Do Weight Status and the Level of Dietary Restraint Moderate the Relationship Between Package Unit Size and Food Intake?
3 de abril de 2018 actualizado por: Hollie Raynor, The University of Tennessee, Knoxville
The objective of this study is to determine the independent and combined effects of weight status and the level of dietary restraint on the relationship between package unit size and food intake.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The estimated prevalence of obesity among adults in 2007-2008 was 33.8% and the combined estimated prevalence of overweight and obesity was 68.0% [1]. Although there are no clear reasons for the current obesity epidemic, there is a general consensus that environmental dietary factors, such as package unit size, encourage excessive food intake and positive energy balance [2, 3]. It is believed that the package unit size of food indirectly influences food intake by impacting the accuracy of consumption monitoring [2, 4]. Large packages decrease the accuracy of consumption monitoring by making it difficult to assess how many servings have been consumed in one sitting, while small single-serving packages can increase the accuracy of consumption monitoring by providing a clear definition of what a standard serving is and how much one has consumed [2, 4, 5]. Therefore, it has been proposed that small, single-serving packages of snack foods may help reduce energy intake [4, 5]. To date, limited studies have been conducted in this area and the results are inconsistent [4-9]. Mixed results could be related to differences in participant variables, specifically weight status and level of dietary restraint (a term that refers to the amount of control exerted over food intake) [4, 9]. These individual characteristics may interact with food package unit size to influence one's food intake [2, 4]. Overweight individuals or restrained eaters may more closely monitor the volume of food they consume as compared to normal weight or unrestrained eaters [4, 9]. The [smaller] size of food packaging may aid in monitoring food consumption and thus, influence how much food is consumed in overweight and/or restrained eaters [2, 4]. Therefore, the objective of this study is to determine if weight status and the level of dietary restraint moderate the relationship between package unit size and food intake.
Specific Aims:
- Determine the effect of dietary restraint on the relationship between package unit size and food intake.
- Determine the effect of weight status on the relationship between package unit size and food intake.
- Determine the combined effect of weight status and dietary restraint on the relationship between package unit size and food intake.
Tipo de estudio
Intervencionista
Inscripción (Actual)
64
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
-
-
Tennessee
-
Knoxville, Tennessee, Estados Unidos, 37996
- Healthy Eating and Activity Laboratory
-
-
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 35 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male and females aged 18-35 years old.
Body Mass Index (BMI) between 18.5-24.9 kg/m2 or BMI between 25-39.9 kg/m2.
- For normal weight groups: BMI of 18.5-24.9 kg/m2.
- For overweight groups: BMI of 25-39.9 kg/m2.
Dietary restraint scores of either less than or equal to 12 or > 12 on the Three Factor Eating Questionnaire-Cognitive Restraint scale (TFEQ-R) [10].
- For unrestrained groups: less than or equal to 12.
- For restrained groups: > 12.
- Do not have unfavorable preference toward pretzels.
- Do not have allergies to pretzel ingredients.
- Do not have a health condition or use medication that affects eating or requires a therapeutic diet.
- Must have a consistent schedule during the time of the study.
- Must agree to instructions to not share pretzel snack packages with others.
Exclusion Criteria:
- BMI below 18.5 or above 39.9 kg/m2.
- Have an unfavorable preference toward pretzels.
Have allergies to pretzel ingredients (wheat flour).
- Severe allergies to nuts - Synder's of Hanover pretzels are made in a facility that handles peanut butter.
- Are unwilling to consume pretzels during the time of the study.
- Are pregnant or breastfeeding.
- Do not meet one or more of the other above mentioned eligibility requirements.
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Normal Weight, Unrestrained - Standard
Each participant is of normal weight (BMI: 18.5-24.9
kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
|
Participants will receive a box of two, 10-oz.
packages of pretzels.
Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days.
Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
|
|
Comparador activo: Normal Weight, Restrained - Single Serving
Each participant is of normal weight (BMI: 18.5-24.9
kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
|
Participants will receive a box of twenty-two, 0.9-oz.
packages of pretzels.
Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days.
Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
|
|
Comparador activo: Normal Weight, Restrained - Standard
Each participant is of normal weight (BMI: 18.5-24.9
kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
|
Participants will receive a box of two, 10-oz.
packages of pretzels.
Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days.
Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
|
|
Comparador activo: Overweight, Unrestrained - Single Serving
Each participant is overweight (BMI: 25-39.9
kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
|
Participants will receive a box of twenty-two, 0.9-oz.
packages of pretzels.
Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days.
Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
|
|
Comparador activo: Overweight, Unrestrained - Standard
Each participant is overweight (BMI: 25-39.9
kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
|
Participants will receive a box of two, 10-oz.
packages of pretzels.
Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days.
Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
|
|
Comparador activo: Overweight, Restrained - Single Serving
Each participant is overweight (BMI: 25-39.9
kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
|
Participants will receive a box of twenty-two, 0.9-oz.
packages of pretzels.
Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days.
Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
|
|
Comparador activo: Overweight, Restrained - Standard
Each participant is overweight (BMI: 25-39.9
kg/m2) and is classified as a restrained eater (scoring greater than 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
|
Participants will receive a box of two, 10-oz.
packages of pretzels.
Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days.
Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
|
|
Comparador activo: Normal Weight, Unrestrained - Single Serving
Each participant is of normal weight (BMI: 18.5-24.9
kg/m2) and is classified as an unrestrained eater (scoring less than or equal to 12 on the Three Factor Eating Questionnaire - Cognitive Restraint Scale).
|
Participants will receive a box of twenty-two, 0.9-oz.
packages of pretzels.
Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days.
Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total grams of pretzels consumed.
Periodo de tiempo: 4 days
|
Total grams of pretzels consumed by participants over the 4-day study period will be determined by subtracting pre- and post-consumption weight of snack packages provided.
|
4 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Hollie A Raynor, Ph.D., University of Tennessee, Knoxville
- Investigador principal: Chrystal L Haire, B.S., University of Tennessee, Knoxville
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
- Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.
- Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.
- French SA, Story M, Jeffery RW. Environmental influences on eating and physical activity. Annu Rev Public Health. 2001;22:309-35. doi: 10.1146/annurev.publhealth.22.1.309.
- Wansink B. Environmental factors that increase the food intake and consumption volume of unknowing consumers. Annu Rev Nutr. 2004;24:455-79. doi: 10.1146/annurev.nutr.24.012003.132140.
- Raynor HA, Wing RR. Package unit size and amount of food: do both influence intake? Obesity (Silver Spring). 2007 Sep;15(9):2311-9. doi: 10.1038/oby.2007.274.
- Stroebele N, Ogden LG, Hill JO. Do calorie-controlled portion sizes of snacks reduce energy intake? Appetite. 2009 Jun;52(3):793-796. doi: 10.1016/j.appet.2009.02.015. Epub 2009 Mar 6.
- Devitt AA, Mattes RD. Effects of food unit size and energy density on intake in humans. Appetite. 2004 Apr;42(2):213-20. doi: 10.1016/j.appet.2003.10.003.
- Raynor HA, Van Walleghen EL, Niemeier H, Butryn ML, Wing RR. Do food provisions packaged in single-servings reduce energy intake at breakfast during a brief behavioral weight-loss intervention? J Am Diet Assoc. 2009 Nov;109(11):1922-5. doi: 10.1016/j.jada.2009.08.009.
- Freedman MR, Brochado C. Reducing portion size reduces food intake and plate waste. Obesity (Silver Spring). 2010 Sep;18(9):1864-6. doi: 10.1038/oby.2009.480. Epub 2009 Dec 24.
- Wansink B, Payne CR, Shimizu M. The 100-calorie semi-solution: sub-packaging most reduces intake among the heaviest. Obesity (Silver Spring). 2011 May;19(5):1098-100. doi: 10.1038/oby.2010.306. Epub 2011 Jan 13.
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 junio de 2011
Finalización primaria (Actual)
1 de octubre de 2011
Finalización del estudio (Actual)
1 de octubre de 2011
Fechas de registro del estudio
Enviado por primera vez
25 de junio de 2011
Primero enviado que cumplió con los criterios de control de calidad
27 de junio de 2011
Publicado por primera vez (Estimar)
29 de junio de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de abril de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
3 de abril de 2018
Última verificación
1 de abril de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 8573 B
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. .