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

Официальное название

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

Обзор

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?

Подробное описание

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

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Improved quality of Life [Срок оценки: 6-8 weeks]

Вторичные конечные точки (6)

• Secondary outcome measures include changes in blood glucose level [Срок оценки: 8 weeks]
• Food literacy [Срок оценки: 8 weeks]
• Eating Behavior [Срок оценки: 8 weeks]
• Physical Health [Срок оценки: 8 weeks]
• sleep quality [Срок оценки: 8 weeks]
• Psychological Distress [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Пакистан · 1 центр

• University — Rawalpindi

Идентификаторы

NCT: NCT07604012 · JinnahUW

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗