- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02652845
Wellness Engagement Project, Petersburg (WE)
8 de enero de 2016 actualizado por: Virginia Commonwealth University
This study tests the feasibility of a health and wellness trial designed with community input.
This 12-week program will be tested over a 24-week period using a delayed treatment control group.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This 12-week program was designed based on input from Petersburg, VA community residents, collected through various methods over a two-year period.
The 12 week program is designed to impact three levels: individual, family and community.
At the individual level, participants receive print material lessons related to healthy eating and increasing physical activity, as well as videos that model these lessons; participants will also have access to a peer support coach who will contact them on a biweekly basis and are trained to help them identify and reach their own personal health goals.
At the family level, participants are encouraged to share all of the information they receive as a part of this program with the rest of their family, and are asked to begin walking regularly and to attend fitness and nutrition classes held within their neighborhood (by the WE program) with family members.
On a community level, local church groups and neighborhood organizations will receive assistance in launching walking clubs, and all community residents are invited to attend the physical activity and nutrition classes that the WE project hosts within the community.
Tipo de estudio
Intervencionista
Inscripción (Actual)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
12 años a 65 años (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age between 18-65 years.
- Must have a school going child between 12-17 living in the home.
- BMI between 25 and 50 kg/m2.
Exclusion Criteria:
- report not being able to walk 2 blocks (1/4 mile) without stopping
- currently participating in another weight loss program
- taking a weight loss medication
- have a history of bariatric surgery
- pregnant or plan to become pregnant during the intervention timeframe
- report an unsupervised heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
- report a medical condition that would jeopardize their safety if involved in a weight management program with diet and exercise guidelines (e.g., uncontrolled heart problem)
- fail medical screening by study medical staff)
- report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., planned move from the area, dementia, substance abuse).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Intervention-Wellness Engagement Program
The group assigned to the intervention arm will receive treatment as described below for a twelve week period: Weekly lessons related to healthy eating and physical activity Biweekly check-in calls with a trained peer support coach Access to neighborhood wide physical activity and nutritional education events |
This intervention is an evidence based and community informed program designed to stimulate physical activity and increase healthy food choices among participants.
The intervention includes weekly lessons, personal support in the form of biweekly check in calls with a peer support coach and weekly physical activity and nutrition classes.
|
Sin intervención: Delayed treatment control group
The delayed treatment control group will not receive the intervention for measurement purposes; however the intervention as described will be administered to this group upon conclusion of the 12 week period for the intervention group.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Engagement in WE activities
Periodo de tiempo: 4-weeks
|
Number of community events attended
|
4-weeks
|
Video lessons
Periodo de tiempo: 4 weeks
|
Number of video lessons viewed as reported to Wellness Ambassadors
|
4 weeks
|
Peer Support
Periodo de tiempo: 4 weeks
|
number of check-in phone calls completed with Peer Support Coaches
|
4 weeks
|
Self-monitoring logs
Periodo de tiempo: 4 weeks
|
number of self-monitoring logs completed
|
4 weeks
|
Value of the program
Periodo de tiempo: 4 weeks
|
Perceived value of the program
|
4 weeks
|
Effectiveness of peer support
Periodo de tiempo: 4 weeks
|
Perception of the effectiveness of the peer support received from peer coaches
|
4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Uptake of key behaviors promoted in the WE program
Periodo de tiempo: 4-weeks
|
Engagement in recommended health behaviors
|
4-weeks
|
Weight
Periodo de tiempo: 4-weeks
|
Weight will be measured in kg
|
4-weeks
|
Dietary changes
Periodo de tiempo: 4-weeks
|
Dietary practices will be assessed using the Behavioral Risk Factor Surveillance System (BRFSS)
|
4-weeks
|
Height
Periodo de tiempo: 4 weeks
|
height measured in meters
|
4 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Maghboeba Mosavel, PhD, Virginia Commonwealth University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2015
Finalización primaria (Actual)
1 de agosto de 2015
Finalización del estudio (Actual)
1 de agosto de 2015
Fechas de registro del estudio
Enviado por primera vez
5 de junio de 2015
Primero enviado que cumplió con los criterios de control de calidad
8 de enero de 2016
Publicado por primera vez (Estimar)
12 de enero de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de enero de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
8 de enero de 2016
Última verificación
1 de enero de 2016
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 5R24MD008128 (Subvención/contrato del NIH de EE. UU.)
- 1R24MD008128 (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. .
Ensayos clínicos sobre Wellness Engagement Program
-
University of Illinois at Urbana-ChampaignTerminadoEnvejecimiento | Defecto cognitivo leve | Envejecer bienEstados Unidos
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de ansiedadCanadá
-
Yale UniversityCaravan WellnessAún no reclutandoDepresión | Calidad de vida | Ansiedad | BienestarEstados Unidos
-
The University of Hong KongSydney Children's Hospitals Network; SAHKReclutamientoDesorden del espectro autistaHong Kong
-
Akdeniz UniversityAún no reclutandoAccidente cerebrovascular isquémico | EntrenamientoPavo
-
Ankara City Hospital BilkentTerminado
-
Children's HealthActivo, no reclutandoDesorden del espectro autistaEstados Unidos
-
Endourage, LLCReclutamientoSeguimiento de síntomas en pacientes con COVID prolongado que utilizan gotas sublinguales Formula C™COVID largo | Largo Covid19 | COVID-19 posagudo | Larga distancia COVID | Larga distancia COVID-19 | Síndrome post-agudo de COVID-19Estados Unidos
-
IRCCS San RaffaeleTerminadoCancer de pancreas | Diagnóstico | InteracciónItalia
-
Endourage, LLCTerminado