An interventional study of Holistic mHealth Intervention in Type 2 Diabetes Risk Reduction in Young Adults, sponsored by Fatima Jinnah Women University. Not yet recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Fatima Jinnah Women University · Not applicable, Interventional, and Prevention
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?
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
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Fatima Jinnah Women University is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Compared within Diabetes Mellitus, Type 2, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Holistic mHealth 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.
Also known as: mHealth App, mhealth Intervention, Holistic Intervention
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.
Time frame: 6-8 weeks
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.
Time frame: 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.
Time frame: 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
Time frame: 8 weeks
Physical Health
weight will be combined to report BMI in kg/m\^2.
Time frame: 8 weeks
sleep quality
Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI) Scoring :0 - No sleep difficulties; 5 or higher - Poor sleep quality
Time frame: 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
Time frame: 8 weeks
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data and supporting documents will be available beginning 6 months after publication of the primary outcomes and will remain available for up to 5 years.
Access criteria: Access may be granted to researchers with methodologically sound proposals for academic or scientific purposes. Requests should be directed to the principal investigator and may require institutional ethical approval and a signed data use agreement.
Data sharing details ↗ · orcid.org
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Jul 2026, 2 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 2 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Fatima Jinnah Women University