- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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?
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Contactos e Locais
Contato de estudo
- Nome: Chua Xin Hui
- Número de telefone: +65-6601-1940
- E-mail: xinhui.chua@nus.edu.sg
Estude backup de contato
- Nome: Tay Zoey
- E-mail: ephtz@nus.edu.sg
Locais de estudo
-
-
-
Singapore, Cingapura, 117597
- Recrutamento
- Saw Swee Hock School of Public Health, National University of Singapore
-
Contato:
- Yeo Shumian
- Número de telefone: +65-66013442
- E-mail: yshumian@nus.edu.sg
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Changes in health behaviours - physical activity
Prazo: Baseline, 12 and 24 months follow up
|
Baseline, 12 and 24 months follow up
|
Changes in health behaviours - dietary pattern
Prazo: Baseline, 12 and 24 months follow up
|
Baseline, 12 and 24 months follow up
|
Changes in health behaviours - sleep pattern
Prazo: Baseline, 12 and 24 months follow up
|
Baseline, 12 and 24 months follow up
|
Changes in health behaviours - mental well-being
Prazo: Baseline, 12 and 24 months follow up
|
Baseline, 12 and 24 months follow up
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Blood pressure (mmHG)
Prazo: Baseline, 12 and 24 months follow-up
|
Baseline, 12 and 24 months follow-up
|
Resting heart rate (bpm)
Prazo: Baseline, 12 and 24 months follow-up
|
Baseline, 12 and 24 months follow-up
|
Body Mass Index (kg/m^2)
Prazo: Baseline, 12 and 24 months follow-up
|
Baseline, 12 and 24 months follow-up
|
Waist circumference (cm)
Prazo: Baseline, 12 and 24 months follow-up
|
Baseline, 12 and 24 months follow-up
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Falk Müller-Riemenschneider, National University, Singapore
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Health@NUS
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .