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Diabetes Mellitus, Type 2LIVENNCT05630508

Lifestyle Management App for Adults With Diabetes Type

A study testing interactive Mhealth Lifestyle behavior intervention in people with Diabetes Mellitus, Type 2, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
interactive Mhealth Lifestyle behavior intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteSaudi Arabia
Study dates
1 Oct 2022to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shaima A Alothman, PhD contact

+966503952053

shaalothman@pnu.edu.sa

Saudi Arabia1 site, 1 recruiting

  • Princess Nourah bint Abdulrahman University

    Riyadh, Riyadh Region, 11321

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

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: 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.

Read the 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.

Being tested
interactive Mhealth Lifestyle behavior intervention, Sham
Keywords
Type 2 diabetes management, Mhealth lifestyle management program
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • interactive Mhealth Lifestyle behavior interventionBehavioural

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

  • ShamOther

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

Study groups in NCT05630508
Study groupRoleWhat they receive
interactive mhealth Lifestyle behavior interventionExperimentalReceiving Standard care, LIVEN educational material and interactive LIVEN application
Receives: Behavioral: interactive Mhealth Lifestyle behavior intervention
Sham group - app access onlySham comparatorReceiving standard care, LIVEN educational material and access to the application
Receives: Other: Sham
Control group - Standard careNo interventionReceiving Standard care only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. recruitment rate - descriptive

    reported as the number of participants' consented divide by the number of people that were invited to participate

    Measured: immediately after the intervention (3 months)

  2. retention rates

    reported as the number of participants completing all study sessions

    Measured: immediately after the intervention (3 months)

  3. User friendliness

    will be assessed via user engagement tracking in the app

    Measured: Daily application engagement data for each patient will be analyzed once at the end of the patient's 12 week program.

Secondary outcomes (7)

  1. Glycemic control - A1c

    will be assess via A1c blood test will be reported as percentage. higher % indicate worse outcome

    Measured: will be assessed one week prior to the intervention and one week after the end of the intervention

  2. Glycemic control - continuous glucose mentoring (CGM)

    will be assess via continuous glucose mentoring (CGM) as variability. higher variability indicates worse outcome

    Measured: will be assessed one week prior to the intervention and one week after the end of the intervention

  3. 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

    Measured: will be assessed one week prior to the intervention and one week after the end of the intervention

  4. 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.

    Measured: will be assessed one week prior to the intervention and one week after the end of the intervention

  5. 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

    Measured: will be assessed one week prior to the intervention and one week after the end of the intervention

  6. physical performance assessments - lower body muscle strength in counts

    will be assessed via Sit to Stand Test (count), higher counts indicate higher physical performance

    Measured: will be assessed one week prior to the intervention and one week after the end of the intervention

  7. physical performance assessments - endurance

    will be assessed via 6-minute walk test (distance in m). higher distance indicates higher endurance

    Measured: will be assessed one week prior to the intervention and one week after the end of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2022
  2. Study start1 Oct 2022
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are assigned to one of three groups in parallel for the duration of the study
Masking
Single blind
Who is masked
Participant
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05630508
Sponsor's protocol ID
22-0140
Acronym
LIVEN
Status last verified
Jun 2025
First submitted
10 Oct 2022
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing interactive Mhealth Lifestyle behavior intervention in people with Diabetes Mellitus, Type 2, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shaima A Alothman, PhD (+966503952053, shaalothman@pnu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recruitment rate - descriptive (time frame: immediately after the intervention (3 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05630508.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.

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