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

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes Risk Reduction in Young Adults
• Intervention / Treatment: Behavioral: Holistic mHealth Intervention

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anmol Ayaz, Phd Scholar; Phone Number: 923335791127; Email: anmol.ayaz@fjwu.edu.pk
• Study Contact Backup: Name: Sajida Naz Dr; Phone Number: +92 323 5493535; Email: dr.sajida@fjwu.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan, 46000
      • University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Group

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.; Other Names: mHealth App; mhealth Intervention; Holistic Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fatima Jinnah Women University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: April 26, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Diabetes Mellitus; Type 2 Diabetes; Randomized Controlled Trial; mHealth; Stress Management; Lifestyle Intervention; Eating Behavior; Lifestyle; Food Literacy; Holistic Lifestyle; Diabetes Risk reduction; Sleep Qaulity
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Behavior; Nutritional and Metabolic Diseases; Behavior, Animal; Diabetes Mellitus, Type 2; Diabetes Mellitus; Motor Activity; Feeding Behavior
• Other Study ID Numbers: JinnahUW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No