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
Exclusion Criteria:
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.
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