- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02031185
A Wearable mHealth Device to Promote Teenagers' Physical Activity
A Wearable mHealth Device to Promote Teenagers' Physical Activity: A Pilot RCT
Due to disparities in childhood obesity, interventions for physical activity promotion and obesity prevention for low socioeconomic and racial/ethnic minority children and adolescents are vital to address disparities across the lifespan. Mobile health applications (mHealth apps) are a rapidly growing and promising approach for interactive and individualized interventions for disease prevention. Smart phones are a promising platform to reach racial/ethnic minority and lower income groups due to high rates of adoption of smart phone usage among these groups When paired with wearable sensing devices, mHealth apps for smart phones can collect data and provide feedback to users in real time. In a study among university students regarding mHealth apps, participants expressed interest in the "ability to record and track behaviors and goals and the ability to acquire advice and information 'on the go'". For physical activity in particular, wearable physical activity monitors designed for consumers that objectively measure and display data related to an individual's physical activity on smart phones through mHealth apps have become widely available and affordable. These wearable devices wirelessly upload data and provide users with physical activity data visualization and goal setting features that can be customized for each user via internet-based applications for smart phones, tablets, and/or computers. While several internet-based behavioral programs to promote pediatric physical activity have been reported in a recent review, none examined wearable sensing devices coupled with mHealth apps. Similarly, a 2013 review on mHealth technologies for physical activity assessment and promotion reported no studies that used wearable sensing devices for intervention delivery and called for research to evaluate feasibility.
The Primary Goal is to conduct a pilot randomized controlled trial (RCT) of the FitBit Flex, a popular wearable physical activity sensing device that allows data visualization and goal setting on smart phones. The target population will be adolescents ages 14-18 years old in the Seattle-metro area (n=40) with approximately 50% from low income households or belonging to a racial/ethnic minority. We will target this older age group since they have the lowest levels of physical activity among the pediatric population. This pilot study will provide feasibility and preliminary data for a future R01-funded RCT of the Flex mHealth device and app.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Washington
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Seattle, Washington, Estados Unidos, 98145-5005
- Seattle Children's Research Institute
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 14-18 years old
- lives in the Seattle-metro area
- able to complete forms in English
- no restrictions by a health care provider on physical activity or walking
- own a smart phone or similar FitBit compatible mobile device (e.g. iPod Touch)
- agree to install and share data from the FitBit Flex smart phone app with the investigators
- attends study high school or health clinic or receives and clicks on a Facebook advertisement for the study
Exclusion Criteria:
- has been restricted by a health care provider for physical activity or walking
- does not live in the Seattle-metro area
- does not attend a study school or clinic, or did not receive a Facebook advertisement for the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Controle de lista de espera
Sem intervenção
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Experimental: FitBit only
Participants will use the FitBit device
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Participants will use the FitBit device
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Experimental: FitBit and Text Messages
Participants will use the FitBit device and receive daily affective text messages
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Participants will use the FitBit device and receive daily affective text messages
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Post-intervention daily steps
Prazo: Measured during weeks 3-4 of the intervention
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Measured during weeks 3-4 of the intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pre-intervention daily steps
Prazo: Baseline
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Baseline
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Pre-intervention moderate-to-vigorous physical activity (MVPA)
Prazo: Baseline
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Accelerometry
|
Baseline
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Post-intervention moderate-to-vigorous physical activity
Prazo: During weeks 3-4 of the intervention
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accelerometry
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During weeks 3-4 of the intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jason A Mendoza, MD, MPH, University of Washington
- Investigador principal: Megan Moreno, MD, MPH, University of Washington
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- SCRI-24100018
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