the end of the intervention]
will be assessed via Bioelectrical Impedance Analysis (BIA). fat free mass (%) will reported as percentage. higher % indicate better outcome
- Lifestyle behaviors - Health-Promoting Lifestyle profile II (Questionnaire) [will be assessed one week prior to the intervention and one week after the end of the intervention]
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.
- physical performance assessments - upper body muscle strength in kg [will be assessed one week prior to the intervention and one week after the end of the intervention]
will be assessed via Hand Grip Strength using dynameter (power in kg), higher scores indicate higher physical performance
- physical performance assessments - lower body muscle strength in counts [will be assessed one week prior to the intervention and one week after the end of the intervention]
will be assessed via Sit to Stand Test (count), higher counts indicate higher physical performance
- physical performance assessments - endurance [will be assessed one week prior to the intervention and one week after the end of the intervention]
will be assessed via 6-minute walk test (distance in m). higher distance indicates higher endurance
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Princess Nourah bint Abdulrahman University | Riyadh | Saudi Arabia | 11321 |
Sponsors and Collaborators
- Princess Nourah Bint Abdulrahman University
- Liven
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-0140