Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holistic mHealth Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Food literacy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anmol Ayaz, Phd Scholar | Contact | 923335791127 | anmol.ayaz@fjwu.edu.pk | |
| Sajida Naz Dr | Contact | +92 323 5493535 | dr.sajida@fjwu.edu.pk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University | Rawalpindi | Punjab Province | 46000 | Pakistan |
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.
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 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.
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D005247 | Feeding Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
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. |
| 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 | 8 weeks |
| Physical Health | weight will be combined to report BMI in kg/m^2. | 8 weeks |
| sleep quality | Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI) Scoring :0 - No sleep difficulties; 5 or higher - Poor sleep quality | 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 | 8 weeks |
| D001522 | Behavior, Animal |
| D001519 | Behavior |