Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07667361
Enrollment
222
Registered
2026-06-25
Start date
2027-01-01
Completion date
2028-06-30
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes

Keywords

life style habits, prediabetis, time to habit formation

Brief summary

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

Interventions

OTHERHybrid digital intervention with personalized support.

12 Weeks

Standard lifestyle education for12 weeks

Sponsors

Imam Abdulrahman Bin Faisal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Adults(18-65 years) Risk of Diabetis

Exclusion criteria

* Dignosed diabetis Pregnancy Any other contraindication to exericse praticipation

Design outcomes

Primary

MeasureTime frame
Time to Habit Adoption12 weeks

Contacts

CONTACTShibili Nuhmani, PhD
snuhmani@iau.edu.sa00966554270531

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026