Lifestyle Management App for Adults With Diabetes Type

Diabetes Mellitus, Type 2 Clinical Trial

— LIVEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05630508
• Other study ID #: 22-0140
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Princess Nourah Bint Abdulrahman University
• Contact: Shaima A Alothman, PhD
• Phone: +966503952053
• Email: shaalothman[@]pnu.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Other:
• Sham
Receiving standard care, LIVEN educational material and access to the application

Locations

Country	Name	City	State
Saudi Arabia	Princess Nourah bint Abdulrahman University	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
Princess Nourah Bint Abdulrahman University	Liven

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	retention rates	reported as the number of participants completing all study sessions	immediately after the intervention (3 months)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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