Holistic Lifestyle mHealth Intervention for Risk Reduction of Type 2 Diabetes Mellitus in Young Adults
Effectiveness of Holistic Lifestyle mHealth Intervention for Risk Reduction of Type 2 Diabetes Mellitus in Young Adults: A Randomized Controlled Trial
1 other identifier
interventional
30
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
May 22, 2026
May 1, 2026
3 months
April 26, 2026
May 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Secondary outcome measures include changes in blood glucose level
8 weeks
Food literacy
8 weeks
Eating Behavior
8 weeks
Physical Health
8 weeks
sleep quality
8 weeks
- +1 more secondary outcomes
Study Arms (1)
Intervention Group
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University
Rawalpindi, Punjab Province, 46000, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 26, 2026
First Posted
May 22, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.