Time to Healthy Lifestyle Habit Using Digital Health Tools in Adults at Risk of Diabetes

Sponsor
Imam Abdulrahman Bin Faisal University
Study ID
NCT07667361
Status
Not Yet Recruiting

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Conditions

  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Hybrid digital intervention with personalized support. — OTHER
    12 Weeks
  • Standard lifestyle education — OTHER
    Standard lifestyle education for12 weeks

Study Details

1. 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. 2. 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. 3. 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). 4. Statistical Analysis 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

Key Dates

First listed
Jun 25, 2026
Start date
Jan 1, 2027
Status verified
Jun 2026
Primary completion
Dec 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
222 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group A
  • Active Comparator: Group B

Primary Outcome Measure

Time to Habit Adoption [ Time Frame: 12 weeks ]

Central Contacts

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