Home Plate: A Trial to Improve Home Food Preparation Practices Among Parents of Toddlers
22 de abril de 2019 actualizado por: Children's Hospital of Philadelphia
Home Plate: A Randomized Controlled Trial of a Community-Engaged Intervention to Improve Home Food Preparation Practices and Health During Early Childhood
This study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children.
Descripción general del estudio
Descripción detallada
Barriers to healthy eating and active living are at the heart of the obesity epidemic. This study focuses on a key factor underlying healthy eating: home food preparation. This study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children. The investigators will partner with community-based organizations serving families with children ages 1 to 3 years in West Philadelphia aiming specifically to:
Test the intervention's effect on diet and physical health.
Hypothesis 1: The intervention group will have improved home food preparation practices and a healthier diet compared to the control group.
Test the intervention's effect on family health.
Hypothesis 2: The intervention group will report improved parenting skills and more hopeful patterns of thinking.
- Identify factors present at baseline and during engagement with the intervention that distinguish intervention participants who have improved diet, physical health, and family health from those who do not.
Tipo de estudio
Intervencionista
Inscripción (Actual)
115
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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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- The Children's Hospital of Philadelphia
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria: mentees
- English-speaking
- Able to give informed consent.
- Legal guardian and caregiver of at least one child, age 1-3 years
Inclusion Criteria: children
- 1-3 year old children of mentee primary caregivers enrolled in the study
- If a mentee caregiver has more than one child, then all their eligible children (ages 1-3 years) will be enrolled in the study.
Inclusion Criteria: peer mentors
Eligible peer mentors should meet the inclusion criteria set forth above for mentees. (Children of peer mentors will not be eligible for this study.)
In addition,
- The study team will decide which participants will be invited to be peer mentors, based on attributes including interest, leadership ability, and home food preparation skills.
Exclusion Criteria
- Caregivers and children not meeting the inclusion criteria above.
- Caregivers who are pregnant at the time of enrollment.
- Caregivers or children with a medical condition that significantly affects their diet or eating habits. (The study team will ask during the time of recruitment if subjects or their children have a medical condition that significantly affects diet or eating habits.)
- Subjects who, in the opinion of the Investigator, may be unable to participate in the study schedules or procedures.
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: 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: Intervention
Behavioral: Home Plate intervention
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Home Plate is a community-based, peer mentored intervention aimed at improving home food preparation practices in families with young children.
Through 6 classes, this intervention explores topics related to regularly preparing healthy foods at home.
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Experimental: Delayed Entry Control
This Arm will receive the Home Plate intervention 3 months after the Intervention Arm completes the intervention.
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Home Plate is a community-based, peer mentored intervention aimed at improving home food preparation practices in families with young children.
Through 6 classes, this intervention explores topics related to regularly preparing healthy foods at home.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Dietary Energy Density (Child Participants)
Periodo de tiempo: 19-30 weeks from baseline
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Child participants' 24-hour dietary recalls will be collected by trained study staff from adult caregivers.
24-hour dietary recalls will be collected on a minimum of 2 and a maximum of 3 separate days.
The results will then be used to calculate the energy density of the child's diet.
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19-30 weeks from baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Home Food Preparation Practices
Periodo de tiempo: 19-30 weeks from baseline
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Adult participants will complete surveys to assess the foods they usually prepare at home, as well as the time, energy, and confidence they have to prepare meals for their household.
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19-30 weeks from baseline
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Home Food Environment
Periodo de tiempo: 19-30 weeks from baseline
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Adult participants will complete surveys to assess the foods currently available in their homes, how they feel about managing food-related tasks, and the interactions they have with their child(ren) regarding food and eating.
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19-30 weeks from baseline
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Household Routines
Periodo de tiempo: 19-30 weeks from baseline
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Adult participants will complete surveys to assess their household routines related to activities such as sleep, physical activity, and screen time.
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19-30 weeks from baseline
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Emotional and Family Health
Periodo de tiempo: 19-30 weeks from baseline
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Adult participants will complete surveys to assess the their emotional health and the health of their families.
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19-30 weeks from baseline
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Body mass index
Periodo de tiempo: 19-30 weeks from baseline
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Heights and weights will be measured by trained study staff and will be used to calculate body mass index (BMI) of adult and child participants.
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19-30 weeks from baseline
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Dietary Energy Density (Adult Participants)
Periodo de tiempo: 19-30 weeks from baseline
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24-hour dietary recalls will be collected by trained study staff from adult study participants.
24-hour dietary recalls will be collected on a minimum of 2 and a maximum of 3 separate days.
The results will then be used to calculate dietary energy density.
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19-30 weeks from baseline
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Diet Quality
Periodo de tiempo: 19-30 weeks from baseline
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In addition to dietary energy density, 24-hour dietary recall data will be used to calculate both child and adult study participants' intake of fruits, vegetables, whole grains, and added sugars.
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19-30 weeks from baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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 2015
Finalización primaria (Actual)
1 de julio de 2017
Finalización del estudio (Actual)
13 de julio de 2017
Fechas de registro del estudio
Enviado por primera vez
28 de mayo de 2015
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2015
Publicado por primera vez (Estimar)
1 de junio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
22 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15-011720
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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 Home Plate
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University of MichiganActivo, no reclutandoSíntomas de comportamiento | Desordenes mentales | Desorden depresivo | Depresión | Trastornos del estado de ánimoEstados Unidos
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University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Terminado
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University of MichiganActivo, no reclutandoSíntomas de comportamiento | Desorden depresivo | Depresión | Trastornos del estado de ánimo | Trastorno mentalEstados Unidos
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University Health Network, TorontoSunnybrook Health Sciences Centre; University of TorontoActivo, no reclutando
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University Hospital, AngersTerminadoInfección de coronavirusFrancia
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Eling DeBruinTerminadoPrevención de caídas en el envejecimiento saludableSuiza
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University Health Network, TorontoReclutamientoLinfoma | Trastornos linfoproliferativos | Etapa I del cáncer de mama | Cáncer de mama en estadio II | Cáncer colorrectal en estadio II | Cáncer colorrectal en estadio III | Etapa III del cáncer de mama | Cáncer colorrectal Etapa I | Cáncer de cabeza y cuello estadio III | Cáncer de mama, estadio 0 | Cáncer... y otras condicionesCanadá
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University of North Carolina, Chapel HillNational Institute of Nursing Research (NINR)Terminado
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University of MinnesotaNational Heart, Lung, and Blood Institute (NHLBI); Allina Health System; Minneapolis...TerminadoActividad física | Obesidad, Infancia | La ingesta de alimentos | Salud RuralEstados Unidos