- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02094170
Global Positioning System (GPS) Exposure to Environments & Relations With Biomarkers of Cancer Risk
Visão geral do estudo
Status
Condições
Descrição detalhada
The purpose of this study is to advance methods of cancer risk exposure assessment by measuring both neighborhood access and total environment exposure to healthy environments by dynamically integrating Global Positioning System (GPS) data with Geographical Information System (GIS) data. We hypothesize that dynamic GPS based measures of environmental exposure will be more strongly related to behavior and insulin and inflammation biomarkers than static address based GIS measures of access.
Primary Aim:
To compare Dynamic vs Static GIS measures of physical activity (PA) supportivity and their associations with PA behaviors, body mass index (BMI), and biological markers.
Secondary Aim:
To compare Dynamic vs Static GIS measures of access to healthy food and their associations with dietary intake, BMI, and biological markers.
Exploratory aim:
Social environment (e.g. eating with others) has been identified as an important determinant of health, but assessment of this has been limited to self-report through surveys or text prompts. Images from a person worn camera (the SenseCam) provide an objective and continuous assessment of social environment e.g. number of social interactions per day, eating alone or with others. In a subsample of participants (N=30), we propose to explore whether portable SenseCam measures of social interactions & social behaviors from person view images are more strongly related to breast and colon cancer risk factors than self-reported social environment measures. Behaviors and built environments (especially food locations) can also be coded to validate the accuracy of the GIS measures and the machine learned behavior categories employed in the full sample.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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California
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La Jolla, California, Estados Unidos, 92093
- UC San Diego
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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:
- 35 - 80 years
- live in the same residence selected for the study for at least one year
- are able to walk without human assistance
- are able to read and write fluently in English or Spanish
- have a stable phone
- leave their home at least 3 or more times per week
- have a stable weight over the past 3 months (+/- 5 lbs)
- spend most of their time within San Diego County
- will be in San Diego County for the study period (i.e. not travel or border crossing)
- are able to give informed consent and comply with the protocol
- are willing to complete all assessments and wear all devices for 14 days.
Exclusion Criteria:
- are younger than 435 or older than 80 years of age
- are pregnant or nursing
- have a mental state that would preclude complete understanding of the protocol or compliance
- have a chronic illness that may be associated with weight change
- are participating in another clinical trial
- have type 1 diabetes
- have an autoimmune disorder such as lupus, rheumatoid arthritis, or multiple sclerosis
- have an intestinal disease such as celiac disease, Crohn's disease, or inflammatory bowel disease (IBD) or sensitivities or allergies to gluten
- have psoriasis
- have a history of or a current eating disorder
- have had previous weight loss surgery
- plan to travel into Mexico during the two-week study period or have a history of travel to Mexico
- are taking second generation or "atypical" antipsychotics
- live with someone else who is participating in this study
- are currently taking weight loss supplements and unwilling to stop for a predetermined "wash-out" period
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Blood Insulin Levels
Prazo: 14 Days
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14 Days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jacqueline Kerr, PhD, UC San Diego
Publicações e links úteis
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 (Real)
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
- 1R01CA179977 (Concessão/Contrato do NIH 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 .