An interventional study of Hybrid digital intervention with personalized support. and Standard lifestyle education in Prediabetes, sponsored by Imam Abdulrahman Bin Faisal University. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Imam Abdulrahman Bin Faisal University · Not applicable, Interventional, and Prevention
Background \& Context
The Challenge: Type 2 Diabetes (T2D) is a major public health burden. Lifestyle changes are effective, but little is known about how long it actually takes to make these changes stick.
The Gap: Traditional trials look at outcomes at fixed time points (e.g., 12 weeks). We lack data on the specific timeline of habit formation, which is critical for designing scalable interventions.
The Setting: This study aligns with Saudi Vision 2030 by leveraging digital health to improve population wellness.
Study Objectives
Primary Aim: To determine if a structured digital intervention accelerates the time to habit adoption compared to standard education.
Secondary Aims: To measure improvements in glucose control (HbA1c), overall physical activity levels, and quality of life.
Study Design \& Methods
Design: Randomized Controlled Trial (RCT).
Population: 222 adults at risk for diabetes.
Intervention (12 Weeks):
Group A (Experimental): Hybrid digital intervention with personalized support.
Group B (Control): Standard lifestyle education.
Follow-up: Total study duration of 24 weeks.
Primary Endpoint: "Time to Habit." Defined as achieving ≥150 min/week of moderate-to-vigorous physical activity (MVPA) for four consecutive weeks (verified by wearables).
Primary Analysis: We will use Kaplan-Meier curves to visualize the probability of achieving the habit over time, and Cox Proportional Hazards models to calculate the "Hazard Ratio" (the speed of adoption between the two groups).
Secondary Analysis: General linear models for continuous outcomes (HbA1c, IPAQ, SF-12
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 222 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Imam Abdulrahman Bin Faisal University is the lead sponsor of 91 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Hybrid digital intervention with personalized support.
Other: Standard lifestyle education
12 Weeks
Standard lifestyle education for12 weeks
Time to Habit Adoption
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2027, 11 months later.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 11 months is below that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Imam Abdulrahman Bin Faisal University