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Recruiting NCT05630508

Lifestyle Management App for Adults With Diabetes Type

No phase Interventional Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: interactive Mhealth Lifestyle behavior intervention, Sham.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • recruitment rate - descriptive [Time frame: immediately after the intervention (3 months)]
  • retention rates [Time frame: immediately after the intervention (3 months)]
  • 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.]
Secondary outcome measures (7)
  • Glycemic control - A1c [Time frame: will be assessed one week prior to the intervention and one week after the end of the intervention]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • physical performance assessments - endurance [Time frame: will be assessed one week prior to the intervention and one week after the end of the intervention]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Saudi Arabia · 1 center
  • Princess Nourah bint Abdulrahman University — Riyadh

Identifiers

NCT: NCT05630508 · 22-0140

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗