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Not yet recruiting NCT07604012

Holistic Lifestyle mHealth Intervention for Risk Reduction of Type 2 Diabetes Mellitus in Young Adults

No phase Interventional Type 2 Diabetes Risk Reduction in Young Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Holistic mHealth Intervention.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Risk Reduction in Young Adults. Basic parameters: 20 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness of Holistic Lifestyle mHealth Intervention for Risk Reduction of Type 2 Diabetes Mellitus in Young Adults: A Randomized Controlled Trial

Overview

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

  • 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.

Primary outcome measures

  • Improved quality of Life [Time frame: 6-8 weeks]
Secondary outcome measures (6)
  • Secondary outcome measures include changes in blood glucose level [Time frame: 8 weeks]
  • Food literacy [Time frame: 8 weeks]
  • Eating Behavior [Time frame: 8 weeks]
  • Physical Health [Time frame: 8 weeks]
  • sleep quality [Time frame: 8 weeks]
  • Psychological Distress [Time frame: 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Pakistan · 1 center
  • University — Rawalpindi

Identifiers

NCT: NCT07604012 · JinnahUW

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗