- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01043718
Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study
Hershey Medical Center and the University of Pittsburgh are doing a research study to help meet the needs of the adult population at risk for diabetes and heart disease. This study will provide a web-based program that aims to help participants to develop healthier eating habits, lose weight and become more physically active. The Internet-based materials will teach participants about healthy eating and physical activity and will ask them to incorporate the information they learn into their daily lives.
The purpose of this study is to evaluate the effectiveness of online lifestyle change programs to promote weight loss, healthy eating and physical activity patterns, in the interest of reducing risk for and adverse outcomes of type 2 diabetes (T2D) and cardiovascular disease (CVD).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Milton S. Hershey Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Please note: Only individuals who receive primary care at one of the Internal Medicine clinics at Milton S. Hershey Medical Center in Hershey, PA, are eligible for this study.
Inclusion Criteria:
- Age between 18 and 80 years old
- Obese based on World Health Organization criteria (BMI>30kg/m2)
- Receiving primary care from and referred by a provider at one of the Internal Medicine clinics at Milton S. Hershey Medical Center in Hershey, PA
- Able to understand and sign an informed consent document
- Able to communicate with the investigator and understand the requirements of this study
Exclusion Criteria
- Primary care provider determines that the individual is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)
- Primary care provider determines that the individual has inadequate cognitive function to participate in either active intervention curricula
- Women who are pregnant, who are planning to become pregnant in the next two years, or who become pregnant during the study
- Women who are breastfeeding
- Prisoners
- Children
- Individuals who are planning to have bariatric surgery or who have had bariatric surgery in the past two years
- Individuals with uncontrolled hypertension (systolic blood pressure (SBP) >165, diastolic blood pressure (DBP) >100)
- Individuals with an edematous state that interferes with body weight assessment (e.g., severe congestive heart failure, end- stage renal disease, or ascites),
- Individuals already using weight loss therapy
- Individuals with an inability to learn adequately from English language audio-taped materials
- Individuals with a lack of high-speed Internet access (Internet access will be based on participant perception; for example, participants could use computers belonging to friends, relatives, or libraries if they feel that they can access them regularly)
- Individuals without access to a scale
- Individuals unable to attend an Orientation session at Hershey Medical Center in Hershey, PA
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: More-Intensive
|
The online lifestyle intervention will include elements of a behavioral lifestyle program developed by the Diabetes Prevention Program.
The program will assist individual participants with establishing appropriate weight loss goals, implementing dietary recommendations (including analysis of current diet), and defining exercise programs.
The program curriculum provides standard information about healthy lifestyle, and behavioral techniques for integrating them into daily living.
In each lesson, patients provide feedback about how they interpret the information, and ideas for integrating it into their lives.
|
Comparador activo: Less-Intensive
|
The participants will be provided with the information to access the online Diabetes Prevention Program (DPP) intervention materials.
Following the original DPP trial, all DPP materials were placed online for the public to access.
This group will receive a lifestyle counseling session and tools to facilitate their intervention.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in body weight (kg)
Periodo de tiempo: 6 months, 12 months, 18 months
|
6 months, 12 months, 18 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Percentage of body weight lost
Periodo de tiempo: 6 months, 12 months, 18 months
|
6 months, 12 months, 18 months
|
Change in blood pressure (mm Hg)
Periodo de tiempo: 6 months, 12 months, 18 months
|
6 months, 12 months, 18 months
|
Change in health-related quality of life as determined by the RAND-36 PCS or MCS
Periodo de tiempo: 6 months, 12 months, 18 months
|
6 months, 12 months, 18 months
|
Change in physical activity (steps per day)
Periodo de tiempo: 6 months, 12 months, 18 months
|
6 months, 12 months, 18 months
|
Change in dietary pattern
Periodo de tiempo: 6 months, 12 months, 18 months
|
6 months, 12 months, 18 months
|
Satisfaction with program
Periodo de tiempo: 6 months, 12 months, 18 months
|
6 months, 12 months, 18 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kathleen McTigue, MD MS MPH, University of Pittsburgh
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HMC32877
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. .
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