- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02399436
Appalachians Together Restoring the Eating Environment (Appal-TREE)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This pilot study evaluates two principal components of a community-based intervention to improve dietary habits and access to healthy foods: a school-based healthy snacking campaign and a series of community cooking classes for adults. The primary outcome assessed within each intervention component is dietary intake as measured by self-reported beverage and food consumption in pre-post surveys. Secondary outcome variables include attitudes, preferences, confidence, self-efficacy and other psychosocial variables related to healthy eating behaviors, perceptions of healthy food availability, food purchasing and preparation habits, and perceived barriers to healthy eating.
The school-based intervention component employs a nonequivalent control group research design. A subset of middle- and high-schools within a single county in eastern KY will receive a healthy snacking campaign intervention, and students from randomly selected classrooms within these schools will be invited to enroll in the study. Students from middle- and high-school classrooms in a comparison county that receives no intervention will serve as nonequivalent controls. The investigators specific aims for this component are to improve the availability of healthy snack foods that students may purchase at school, increase student consumption of healthy snacks over unhealthy snacks, and increase the consumption of water over sugar-sweetened beverages. Following baseline, posttest surveys will be administered at 3, 6 and 14 months.
Community cooking classes will be delivered to a non-random sample of adults who will complete pretest-posttest measures at baseline and 8 weeks. The specific aims of this component are to increase the consumption of healthy foods at home, and increase participant knowledge, skills, and self-efficacy around healthy home cooking.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40506
- University of Kentucky
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- For School-Based Component: 6th-12th grade students enrolled in a participating school and classroom in the intervention or comparison county.
- For Cooking Classes: Adults aged 18 years and older residing in intervention county who have at least one juvenile in household.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: School-Based Healthy Snacking Campaign
Students who attend middle and high schools in the experimental county that participate in the healthy snacking campaign intervention.
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The school-based healthy snacking campaign includes the following activities:
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Sin intervención: Comparison Schools
Students who attend middle and high schools in the comparison county, which does not receive any intervention components.
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Experimental: Community Cooking Classes
Adults in the intervention county who enroll in group cooking classes (single-group pretest-posttest)
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Cooking classes will be delivered to groups of 8-12 adult participants as a series of 8 weekly classes in community venues.
The content of each class is driven by topics and themes identified and prioritized by community members, namely cooking healthy on tight budget.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Beverage Consumption (Students)
Periodo de tiempo: Baseline, 3 months, 6 months, and 14 months
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Frequency and quantity of beverages consumed in past month.
Includes water, 100% fruit juice, sugar-sweetened beverages, sugar-free beverages and milk.
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Baseline, 3 months, 6 months, and 14 months
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Change in Snack Consumption (Students)
Periodo de tiempo: Baseline, 3 months, 6 months, and 14 months
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Frequency and quantity of snacks consumed in past month.
Includes chips (regular and low-fat), salty snacks, candy, desserts, vegetables, fruit, nuts and seeds, vegetable dips, yogurt, and popcorn.
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Baseline, 3 months, 6 months, and 14 months
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Change in Dietary intake (Adults)
Periodo de tiempo: Baseline to 8 weeks
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Frequency of consumption of fruits, vegetables, beans, candy, pastries, desserts, and salty snacks in the past month.
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Baseline to 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Snacking Attitudes and Preferences (Students)
Periodo de tiempo: Baseline, 3 months, 6 months, and 14 months
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Survey items address taste preferences, attitudes about healthy eating behaviors and body image
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Baseline, 3 months, 6 months, and 14 months
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Change in Healthy Snacking Confidence and Self-efficacy (Students)
Periodo de tiempo: Baseline, 3 months, 6 months, and 14 months
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Baseline, 3 months, 6 months, and 14 months
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Change in Availability of Healthy Snack Foods (Students)
Periodo de tiempo: Baseline, 3 months, 6 months, and 14 months
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Frequency of availability of healthy and unhealthy snack foods at school
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Baseline, 3 months, 6 months, and 14 months
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Change in Snack Food Purchasing Habits (Students)
Periodo de tiempo: Baseline, 3 months, 6 months, and 14 months
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Frequency of purchasing snack foods and beverages at fast food restaurants, convenience stores, and school venues and events
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Baseline, 3 months, 6 months, and 14 months
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Change in Food Preparation Habits (Adults)
Periodo de tiempo: Baseline to 8 weeks
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Likelihood of performing healthy food preparation behaviors; survey items address meal planning and preparation
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Baseline to 8 weeks
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Change in Food Purchasing Habits (Adults)
Periodo de tiempo: Baseline to 8 weeks
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Frequency of purchasing food at work, grocery/convenience stores, restaurants and produce stands
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Baseline to 8 weeks
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Change in Perceptions of Availability of Healthy Foods (Adults)
Periodo de tiempo: Baseline to 8 weeks
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Survey items address availability of high quality fruits and vegetables and low-fat foods
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Baseline to 8 weeks
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Change in Barriers to Healthy Eating (Adults)
Periodo de tiempo: Baseline to 8 weeks
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Survey items address physical, psychosocial, emotional, and financial barriers to healthy eating
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Baseline to 8 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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
Otros números de identificación del estudio
- 12-0900-P3H
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 School-Based Healthy Snacking Campaign
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Karolinska InstitutetSwedish Council for Working Life and Social Research; The Kamprad Family Foundation...TerminadoActividad física | Relaciones entre padres e hijos | Hábitos dietéticos | Sobrepeso y Obesidad | PrevenciónSuecia