Type 2 Diabetes Risk Reduction in Young AdultsNCT07604012
Holistic Lifestyle mHealth Intervention for Risk Reduction of Type 2 Diabetes Mellitus in Young Adults
A study testing Holistic mHealth Intervention in people with Type 2 Diabetes Risk Reduction in Young Adults, run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial (randomized controlled trial) is to examine the effectiveness of a holistic lifestyle mHealth intervention in reducing the risk of type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Risk Reduction in Young Adults
- What is being tested?
- Holistic mHealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to 30 Dec 2026
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young adults aged between 20-35 years, as defined by the WHO.
- At risk of diabetes based on self-reported family history or lifestyle habits.
- Participants who are willing to engage in the mHealth intervention program.
- Own a smartphone and are familiar with using mobile apps.
- Complete the informed consent process, agreeing to follow the study protocol, including survey completion and health assessment.
Who cannot join
- Individuals diagnosed with chronic mental or physical illnesses
- Individuals with hearing or vision loss so severe that they could not access the mobile health intervention.
- Pregnant women or women who plan on becoming pregnant during the study.
- Individuals who are already taking part in an equivalent diabetes or health programme.
- Individuals who are not willing to provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Holistic Lifestyle mHealth Intervention for Risk Reduction of Type 2 Diabetes Mellitus in Young Adults: A Randomized Controlled Trial
The goal of this clinical trial (randomized controlled trial) is to examine the effectiveness of a holistic lifestyle mHealth intervention in reducing the risk of type 2 diabetes mellitus.
The study focuses on young adults aged 20-35 years, recruited from public and private universities in Rawalpindi and Islamabad, who meet the defined inclusion criteria.
The main questions it aims to answer are:
Does a holistic lifestyle mHealth intervention significantly reduce the risk of type 2 diabetes ? Does the intervention improve overall health-related quality of life and lifestyle behaviors, including diet, physical activity, and stress management?
Read the detailed description
Researchers will compare participants receiving the holistic lifestyle mHealth intervention (based on "Eat Well, Move More, Stress Less") with a control group receiving standard care or basic health guidance to see if the intervention leads to greater reduction in diabetes risk and improved health outcomes.
Participants will:
Use a culturally tailored mHealth application designed for the Pakistani context Follow lifestyle recommendations focused on diet, physical activity, and stress management Engage with intervention content based on the three core pillars: Eat Well, Move More, Stress Less Participate in periodic assessments, including health measurements and questionnaires Provide feedback on their experience and adherence to the intervention
- Being tested
- Holistic mHealth Intervention
- Keywords
- Holistic Lifestyle, mHealth, Randomized Controlled Trial, Diabetes Mellitus, Type 2 Diabetes, Lifestyle, Diabetes Risk reduction, Lifestyle Intervention, Food Literacy, Eating Behavior, Physical Activity, Stress Management, Sleep Qaulity
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holistic mHealth InterventionBehavioural
Also called mHealth App, mhealth Intervention, Holistic Intervention
The main components of the holistic mHealth intervention include the following: nutritional education, promotion of physical activity, sleep education, and behavioral health support. The integration of these components in mHealth promotes a holistic lifestyle through enhancing overall health-related quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Holistic mHealth Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved quality of Life
Measured using a validated tool, the Short Form Health Survey (SF-36), assessed at baseline and post-intervention. The primary endpoint is the difference in mean risk scores between the intervention and control groups.
score ≤ 44 indicates weak, 45-63 indicate medium, ≥ 64 indicate good.
Measured: 6-8 weeks
Secondary outcomes (6)
Secondary outcome measures include changes in blood glucose level
Diabetes risk assessment is assessed through RAPID (Risk Assessment of Pakistani Individual for Diabetes) .
Changes in blood glucose levels assessd through HbA1c measured in mg/dL at baseline and post-intervention.
Measured: 8 weeks
Food literacy
Food literacy measured by using Self-Perceived Food Literacy Scale Short Form Scoing : <30.6 indicates inadequate-limited food literacy; >31 indicates adequate-excellent food literacy.
Measured: 8 weeks
Eating Behavior
Eating Behavior measured by using Self-Regulation of Eating Behavior Questionnaire for Adults. Scoring: <2.8 indicate Low level, 2.8 to 3.6 indicate Medium>3.6High
Measured: 8 weeks
Physical Health
weight will be combined to report BMI in kg/m^2.
Measured: 8 weeks
sleep quality
Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI) Scoring
:0 - No sleep difficulties; 5 or higher - Poor sleep quality
Measured: 8 weeks
Psychological Distress
Psychological Distress will be measured by using Depression, Anxiety and Stress Scale (DASS-21)
Scoring:
Depression : 0-9 normal ,14-20 moderate , 28+ severe Anxiety : 8-9 mild , 10-14 moderate Stress: 15-18 mild, 19-25 moderate
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Risk Reduction in Young AdultsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anmol Ayaz, Fatima Jinnah Women University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604012
- Sponsor's protocol ID
- JinnahUW
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-dentified participant data underlying the published results may be made available upon reasonable request. Shared data may include demographic variables, outcome measures, and analyzable datasets relevant to the study objectives. Data requests may be submitted to the principal investigator. Access will be considered for researchers with methodologically sound proposals and subject to institutional ethical approval and data use agreements.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Holistic Lifestyle mHealth Intervention for Risk Reduction of Type 2 Diabetes Mellitus in Young Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07604012
- Acronym / sponsor ID
- JinnahUW
- Keywords
- Holistic Lifestyle, mHealth, Randomized Controlled Trial, Diabetes Mellitus, Type 2 Diabetes, Lifestyle, Diabetes Risk reduction, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 May 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.
The goal of this clinical trial (randomized controlled trial) is to examine the effectiveness of a holistic lifestyle mHealth intervention in reducing the risk of type 2 diabetes mellitus.
The study focuses on young adults aged 20-35 years, recruited from public and private universities in Rawalpindi and Islamabad, who meet the defined inclusion criteria.
The main questions it aims to answer are:
Does a holistic lifestyle mHealth intervention significantly reduce the risk of type 2 diabetes ? Does the intervention improve overall health-related quality of life and lifestyle behaviors, including diet, physical activity, and stress management?
Detailed description
Researchers will compare participants receiving the holistic lifestyle mHealth intervention (based on "Eat Well, Move More, Stress Less") with a control group receiving standard care or basic health guidance to see if the intervention leads to greater reduction in diabetes risk and improved health outcomes.
Participants will:
Use a culturally tailored mHealth application designed for the Pakistani context Follow lifestyle recommendations focused on diet, physical activity, and stress management Engage with intervention content based on the three core pillars: Eat Well, Move More, Stress Less Participate in periodic assessments, including health measurements and questionnaires Provide feedback on their experience and adherence to the intervention
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Holistic mHealth Intervention |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Young adults aged between 20-35 years, as defined by the WHO.
- At risk of diabetes based on self-reported family history or lifestyle habits.
- Participants who are willing to engage in the mHealth intervention program.
- Own a smartphone and are familiar with using mobile apps.
- Complete the informed consent process, agreeing to follow the study protocol, including survey completion and health assessment.
Key exclusion criteria (5 listed)
- Individuals diagnosed with chronic mental or physical illnesses
- Individuals with hearing or vision loss so severe that they could not access the mobile health intervention.
- Pregnant women or women who plan on becoming pregnant during the study.
- Individuals who are already taking part in an equivalent diabetes or health programme.
- Individuals who are not willing to provide consent.
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 |
|---|---|---|
| Holistic mHealth InterventionAlso: mHealth App, mhealth Intervention, Holistic InterventionThe main components of the holistic mHealth intervention include the following: nutritional education, promotion of physical activity, sleep education, and behavioral health support. The integration of these components in mHealth promotes a holistic lifestyle through enhancing overall health-related quality of life. | Behavioural | Intervention Group |
Primary outcome
Improved quality of Life
Time frame: 6-8 weeks
Measured using a validated tool, the Short Form Health Survey (SF-36), assessed at baseline and post-intervention. The primary endpoint is the difference in mean risk scores between the intervention and control groups. score ≤ 44 indicates weak, 45-63 indicate medium, ≥ 64 indicate good.
6 secondary outcomes
Secondary outcome measures include changes in blood glucose level
Time frame: 8 weeks
Food literacy
Time frame: 8 weeks
Eating Behavior
Time frame: 8 weeks
Physical Health
Time frame: 8 weeks
sleep quality
Time frame: 8 weeks
Psychological Distress
Time frame: 8 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 22 May 2026.
- Individual participant dataSharing planned: Yes. De-dentified participant data underlying the published results may be made available upon reasonable request. Shared data may include demographic variables, outcome measures, and analyzable datasets relevant to the study objectives. Data requests may be submitted to the principal investigator. Access will be considered for researchers with methodologically sound proposals and subject to institutional ethical approval and data use agreements.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holistic mHealth Intervention in people with Type 2 Diabetes Risk Reduction in Young Adults, run by Fatima Jinnah Women University at 1 site in Pakistan.
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 5 inclusion and 5 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Anmol Ayaz, Phd Scholar (923335791127, anmol.ayaz@fjwu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved quality of Life (time frame: 6-8 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 22 May 2026.