- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02094170
Global Positioning System (GPS) Exposure to Environments & Relations With Biomarkers of Cancer Risk
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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La Jolla, California, Estados Unidos, 92093
- UC San Diego
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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:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Blood Insulin Levels
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
Otros números de identificación del estudio
- 1R01CA179977 (Subvención/contrato del NIH 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. .