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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-35
SponsorFatima Jinnah Women University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Holistic mHealth Intervention

    Behavioral

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
6-8 weeks

Secondary outcomes

1

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.

Time frame
8 weeks
2

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.

Time frame
8 weeks
3

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

Time frame
8 weeks
4

Physical Health

weight will be combined to report BMI in kg/m\^2.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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