Lifestyle Management App for Adults With Diabetes Type (LIVEN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: interactive Mhealth Lifestyle behavior intervention; Other: Sham

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shaima A Alothman, PhD; Phone Number: +966503952053; Email: shaalothman@pnu.edu.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11321
    • Recruiting
    • Princess Nourah bint Abdulrahman University
    • Contact: Shaima A Alothman, PhD; Phone Number: +966503952053; Email: shaalothman@pnu.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
retention rates	reported as the number of participants completing all study sessions	immediately after the intervention (3 months)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Princess Nourah Bint Abdulrahman University
• Collaborators: Liven

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Type 2 diabetes management; Mhealth lifestyle management program
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 22-0140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No