- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02586467
Messages for Increasing Dairy Consumption (MilkMessage)
22 de octubre de 2015 actualizado por: Mary Jung, University of British Columbia
Testing the Effectiveness of Targeted, Framed, -Efficacy Enhancing Messages for Increasing Milk and Milk Product Consumption in Adults Aged 30--50 Years.
Over 35,000 Canadians, 65% of men and 72% of women aged 31-50 years fail to consume the recommended number of milk and milk product servings (≤2 servings per day).
Given the wide range of health benefits associated with increased dietary intake of milk and milk products the objectives of this study were to conduct a prospective, 5-arm randomised controlled trial in order to test the effectiveness of a variety of messages for increasing milk and milk product consumption in men and women aged 30-50 years old.
The five arms consisted of 4 messages that contained slightly different content specifically: 1) gain-framed message condition, 2) loss-framed message condition, 3) self-regulatory efficacy-enhancing message condition, 4) gain-framed and self-regulatory efficacy-enhancing message condition and 5) loss-framed plus self-regulatory efficacy-enhancing message condition.
It was hypothesised that those who receive self-regulatory efficacy-enhancing information would consume more dairy than those who received messages without such information.
Second, those who received gain-framed messages would consume more dairy as compared to those who received loss-framed messages.
Third, those who received gain-framed messages that include self-regulatory efficacy-enhancing information would consume the most dairy in comparison to the other four conditions.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
732
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
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British Columbia
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Kelowna, British Columbia, Canadá, V1V 1V7
- Health and Exercise Psychology Laboratory
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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
30 años a 50 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Between 30 and 50 years of age
- Consume less than 2 servings of milk or milk products per day
- No health or religious reasons to avoid milk and milk products
- Regular access to the internet
- Can speak and read English
Exclusion Criteria:
- Dietary restrictions, allergies, or medical reasons for limiting dairy intake will be excluded
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: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Gain-Framed
Participants receive messages that highlight the potential benefits of engaging in a specific behaviour (i.e., what positive outcomes they could experience from consuming milk and milk products).
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Participants will be randomised to one of five message conditions.
Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day).
Participants in the Gain-Framed message condition will receive message content that highlights the potential benefits of consuming milk and milk products (i.e., high protein content, stronger hair and nail etc.)
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Experimental: Loss-Framed
Participants receive messages that highlight the potentially loses of not engaging in a specific behaviour (i.e., what they could lose from not consuming milk and milk products).
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Participants will be randomised to one of five message conditions.
Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day).
Participants in the Loss-Framed message condition will receive message content that highlights the potential losses of not consuming milk and milk products (i.e., lack of essential nutrients, less calcium).
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Experimental: Self-Regulatory Efficacy
Participants receive messages that provide them with tips and strategies on how to engage in the consumption of milk and milk products (i.e., recipes, meal planning etc.)
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Participants will be randomised to one of five message conditions.
Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day).
Participants in the Self-Regulatory Efficacy message condition will receive information pertaining to how to include milk and milk products within their diet.
This information will come in the form of recipes, meal planning, food combining etc.
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Experimental: Gain-Framed + Self-Regulatory Efficacy
Participants receive messages that highlight the potential benefits of engaging in a specific behaviour (i.e., what positive outcomes they could experience from consuming milk and milk products) and these messages also provide tips and strategies on how to engage in the consumption of milk and milk products (i.e., recipes, meal planning etc.).
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Participants will be randomised to one of five message conditions.
Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day).
Participants in the Gain-Framed message + Self-Regulatory Efficacy condition will receive message content that highlights the potential benefits of consuming milk and milk products (i.e., high protein content, stronger hair and nail etc.) and information pertaining to how to include milk and milk products within their diet.
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Experimental: Loss-Framed + Self-Regulatory Efficacy
Participants receive messages that highlight the potentially loses of not engaging in a specific behaviour (i.e., what they could lose from not consuming milk and milk products) and these messages also provide tips and strategies on how to engage in the consumption of milk and milk products (i.e., recipes, meal planning etc.).
|
Participants will be randomised to one of five message conditions.
Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day).
Participants in the Loss-Framed message + Self-Regulatory Efficacy condition will receive message content that highlights the potential losses of not consuming milk and milk products (i.e., lack of essential nutrients, less calcium) and information pertaining to how to include milk and milk products within their diet.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes from baseline in calcium from dairy at 1 and 4-week follow up
Periodo de tiempo: Baseline, 1-week follow-up, 4-week follow-up
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Calcium consumed from dairy was assessed using a modified version of the "Calcium Calculator™" developed by the British Columbia Dairy Foundation.
The original tool assesses consumption of calcium from a comprehensive list of 30 commonly consumed calcium containing products.
For this study individuals were asked to indicate the portions they ate of 10 dairy products included in the list.
An explanation of a portion was provided for each item.
Milligrams of calcium consumed by participants on the previous day was determined for baseline, week 1 and week 4 follow-up.
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Baseline, 1-week follow-up, 4-week follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-Regulatory Efficacy
Periodo de tiempo: Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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Changes in participants self-regulatory efficacy beliefs was assessed using an 18-item measure at baseline, 1-day after completion of the intervention and at 4-week follow-up.
Self-regulatory efficacy beliefs items were context specific.
Responses were scored on a scale of 0% (not at all) to 100% (extremely confident) with response options in 10% increments.
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Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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Outcome Expectations
Periodo de tiempo: Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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Changes in participants outcome expectations was assessed at baseline, 1-day after completion of the intervention and at 4-week follow-up.
The perceived likelihood of positive (16 items) and negative (5 items) outcomes occurring as a result of consuming milk and milk products was assessed using a 21-item measure.
Responses were scored on a 9-point scale from 1 (very unlikely) to 9 (very likely).
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Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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Outcome Values
Periodo de tiempo: Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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Changes in participants outcome values was assessed at baseline, 1-day after completion of the intervention and at 4-week follow-up.
The perceived value of positive (16 items) and negative (5 items) outcomes occurring as a result of consuming milk and milk products was assessed using a 21-item measure.
Responses were scored on a 9-point scale with a range of 1 (little value to me) to 9 (high value to me).
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Baseline, Immedately after the Intervention (1-day), 4-Week Follow-Up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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.
Publicaciones Generales
- Tversky A, Kahneman D. The framing of decisions and the psychology of choice. Science. 1981 Jan 30;211(4481):453-8. doi: 10.1126/science.7455683.
- Jung ME, Martin Ginis KA, Phillips SM, Lordon CD. Increasing calcium intake in young women through gain-framed, targeted messages: a randomised controlled trial. Psychol Health. 2011 May;26(5):531-47. doi: 10.1080/08870441003611544.
- Bandura A. Social foundations of thought and action: A social cognitive theory. NJ US: Prentice-Hall, Inc; 1986.
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 agosto de 2013
Finalización primaria (Actual)
1 de noviembre de 2013
Finalización del estudio (Actual)
1 de noviembre de 2013
Fechas de registro del estudio
Enviado por primera vez
20 de octubre de 2015
Primero enviado que cumplió con los criterios de control de calidad
22 de octubre de 2015
Publicado por primera vez (Estimar)
26 de octubre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
26 de octubre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
22 de octubre de 2015
Última verificación
1 de octubre de 2015
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- H12-00332
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. .