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The Deep South IVR-based Active Lifestyle Study (DIAL)

30 de diciembre de 2019 actualizado por: Dorothy Pekmezi, PhD, University of Alabama at Birmingham

The Deep South IVR-based Active Lifestyle (DIAL) Study

This pilot study represents an initial foray into delivering an Individual Voice Response-based (IVR) physical activity intervention for cancer risk among sedentary adults in the Deep South.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

60 participants will receive the DIAL intervention or Wait List Control. While main outcomes are focused on feasibility and acceptability, physical activity, fitness, and body weight and composition data will be collected and measured at baselines and 12-weeks.

DIAL Intervention: The physical activity intervention is based on Social Cognitive Theory and emphasizes behavioral strategies for increasing activity levels (i.e., goal setting, self-monitoring, problem solving barriers, increasing social support, rewarding oneself for meeting physical activity goals) and includes daily activity reporting via an Individual Voice Response (IVR) system that allows computer-assisted interaction with participants by telephone. Computer expert system feedback on physical activity progress will be based on participants' reported daily step counts and >moderate intensity PA . In addition to IVR system feedback, participants will receive monthly graphic-based feedback letters delivered by mail. Messages will encourage incremental increases until national PA guidelines are reached and provide specific information on cancer risk reduction ("In the past 7 days, you called the DIAL study line all 7 days and reported engaging in 80 minutes of moderate intensity PA. The national guidelines call for >150 min/week of moderate intensity PA so you are well on your way. Keep up the good work. Make small increases in PA each week until you reach that goal. Remember: 30-60 min/day of moderate-vigorous intensity PA may significantly lower your risk of breast and colon cancer").

To improve self-efficacy, social support, outcome expectations, and perceived enjoyment, we will assess these variables at baseline, 30, 60, and 90 days. Responses will be used to select appropriate tailored feedback modules (for low self-efficacy score, "You do not seem confident about your ability to exercise. Often trying to fit in some PA on top of the demands of work and family can be a challenge. Try making time for a 10 minute walk 1-2 days this week. It will help build confidence about your ability to fit PA into your lifestyle.") Finally, participants will receive access to problem solving modules, addressing PA barriers identified by the community during formative research (lack of time, negative outcome expectations, enjoyment, social support, see table below). Module options will be rotated and constantly updated to keep participants engaged.

Wait List Control Condition: Will receive the intervention after 12 weeks following baseline assessments.

Tipo de estudio

Intervencionista

Inscripción (Actual)

62

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

    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • University of Alabama at Birmingham

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

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 21 years or older
  • Underactive (<60 min/week moderate PA)
  • Able to speak/read English
  • Willing to be assigned to either condition
  • Access to a telephone
  • Not planning to move from the area in the next 4 months
  • Healthy (BMI 18.5-45; No history of heart disease, myocardial infarction, angina, stroke, or orthopedic conditions which limit mobility, or any serious medical condition that would make physical activity unsafe; no psychiatric hospitalization in past 3 years).

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: DIAL Intervention
The physical activity intervention emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals), and includes daily IVR-system call feedback and monthly graphic-based feedback delivered in the mail. In addition, social support, outcome expectations and perceived physical activity enjoyment variables will be assessed at baseline, 30, 60, and 90 days. Responses will be used to select appropriate tailored feedback modules.
The physical activity intervention is based on Social Cognitive Theory and includes feedback on physical activity progress via IVR system and monthly graphic-based feedback letters delivered in the mail. Messages will encourage incremental increases until national PA guidelines are reached and provide specific information on cancer risk reduction.
Comparador activo: Wait List Control
Access to the intervention 12 weeks following baseline assessment.
Access to DIAL intervention 12 weeks following baseline assessment.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Consumer Satisfaction Survey
Periodo de tiempo: 3 months
Satisfaction with IVR-based system intervention
3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
7 Day Physical Activity Recall
Periodo de tiempo: Baseline and 3 months
minutes/week of moderate intensity or greater physical activity
Baseline and 3 months
6 Minute Walk Test
Periodo de tiempo: Baseline and 3 months
meters walked in 6 minutes
Baseline and 3 months
body mass index
Periodo de tiempo: Baseline and 3 months
kg/m^2
Baseline and 3 months
waist circumference
Periodo de tiempo: Baseline and 3 months
cm
Baseline and 3 months
body impedance analyses
Periodo de tiempo: Baseline and 3 months
% body fat
Baseline and 3 months
Social Support for exercise scale
Periodo de tiempo: Baseline, 1 month, 2 months, and 3 months
range=0-65 for both friends and family subscales, with higher scores indicating more social support
Baseline, 1 month, 2 months, and 3 months
Outcome expectations scale
Periodo de tiempo: Baseline, 1 month, 2 months, and 3 months
range= 1-5, with higher scores representing more outcome expectations
Baseline, 1 month, 2 months, and 3 months
Physical Activity Enjoyment scale
Periodo de tiempo: Baseline, 1 month, 2 months, and 3 months
range=18-126, with higher scores indicating more enjoyment
Baseline, 1 month, 2 months, and 3 months
Self -Efficacy for Exercise Measure
Periodo de tiempo: Baseline, 1 month, 2 months, and 3 months
range= 1-5, with higher scores representing more self-efficacy
Baseline, 1 month, 2 months, and 3 months
Accelerometers
Periodo de tiempo: Baseline and 3 months
minutes/week of moderate intensity or greater physical activity
Baseline and 3 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Dori Pekmezi, PhD, University of Alabama at Birmingham

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 2015

Finalización primaria (Actual)

1 de junio de 2017

Finalización del estudio (Actual)

1 de diciembre de 2019

Fechas de registro del estudio

Enviado por primera vez

8 de diciembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

8 de diciembre de 2015

Publicado por primera vez (Estimar)

10 de diciembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de enero de 2020

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

30 de diciembre de 2019

Última verificación

1 de diciembre de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • X131203002
  • 1R03CA177538 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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 DIAL

3
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