Time to Healthy Lifestyle Habit Using Digital Health Tools in Adults at Risk of Diabetes: A Randomized Clinical Trial With Time-to-Habit Analysis

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