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Phone Versus Clinical Approach to Weight Loss

3 de abril de 2014 actualizado por: Joseph Donnelly, University of Kansas

Equivalent Weight Loss for Phone and Clinic Weight Management Programs

Weight loss and maintenance continues to be problematic for individuals who are overweight or obese. State-of-the-art treatment generally involves a behavioral weight loss clinic that emphasizes nutrition, physical activity, and lifestyle changes and is delivered face-to-face between health educators and small groups of participants. This delivery system is time consuming, expensive, and presents numerous barriers to the participant. We have developed a phone based delivery system that eliminates many of these barriers by substituting group conference calls for clinics and by delivering weight loss materials and products directly to the participant.

Hypothesis 1: We expect equivalent weight loss from baseline for phone and clinic groups and have defined equivalence as no greater than 4 kg difference between groups based on our pilot data and potential for clinical significance.

Hypothesis 2: During weight maintenance it is likely that participants will experience some weight re-gain. We expect both phone and clinic groups to re-gain a similar amount of weight and that weight for both groups at 18 months will be significantly less than baseline weights.

Hypothesis 3: We will complete a cost analysis to determine which delivery method is more economical. Specifically, we expect the phone delivery system to be more cost effective than that of the in-person clinics.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Weight loss and maintenance continues to be problematic for individuals who are overweight or obese. State-of-the-art treatment is delivered face-to-face between care providers and small groups of participants and this is time consuming, expensive, and presents numerous barriers to the participant such as travel, conflict with work and home, need for child care, loss of anonymity, and others as well as the care provider such as office space, meeting rooms, inventory, etc. A pilot study of a phone based delivery system versus a traditional clinic has been completed with no difference in weight loss. The phone approach may eliminate many of the barriers of a traditional clinic by substituting conference calls for clinics and by delivering weight loss materials and products directly to the participant. In this fashion, the care provider and participants can reside in any location and receive the same information by conference phone call as that provided by clinic, and receive educational materials, weight management products, etc. by air or ground transportation.

This proposed investigation is a randomized, equivalency trial to test the effectiveness of a phone based weight management program compared to a traditional face-to-face clinic program for weight loss and weight maintenance. It is expected that at 6 months participants in the phone and clinic groups will show equivalent weight loss and that weight loss will be at least 10% lower than baseline. During weight maintenance some weight gain may occur. However, we expect both phone and clinic groups to gain a similar amount of weight and that weight for both groups at 18 months will be significantly less than baseline weights.

A formal cost analysis will be used to determine differences between phone and clinic approaches and extensive process analysis will be used to collect both qualitative and quantitative data to assess how well the programs were implemented as originally designed, challenges and barriers to effective implementation, initial and continual use of program specified activities, quality assurance measures, etc.

Relevance: If successful, the phone approach may eliminate many of the barriers inherent to the traditional face-to-face clinic, may be less expensive, and would potentially open weight management to any individual with access to a phone. We believe the likelihood of translation of this research to the public sector would seem reasonable and promising.

Tipo de estudio

Intervencionista

Inscripción (Actual)

395

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

    • Kansas
      • Lawrence, Kansas, Estados Unidos, 66045
        • Energy Balance Lab, The University of Kansas

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 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 18-65 years,
  • BMI between 25 and 39.9,
  • Clearance from PCP.

Exclusion Criteria:

  • Research project within previous 6 months,
  • Exercise > 500 kcal/week,
  • Pregnancy,
  • Serious medical risk,
  • Eating disorders,
  • Use of special diets.

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Phone based weight management group
Group based weight management program delivered via conference calls
To determine if weight loss is equivalent between individuals that complete weight loss meetings in person versus on the phone.
Otros nombres:
  • Phone based weight management
  • Clinic based weight management
Experimental: Clinic based weight management group
Traditional clinical based group weight management program
To determine if weight loss is equivalent between individuals that complete weight loss meetings in person versus on the phone.
Otros nombres:
  • Phone based weight management
  • Clinic based weight management

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Equivalent weight loss for phone and clinic groups.
Periodo de tiempo: 6 months
6 months

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Equal weight management/regain.
Periodo de tiempo: 12 months
12 months
Cost Analysis
Periodo de tiempo: 18 months
18 months

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Joseph E Donnelly, EdD, University of Kansas

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 julio de 2007

Finalización primaria (Actual)

1 de julio de 2011

Finalización del estudio (Actual)

1 de junio de 2013

Fechas de registro del estudio

Enviado por primera vez

26 de marzo de 2010

Primero enviado que cumplió con los criterios de control de calidad

29 de marzo de 2010

Publicado por primera vez (Estimar)

30 de marzo de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

4 de abril de 2014

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

3 de abril de 2014

Última verificación

1 de abril de 2014

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HSCL16529
  • R01DK076063 (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. .

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