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

June 18, 2026 updated by: Shibili Nuhmani, Imam Abdulrahman Bin Faisal University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults(18-65 years) Risk of Diabetis

Exclusion Criteria:

  • Dignosed diabetis Pregnancy Any other contraindication to exericse praticipation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Other: Hybrid digital intervention with personalized support.
12 Weeks
Active Comparator: Group B
Other: Standard lifestyle education
Standard lifestyle education for12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Habit Adoption
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imam Abdulrahman Bin Faisal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2026-03-0383

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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