Type 2 Diabetes Risk Reduction in Young Adults
Conditions
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
Brief 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. 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
Interventions
BEHAVIORALHolistic 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.
Sponsors
Fatima Jinnah Women University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved quality of Life | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcome measures include changes in blood glucose level | 8 weeks | 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. |
| Food literacy | 8 weeks | 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. |
| Eating Behavior | 8 weeks | 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 |
| Physical Health | 8 weeks | weight will be combined to report BMI in kg/m\^2. |
| sleep quality | 8 weeks | Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI) Scoring :0 - No sleep difficulties; 5 or higher - Poor sleep quality |
| Psychological Distress | 8 weeks | 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 |
Countries
Pakistan
Contacts
CONTACTAnmol Ayaz, Phd Scholar
CONTACTSajida Naz Dr
Outcome results
None listed