- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05154227
Health@NUS - Studying Health Behaviours and Well-being During the Student-to-Work Life Transition Using mHealth
The study aims to investigate body-weight and behavioural trajectories, as well as their underlying individual, social, and environmental determinants from University to early working life. The study employs mHealth approaches in the form of a smartphone app and smart wearables to collect health behaviour and related information to answer the following research questions:
- To what extend do health behaviours (activity, diet, and sleep), body weight, and mental well-being change during the transition from university to early working life?
- What is the relationship between health behaviours and mental well-being, and how does it differ at different stages of the transition from University to early working life?
- What are the determinants of physical activity, healthy eating and sleep in university students and young working adults?
- Do these determinants differ at different stages of the student to work life transition?
- If so, how do these differences in these determinants relate to changes in health behaviours, weight status, and mental well-being?
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This is a prospective cohort study. The study period for each participant is 2 years. Participants are required to download the study's smartphone app and wear the assigned smartwatch to collect various information (including step counts and sleep time). Physical measurements are taken in person at baseline, 12 months and 24 months visits. These measurements include height, weight, waist circumference, resting heart rate and blood pressure.
Questionnaires administered at baseline, 12 months and 24 months include:
- Demographics (age, gender, religion, socio-economic status, education level)
- Personality
- Dietary intake and habits
- Physical activity, sedentary behavior and screen time
- Active and passive transport use
- Smoking habit
- Sleep quality
- Mental health and wellness
- Medical history
- Women's health-related
Participants will also receive occasional surveys sent to their smartphone through the study app. These surveys will include questions about sleep, diet, technology use, binge drinking, smoking, physical activities and/or emotions.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chua Xin Hui
- Número de teléfono: +65-6601-1940
- Correo electrónico: xinhui.chua@nus.edu.sg
Copia de seguridad de contactos de estudio
- Nombre: Tay Zoey
- Correo electrónico: ephtz@nus.edu.sg
Ubicaciones de estudio
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Singapore, Singapur, 117597
- Reclutamiento
- Saw Swee Hock School of Public Health, National University of Singapore
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Contacto:
- Yeo Shumian
- Número de teléfono: +65-66013442
- Correo electrónico: yshumian@nus.edu.sg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Full time National University of Singapore students (undergraduate and postgraduate)
- Singapore Citizen or Permanent Resident;
- Has a Singapore registered mobile number• Owns a mobile phone with operating system that is compatible with the study app (iOS 10 or Android 7 and above);
- Able to make the upfront deposit of $20 and able to set up the Direct Debit Authorization (DDA) for possible deductions by HPB;
- Able to understand the study procedure during the informed consent taking process.
Exclusion Criteria:
- Students who will be overseas for more than 6 weeks per trip during the study period (e.g. involved in overseas exchange/internship programmes or stationed overseas) or travelling frequently;
- Students who are not able to set up the DDA via online method will be excluded;
- Students who has worked in a full-time position for more than a year previously;
- Pregnant women will be excluded only at the point of recruitment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Changes in health behaviours - physical activity
Periodo de tiempo: Baseline, 12 and 24 months follow up
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Baseline, 12 and 24 months follow up
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Changes in health behaviours - dietary pattern
Periodo de tiempo: Baseline, 12 and 24 months follow up
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Baseline, 12 and 24 months follow up
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Changes in health behaviours - sleep pattern
Periodo de tiempo: Baseline, 12 and 24 months follow up
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Baseline, 12 and 24 months follow up
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Changes in health behaviours - mental well-being
Periodo de tiempo: Baseline, 12 and 24 months follow up
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Baseline, 12 and 24 months follow up
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Blood pressure (mmHG)
Periodo de tiempo: Baseline, 12 and 24 months follow-up
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Baseline, 12 and 24 months follow-up
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Resting heart rate (bpm)
Periodo de tiempo: Baseline, 12 and 24 months follow-up
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Baseline, 12 and 24 months follow-up
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Body Mass Index (kg/m^2)
Periodo de tiempo: Baseline, 12 and 24 months follow-up
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Baseline, 12 and 24 months follow-up
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Waist circumference (cm)
Periodo de tiempo: Baseline, 12 and 24 months follow-up
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Baseline, 12 and 24 months follow-up
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Falk Müller-Riemenschneider, National University, Singapore
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Health@NUS
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .