About this 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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Holistic mHealth Intervention
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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
Physical Health
weight will be combined to report BMI in kg/m\^2.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: