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Lifestyle Management App for Adults With Diabetes Type (LIVEN)

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ClinicalTrials.gov Identifier: NCT05630508
Recruitment Status : Recruiting
First Posted : November 29, 2022
Last Update Posted : November 29, 2022
Sponsor:
Collaborator:
Liven
Information provided by (Responsible Party):
Shaima Alothman, Princess Nourah Bint Abdulrahman University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: interactive Mhealth Lifestyle behavior intervention Other: Sham Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of three groups in parallel for the duration of the study
Masking: Single (Participant)
Masking Description: The participant won't know if they got the full or sham or no intervention
Primary Purpose: Supportive Care
Official Title: mHealth Lifestyle Management Program (LIVEN) For Adults With Diabetes Type 2: A Feasibility Study
Actual Study Start Date : October 1, 2022
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. recruitment rate - descriptive [ Time Frame: immediately after the intervention (3 months) ]
    reported as the number of participants' consented divide by the number of people that were invited to participate

  2. retention rates [ Time Frame: immediately after the intervention (3 months) ]
    reported as the number of participants completing all study sessions

  3. User friendliness [ Time Frame: 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 :
  1. Glycemic control - A1c [ Time Frame: 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

  2. Glycemic control - continuous glucose mentoring (CGM) [ Time Frame: 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

  3. Body composition - fat free mass (%) physiological parameter [ Time Frame: 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

  4. Lifestyle behaviors - Health-Promoting Lifestyle profile II (Questionnaire) [ Time Frame: 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.

  5. physical performance assessments - upper body muscle strength in kg [ Time Frame: 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

  6. physical performance assessments - lower body muscle strength in counts [ Time Frame: 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

  7. physical performance assessments - endurance [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05630508


Contacts
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Contact: Shaima A Alothman, PhD +966503952053 shaalothman@pnu.edu.sa

Locations
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Saudi Arabia
Princess Nourah bint Abdulrahman University Recruiting
Riyadh, Saudi Arabia, 11321
Contact: Shaima A Alothman, PhD    +966503952053    shaalothman@pnu.edu.sa   
Sponsors and Collaborators
Princess Nourah Bint Abdulrahman University
Liven
More Information
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Responsible Party: Shaima Alothman, Research Scientist, Clinical Assistant Professor, Princess Nourah Bint Abdulrahman University
ClinicalTrials.gov Identifier: NCT05630508    
Other Study ID Numbers: 22-0140
First Posted: November 29, 2022    Key Record Dates
Last Update Posted: November 29, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shaima Alothman, Princess Nourah Bint Abdulrahman University:
Type 2 diabetes management
Mhealth lifestyle management program
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases