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?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Anmol Ayaz, Phd Scholar
- Numéro de téléphone: 923335791127
- E-mail: anmol.ayaz@fjwu.edu.pk
Sauvegarde des contacts de l'étude
- Nom: Sajida Naz Dr
- Numéro de téléphone: +92 323 5493535
- E-mail: dr.sajida@fjwu.edu.pk
Lieux d'étude
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Punjab Province
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Rawalpindi, Punjab Province, Pakistan, 46000
- University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Groupe d'intervention
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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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Improved quality of Life
Délai: 6-8 weeks
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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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Secondary outcome measures include changes in blood glucose level
Délai: 8 weeks
|
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
Délai: 8 weeks
|
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
Délai: 8 weeks
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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
Délai: 8 weeks
|
weight will be combined to report BMI in kg/m^2.
|
8 weeks
|
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sleep quality
Délai: 8 weeks
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Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI) Scoring :0 - No sleep difficulties; 5 or higher - Poor sleep quality |
8 weeks
|
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Psychological Distress
Délai: 8 weeks
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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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- JinnahUW
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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.
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
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