- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01339390
MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in the Veterans Health Administration (VHA)
MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in VHA
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: Obesity increases the prevalence and severity of cardiovascular risk factors such as hypertension, diabetes, and metabolic syndrome. It is also a leading contributor to cancer and osteoarthritis. Obesity and overweight are highly prevalent among VHA patients: As with the general population, over two-thirds of VHA users are either overweight or obese. There is good evidence that intensive weight reduction programs can have a modest-but clinically significant-impact on weight. VHA has developed a comprehensive weight management program known as MOVE! to address obesity among its patients. MOVE! evaluations to date have demonstrated success in helping Veterans lose weight, but participation is low. In the investigators' preliminary work, the investigators found that the timing (daytime) and location (ZVAMC) of MOVE! activities were viewed by eligible patients as barriers to participation. In addition, previous research has often demonstrated significant rebound in weight at the end of formal program activities, which may be mitigated if there is a convenient place for ongoing weight monitoring and healthy activities with peers.
Objectives: The overall goal of the project is to increase participation in the ZVAMC MOVE! program by implementing an innovative community-based program known as MOVE OUT. MOVE OUT will incorporate the key elements of the proven MOVE! program (education, peer support, and planned physical activity), but in settings closer to the homes of eligible Zablocki patients. The investigators have the following objectives:
- To reduce the mean weight of high-risk overweight or obese Veterans who receive primary care at ZVAMC.
- To improve the physical activity and diet of high-risk overweight or obese Veterans who receive primary care at ZVAMC.
- To demonstrate that an innovative community-based program can increase the proportion of ZVAMC users who participate actively in a moderately intensive weight management program as recommended by the National Institutes of Health Consensus Conference on Obesity.
Methods: The investigators will use a cluster randomized trial design. The investigators will allocate groups of eligible Veterans from ZVAMC to either a MOVE OUT invitation or a standard MOVE! invitation. The investigators will use clinically gathered weight data to determine overall rates of weight loss in the randomly assigned Veterans. In addition, the investigators will recruit a sample of Veterans from each randomized group to participate in a study of the effectiveness of the weight management program to which they are assigned. The investigators will use established methods to assess changes in diet, exercise and attitude, as well as physiologic outcomes including weight, blood pressure, Hemoglobin A1c, and lipid values. The investigators will use qualitative methods to learn what aspects of the two programs are most effective.
Impact: The investigators will demonstrate that VHA can deliver effective weight management services in a community-based fashion. If this study finds that such a delivery approach leads to an increased number of at-risk Veterans participating in weight control programs, it will guide program design throughout VHA. Although weight management is particularly well suited to a disseminated delivery model, lessons learned from this research are likely to help VHA improve its ability to help patients self-manage a variety of chronic diseases.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53295-1000
- Clement J. Zablocki VA Medical Center, Milwaukee, WI
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Visit to ZVAMC primary provider within 3 months
- BMI >= 30 OR BMI >= 25 and Hypertension or Diabetes Mellitus
- No scheduled appointment for a MOVE program clinic
- Age <= 75 years
- Live in targeted geographic region
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Arm 1: MOVE OUT
The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE! program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.
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The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.
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Comparador activo: Arm 2: MOVE!
As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a "clinical reminder."
This reminder prompts the primary care provider (PCP) to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial.
The MOVE! program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.
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As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a "clinical reminder."
This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial.
The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Weight (From Baseline)
Periodo de tiempo: Measured at 12 and 24 months
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Weight as recorded in the medical record during a 6-month period around the follow-up point.
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Measured at 12 and 24 months
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Colaboradores e Investigadores
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IIR 10-327
- 1I01HX000562-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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 MOVE OUT
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Johns Hopkins Bloomberg School of Public HealthMakerere University; Pontificia Universidad Javeriana; The Bloomberg Family Foundation...TerminadoEnfermedades no transmisibles | Encuestas y CuestionariosColombia, Uganda
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Mayo ClinicRetirado
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Brandon HathornBaylor Heart and Vascular Institute Cardiovascular Research Review CommitteeTerminadoEnfermedad de la arteria coronaria | Enfermedad de las Válvulas, Corazón
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NGMedical GmbHReclutamientoRadiculopatía | Estenosis Espinales | Discopatía | Disco cervical herniadoAustria, Alemania
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University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI)TerminadoSobrepeso y Obesidad | La inactividad físicaEstados Unidos