Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Efficacy of a Web-based Tailored Weight Management Program

25 de julio de 2011 actualizado por: Robert Wood Johnson Foundation

Efficacy of a Web-based Tailored Weight Management Program With and Without Tailored Nutrition and Goal Setting Support

The primary objective of this study is to assess the benefit of using online, tailored behavioral weight management materials (Balance), in combination with nutritional materials (Balance and Nourish), in conjunction with a goal setting tool (Balance and Achieve), or a combination of all three (Balance, Nourish and Achieve). This objective will be evaluated by measuring weight loss rates as reported by study participants at 3, 12, and 18 months post-enrollment. The hypothesis is that adding additional materials will increase the effect of the intervention over just using Balance alone.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

This will be a randomized control, web-based trial for weight management with four treatment arms. Participants will be assigned to receive tailored materials from either: 1) the Balance program, 2) the Balance and Nourish programs, 3) the Balance and Achieve programs, or 4) the Balance, Nourish and Achieve programs. Participants will be recruited directly through their health care organization. In order to participate, participants must visit the website to confirm their eligibility, e.g. valid e-mail address. Those who wish to participate will provide consent on the Web, and then will be presented with an online questionnaire. These questions will provide baseline data for each participant and will be the basis for the tailoring of the Balance materials each participant will receive. Within 24 hours of submitting the completed questionnaire, participants will be informed by e-mail that their tailored Balance plan is available on the website. They will receive follow-up materials by e-mail during the six-week period after they enroll. Participants who have been assigned to additional programs will be sent e-mails with links to the relevant programs. At 3, 12 and 18 months, all participants will be assessed via an online survey. The assessment will include weight management parameters, psychosocial outcomes, and program utilization. This data will be self-reported.

STUDY POPULATION The study sample will be drawn from members of three integrated delivery systems: Kaiser Permanente Colorado (KPCO), Kaiser Permanente Ohio (KPOH), and Group Health Cooperative (GHC) of Puget Sound. In order to participate, participants must access and enroll in the study on the Web. A total of 1,848 participants will be enrolled within a six-month period, with approximately 450 participants in each treatment arm. By 18-month follow-up, we assume successful data collection from at least 65 percent of the enrollees, or 1200 participants, 300 in each treatment group. The study is open to those who meet the inclusion and exclusion criteria.

Tipo de estudio

Intervencionista

Inscripción

1848

Fase

  • Fase 2
  • Fase 3

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

    • California
      • Walnut Creek, California, Estados Unidos, 94596
        • Kaiser Permanente Care Management Institute

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

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. 18-75 years of age
  2. Current KP or GHC member
  3. BMI greater than or equal to 30 or BMI greater than or equal to 25 and have one of the following chronic illnesses: diabetes, coronary artery disease, depression, or asthma, or arthritis.
  4. Agree to be contacted via computerized questionnaire at 3, 12 and 18 months post-enrollment
  5. Regular access to the Internet and a functioning e-mail address

Exclusion Criteria:

  1. Current use of pharmacologic, behavioral or surgical treatment for weight loss
  2. Currently pregnant or planning pregnancy
  3. Inability to read English.
  4. Presence of Congestive Heart Failure
  5. KP Ohio region members who participated in the original THeME study

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

  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Único

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
The primary objective of this study is to assess weight reduction at 3, 12, and 18 months post intervention.

Medidas de resultado secundarias

Medida de resultado
• To assess psychosocial outcomes including motivation and self-efficacy.
• To assess the degree to which participants perceive their support materials have been tailored for them.
• To assess lifestyle changes including physical activity and nutrition
• To examine relative effectiveness of web-based programs given age, gender, preferred language, ethnicity, and utilization patterns.
• To examine percent of weight loss goal attainment.
• To examine participation rates by the BMI strata stated above.
• To assess the perceived helpfulness of the behavioral support materials with the participants' weight loss attempts.
• To assess the overall satisfaction with the programs.
• To assess participant satisfaction with Kaiser Permanente or GHC.
• To assess changes in self-reported health status.
• To assess changes in self-reported medical outpatient utilization.
• To assess self-reported work productivity (days missed from work or school).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Kevin J Wildenhaus, Ph.D., HealthMedia, Inc.
  • Investigador principal: Russ Glasgow, Ph.D., Kaiser Permanente

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 septiembre de 2003

Finalización del estudio (Actual)

1 de julio de 2006

Fechas de registro del estudio

Enviado por primera vez

24 de enero de 2006

Primero enviado que cumplió con los criterios de control de calidad

27 de enero de 2006

Publicado por primera vez (Estimar)

31 de enero de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

27 de julio de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

25 de julio de 2011

Última verificación

1 de julio de 2011

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 49147

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. .

3
Suscribir