- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02627235
The Deep South IVR-based Active Lifestyle Study (DIAL)
The Deep South IVR-based Active Lifestyle (DIAL) Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham
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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:
- 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
¿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.
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Access to DIAL intervention 12 weeks following baseline assessment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Consumer Satisfaction Survey
Periodo de tiempo: 3 months
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Satisfaction with IVR-based system intervention
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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
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Baseline and 3 months
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6 Minute Walk Test
Periodo de tiempo: Baseline and 3 months
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meters walked in 6 minutes
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Baseline and 3 months
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body mass index
Periodo de tiempo: Baseline and 3 months
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kg/m^2
|
Baseline and 3 months
|
waist circumference
Periodo de tiempo: Baseline and 3 months
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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
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range=0-65 for both friends and family subscales, with higher scores indicating more social support
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Baseline, 1 month, 2 months, and 3 months
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Outcome expectations scale
Periodo de tiempo: Baseline, 1 month, 2 months, and 3 months
|
range= 1-5, with higher scores representing more outcome expectations
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Baseline, 1 month, 2 months, and 3 months
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Physical Activity Enjoyment scale
Periodo de tiempo: Baseline, 1 month, 2 months, and 3 months
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range=18-126, with higher scores indicating more enjoyment
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Baseline, 1 month, 2 months, and 3 months
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Self -Efficacy for Exercise Measure
Periodo de tiempo: Baseline, 1 month, 2 months, and 3 months
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range= 1-5, with higher scores representing more self-efficacy
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Baseline, 1 month, 2 months, and 3 months
|
Accelerometers
Periodo de tiempo: Baseline and 3 months
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minutes/week of moderate intensity or greater physical activity
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Baseline and 3 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dori Pekmezi, PhD, University of Alabama at Birmingham
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
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)?
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
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University of RochesterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...Activo, no reclutandoEnfermedades Renales Crónicas | Enfermedad renal en etapa terminalEstados Unidos
-
Universitair Ziekenhuis BrusselAún no reclutando
-
University of ValenciaUniversitat Politècnica de València; Iniciativa Social Integral; Las NavesAún no reclutandoDepresión | Calidad de vida | Ansiedad | Soledad
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Vance Thompson VisionDesconocidoHipertensión Ocular | Glaucoma | Sospechoso de glaucoma | Ángulo abierto, bajo riesgoEstados Unidos
-
Zimmer BiometInscripción por invitaciónLesiones de hombro | Dolor de hombro | Fracturas de hombro | Artritis del hombro | Enfermedad del hombroEstados Unidos
-
University of North Carolina, Chapel HillBoehringer IngelheimTerminado
-
EquinoxTerminadoGlaucoma, de ángulo abiertoEstados Unidos
-
Shanghai Zhongshan HospitalDesconocidoAfección pulmonar obstructiva crónicaPorcelana
-
Zimmer BiometInscripción por invitaciónLesiones de hombro | Dolor de hombro | Fracturas de hombro | Artritis del hombro | Enfermedad del hombroEstados Unidos
-
Pennington Biomedical Research CenterReclutamientoPérdida de peso | Envejecimiento | Adherencia al tratamientoEstados Unidos