PrediabetesNCT07667361
Time to Healthy Lifestyle Habit Using Digital Health Tools in Adults at Risk of Diabetes
A study testing Hybrid digital intervention with personalized support. and Standard lifestyle education in people with Prediabetes, run by Imam Abdulrahman Bin Faisal University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Hybrid digital intervention with personalized support. and Standard lifestyle education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults(18-65 years) Risk of Diabetis
Who cannot join
- Dignosed diabetis Pregnancy Any other contraindication to exericse praticipation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Time to Healthy Lifestyle Habit Using Digital Health Tools in Adults at Risk of Diabetes: A Randomized Clinical Trial With Time-to-Habit Analysis
- 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.
- 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.
- 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).
- 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
- Conditions
- Prediabetes
- Being tested
- Hybrid digital intervention with personalized support., Standard lifestyle education
- Keywords
- life style habits, prediabetis, time to habit formation
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid digital intervention with personalized support.Other
12 Weeks
Standard lifestyle educationOther
Standard lifestyle education for12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Other: Hybrid digital intervention with personalized support. |
| Group B | Active comparator | Not described Receives: Other: Standard lifestyle education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Habit Adoption
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shibili Nuhmani, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667361
- Sponsor's protocol ID
- IRB-2026-03-0383
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Healthy Lifestyle Habit Using Digital Health Tools in Adults at Risk of Diabetes: A Randomized Clinical Trial With Time-to-Habit Analysis
- ClinicalTrials.gov ID
- NCT07667361
- Acronym / sponsor ID
- IRB-2026-03-0383
- Conditions
- Prediabetes
- Keywords
- life style habits, prediabetis, time to habit formation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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).
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Hybrid digital intervention with personalized support. |
| Group B | Active comparator | Other: Standard lifestyle education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults(18-65 years) Risk of Diabetis
Key exclusion criteria (1 listed)
- Dignosed diabetis Pregnancy Any other contraindication to exericse praticipation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid digital intervention with personalized support.12 Weeks | Other | Group A |
| Standard lifestyle educationStandard lifestyle education for12 weeks | Other | Group B |
Primary outcome
Time to Habit Adoption
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid digital intervention with personalized support. and Standard lifestyle education in people with Prediabetes, run by Imam Abdulrahman Bin Faisal University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shibili Nuhmani, PhD (00966554270531, snuhmani@iau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Habit Adoption (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.