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Lifestyle Management App for Adults With Diabetes Type (LIVEN)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
interactive Mhealth Lifestyle behavior intervention
Sham
Sponsored by
Princess Nourah Bint Abdulrahman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes management, Mhealth lifestyle management program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Princess Nourah bint Abdulrahman UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

interactive mhealth Lifestyle behavior intervention

Sham group - app access only

Control group - Standard care

Arm Description

Receiving Standard care, LIVEN educational material and interactive LIVEN application

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

Receiving Standard care only

Outcomes

Primary Outcome Measures

recruitment rate - descriptive
reported as the number of participants' consented divide by the number of people that were invited to participate
retention rates
reported as the number of participants completing all study sessions
User friendliness
will be assessed via user engagement tracking in the app

Secondary Outcome Measures

Glycemic control - A1c
will be assess via A1c blood test will be reported as percentage. higher % indicate worse outcome
Glycemic control - continuous glucose mentoring (CGM)
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 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 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 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 via Sit to Stand Test (count), higher counts indicate higher physical performance
physical performance assessments - endurance
will be assessed via 6-minute walk test (distance in m). higher distance indicates higher endurance

Full Information

First Posted
October 10, 2022
Last Updated
November 18, 2022
Sponsor
Princess Nourah Bint Abdulrahman University
Collaborators
Liven
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1. Study Identification

Unique Protocol Identification Number
NCT05630508
Brief Title
Lifestyle Management App for Adults With Diabetes Type
Acronym
LIVEN
Official Title
mHealth Lifestyle Management Program (LIVEN) For Adults With Diabetes Type 2: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Nourah Bint Abdulrahman University
Collaborators
Liven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 diabetes management, Mhealth lifestyle management program

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of three groups in parallel for the duration of the study
Masking
Participant
Masking Description
The participant won't know if they got the full or sham or no intervention
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
interactive mhealth Lifestyle behavior intervention
Arm Type
Experimental
Arm Description
Receiving Standard care, LIVEN educational material and interactive LIVEN application
Arm Title
Sham group - app access only
Arm Type
Sham Comparator
Arm Description
Receiving standard care, LIVEN educational material and access to the application
Arm Title
Control group - Standard care
Arm Type
No Intervention
Arm Description
Receiving Standard care only
Intervention Type
Behavioral
Intervention Name(s)
interactive Mhealth Lifestyle behavior intervention
Intervention Description
Receiving Standard care, LIVEN educational material and interactive LIVEN application, via having a human component which is a health coach for 3 months
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Receiving standard care, LIVEN educational material and access to the application
Primary Outcome Measure Information:
Title
recruitment rate - descriptive
Description
reported as the number of participants' consented divide by the number of people that were invited to participate
Time Frame
immediately after the intervention (3 months)
Title
retention rates
Description
reported as the number of participants completing all study sessions
Time Frame
immediately after the intervention (3 months)
Title
User friendliness
Description
will be assessed via user engagement tracking in the app
Time Frame
Daily application engagement data for each patient will be analyzed once at the end of the patient's 12 week program.
Secondary Outcome Measure Information:
Title
Glycemic control - A1c
Description
will be assess via A1c blood test will be reported as percentage. higher % indicate worse outcome
Time Frame
will be assessed one week prior to the intervention and one week after the end of the intervention
Title
Glycemic control - continuous glucose mentoring (CGM)
Description
will be assess via continuous glucose mentoring (CGM) as variability. higher variability indicates worse outcome
Time Frame
will be assessed one week prior to the intervention and one week after the end of the intervention
Title
Body composition - fat free mass (%) physiological parameter
Description
will be assessed via Bioelectrical Impedance Analysis (BIA). fat free mass (%) will reported as percentage. higher % indicate better outcome
Time Frame
will be assessed one week prior to the intervention and one week after the end of the intervention
Title
Lifestyle behaviors - Health-Promoting Lifestyle profile II (Questionnaire)
Description
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.
Time Frame
will be assessed one week prior to the intervention and one week after the end of the intervention
Title
physical performance assessments - upper body muscle strength in kg
Description
will be assessed via Hand Grip Strength using dynameter (power in kg), higher scores indicate higher physical performance
Time Frame
will be assessed one week prior to the intervention and one week after the end of the intervention
Title
physical performance assessments - lower body muscle strength in counts
Description
will be assessed via Sit to Stand Test (count), higher counts indicate higher physical performance
Time Frame
will be assessed one week prior to the intervention and one week after the end of the intervention
Title
physical performance assessments - endurance
Description
will be assessed via 6-minute walk test (distance in m). higher distance indicates higher endurance
Time Frame
will be assessed one week prior to the intervention and one week after the end of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaima A Alothman, PhD
Phone
+966503952053
Email
shaalothman@pnu.edu.sa
Facility Information:
Facility Name
Princess Nourah bint Abdulrahman University
City
Riyadh
ZIP/Postal Code
11321
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaima A Alothman, PhD
Phone
+966503952053
Email
shaalothman@pnu.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Lifestyle Management App for Adults With Diabetes Type

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