Lifestyle Management App for Adults With Diabetes Type

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Sham; Behavioral: interactive Mhealth Lifestyle behavior intervention

• Registration Number: NCT05630508
• Lead Sponsor: Princess Nourah Bint Abdulrahman University

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.

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-11-18
• Study First Posted: 2022-11-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Adults, aged 18 years or older
• Arabic speakers
• Capable of utilizing smartphones
• Diagnosed with T2DM
• Poor glycemic control: A1c > 7.5%

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham group - app access only	Sham	Receiving standard care, LIVEN educational material and access to the application
interactive mhealth Lifestyle behavior intervention	interactive Mhealth Lifestyle behavior intervention	Receiving Standard care, LIVEN educational material and interactive LIVEN application

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Princess Nourah bint Abdulrahman University; 🇸🇦 Riyadh, Saudi Arabia