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NCT Number: NCT05630508

Lifestyle Management App for Adults With Diabetes Type

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Nourah bint Abdulrahman University

Riyadh, Riyadh Region, 11321, Saudi Arabia

Location status: Recruiting

Location contact

Shaima A Alothman, PhD

CONTACT

[email protected]

+966503952053

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

SHAM

Other

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

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Shaima A Alothman, PhD

CONTACT

[email protected]

+966503952053

Sponsors and collaborators

Lead sponsor

Princess Nourah Bint Abdulrahman University

Other

Collaborators

  • Liven

Registry information

Official study title

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

Acronym: LIVEN

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2022
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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