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Not yet recruitingNCT07667361Updated Jun 25, 2026

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
222
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Prediabetes

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Keywords

  • life style habits
  • prediabetis
  • time to habit formation
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adults(18-65 years) Risk of Diabetis

Exclusion criteria

Exclusion Criteria:

  • Dignosed diabetis Pregnancy Any other contraindication to exericse praticipation
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
222 participants (estimated)

Study arms

  • Experimental
    Group A

    Other: Hybrid digital intervention with personalized support.

  • Active comparator
    Group B

    Other: Standard lifestyle education

Interventions

  • OtherHybrid digital intervention with personalized support.

    12 Weeks

  • OtherStandard lifestyle education

    Standard lifestyle education for12 weeks

05

What researchers measure

Primary outcomes

  1. Time to Habit Adoption

    Time frame: 12 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07667361
Lead sponsor
Imam Abdulrahman Bin Faisal University
Responsible party
Shibili Nuhmani (Assistant Professor, Imam Abdulrahman Bin Faisal University) — Principal investigator
First posted
Jun 25, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Dec 30, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Jun 25, 2026

Study contacts

Shibili Nuhmani, PhD
Contact
snuhmani@iau.edu.sa
00966554270531

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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