- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03047590
Comparison of Affect-based, Self-selected, and Traditional Exercise Prescriptions
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The purpose of this study is to determine if an "affect-based" or "choice-based" exercise prescription is more effective for behavior change than a traditional, "moderate-intensity" exercise prescription. Prior research suggests that "choice-based" or "self-selected" exercise intensity is more pleasant and adhered to than "moderate-intensity exercise" (Williams et al., 2014). Similarly, affect-based exercise prescriptions (i.e., an exercise prescription where intensity is regulated based on the pleasure-displeasure one feels while exercising) appear to have merit (Baldwin, Kangas, Denman, Smits, Yamada, & Otto, 2016).
However, choice-based and affect-based exercise prescriptions have not been compared to each other. Further, it is unknown if it is the intensity regulation that matters (e.g., "choose an intensity that feels good" or the focus on affect (e.g., "focus on feeling good). Third, prior research has not objectively measured physical activity behavior.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27701
- Duke University IBRC Lab
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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:
- Must be fluent in English
- Must be able to walk
- Exercise less than 90 minutes per week at a moderate-intensity
- Must be able to attend laboratory visits
- Must have mobile internet accent and a personal smartphone (iPhone iOS 9+ or Android OS 4.3+)
- Can safely exercise at an intensity that is at least "moderate"
Exclusion Criteria:
- People who are recommended to have medical clearance prior to exercising, according to the American College of Sports Medicine's preparticipation screening criteria, will be excluded
Plan de estudios
¿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 |
|---|---|
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Experimental: Choice-No Affect
These participants self-select (i.e., choose) their exercise intensity with the goal of walking 30-60 minutes on most days of the week.
For safety reasons, they are instructed not to exceed 59% of their heart rate reserve.
This is choice-based exercise intensity with no focus on positive affect.
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Participants are instructed to choose whichever intensity they want, rather than regulate their intensity based on heart rate.
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Experimental: Choice-Affect
These participants self-select their exercise intensity with the goal of walking 30-60 minutes on most days of the week.
They're instructed to choose the intensity that makes them feel the best.
For safety reasons, they are instructed not to exceed 59% of their heart rate reserve.
This is choice-based exercise intensity with a focus on positive affect.
|
Participants are instructed to choose whichever intensity they want, rather than regulate their intensity based on heart rate.
Participants are instructed to focus on feeling good while exercising.
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|
Experimental: No Choice-Affect
These participants regulate their exercise intensity using their heart rate, with the goal of walking 30-60 minutes on most days of the week.
The intensity is "moderate" according to the American College of Sports Medicine (40-59% of their heart rate reserve).
Meanwhile, these participants are instructed to focus on the "good feelings" that come with exercise.
this is heart rate-based exercise intensity with a focus on positive affect.
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Participants are instructed to focus on feeling good while exercising.
Participants are instructed to regulate their exercise intensity based on their heart rate.
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Comparador activo: No Choice-No Affect
These participants regulate their exercise intensity using their heart rate, with the goal of walking 30-60 minutes on most days of the week.
The intensity is "moderate" according to the American College of Sports Medicine (40-59% of their heart rate reserve).
This is heart rate-based exercise intensity with no focus on positive affect.
|
Participants are instructed to regulate their exercise intensity based on their heart rate.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in objectively measured exercise behavior
Periodo de tiempo: This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)
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Minutes per week of objectively measured exercise behavior.
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This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in self-reported exercise behavior
Periodo de tiempo: This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)
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Minutes per week of self-reported exercise behavior that is reported using exercise log.
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This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)
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Change in affective attitudes
Periodo de tiempo: Measured during baseline assessment period and at the end of the intervention
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Affective attitudes toward exercise
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Measured during baseline assessment period and at the end of the intervention
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Self-reported intrinsic motivation (questionnaires)
Periodo de tiempo: Two weeks into study intervention
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Intrinsic motivation for exercise program
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Two weeks into study intervention
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Enjoyment
Periodo de tiempo: Measured at the end of the intervention period (4 weeks)
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Enjoyment of exercise program.
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Measured at the end of the intervention period (4 weeks)
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Change in weight
Periodo de tiempo: Measured at the beginning and end of the study (6 weeks).
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Body weight
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Measured at the beginning and end of the study (6 weeks).
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Change in resting heart rate
Periodo de tiempo: Measured at the beginning and end of the study (6 weeks).
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Resting heart rate
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Measured at the beginning and end of the study (6 weeks).
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Baldwin AS, Kangas JL, Denman DC, Smits JA, Yamada T, Otto MW. Cardiorespiratory fitness moderates the effect of an affect-guided physical activity prescription: a pilot randomized controlled trial. Cogn Behav Ther. 2016 Nov;45(6):445-57. doi: 10.1080/16506073.2016.1194454. Epub 2016 Jun 16.
- Williams DM, Dunsiger S, Miranda R Jr, Gwaltney CJ, Emerson JA, Monti PM, Parisi AF. Recommending self-paced exercise among overweight and obese adults: a randomized pilot study. Ann Behav Med. 2015 Apr;49(2):280-5. doi: 10.1007/s12160-014-9642-7.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- D0991
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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