Lifestyle Management App for Adults With Diabetes Type

NCT05630508 | Recruiting

• 1 other identifier: 22-0140
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes management; Mhealth lifestyle management program

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Glycemic control - A1c

  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 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 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 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 one week prior to the intervention and one week after the end of the intervention

Study Arms (3)

interactive mhealth Lifestyle behavior intervention

EXPERIMENTAL

Receiving Standard care, LIVEN educational material and interactive LIVEN application

Behavioral: interactive Mhealth Lifestyle behavior intervention

Sham group - app access only

SHAM COMPARATOR

Receiving standard care, LIVEN educational material and access to the application

Other: Sham

Control group - Standard care

NO INTERVENTION

Receiving Standard care only

Interventions

interactive Mhealth Lifestyle behavior intervention BEHAVIORAL

Receiving Standard care, LIVEN educational material and interactive LIVEN application, via having a human component which is a health coach for 3 months

interactive mhealth Lifestyle behavior intervention

Sham OTHER

Receiving standard care, LIVEN educational material and access to the application

Sham group - app access only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Princess Nourah Bint Abdulrahman University: lead
• Liven: collaborator

Study Sites (1)

Princess Nourah bint Abdulrahman University

Riyadh, Riyadh Region, 11321, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Shaima A Alothman, PhD

CONTACT

+966503952053; shaalothman@pnu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant won't know if they got the full or sham or no intervention
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist, Clinical Assistant Professor

Model Details: Participants are assigned to one of three groups in parallel for the duration of the study

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: November 29, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

SA (1)