- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01912859
Next Steps: a Community-led Solution to Address Childhood Obesity
Next Steps: a Community-led Solution to Sustaining Healthy Behaviors in Families Addressing Childhood Obesity
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Next Steps is a community based pilot intervention study conducted in collaboration between community leaders, the University of Minnesota, Hennepin County Medical Center (HCMC) and The Family Partnership. The study collaborators will develop and test a new program designed to help low-income multiethnic families with overweight or obese children achieve long-term maintenance of healthful behaviors following completion of HCMC's 16-week intensive obesity management course (Taking Steps Together (TST)). Next Steps, the focus of this study, will comprise a network of parent-led, community-based health maintenance programs that will be offered to TST graduate families.
Project Aims:
Aim 1: Establish a core parent leadership group and health maintenance program network that is self-sustaining and can serve the community for years to come.
Aim 2: Test the feasibility, acceptability and sustainability of the Next Steps programs.
Aim 3: Assess the impact of the Next Steps programs on helping participant families sustain or improve healthful behaviors and achieve or maintain healthy body mass index (BMI).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Families that are graduates of the Taking Step Together program.
- Families with at least one overweight or obese child between the ages of 7-17.
- Family members of all ages who have graduated from the Taking Steps Together program will be included in the study.
Exclusion Criteria:
- Families who are not graduates of the Taking Steps Together program.
- Families who do not have one child that is between the ages of 7-17 and who is overweight or obese
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Nutrition/physical activity intervention
The intervention, Next Steps, comprises a network of community-led health maintenance programs offered to graduates of an initial intensive obesity course.
These health maintenance programs will aim to help participants maintain and improve healthful behaviors and body mass indices.
|
Nutrition/physical activity intervention
|
|
Sin intervención: Usual care
Participants in the "No Intervention" arm will not have access to the Next Steps programs and will receive only usual care through their health care clinic.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maintain or lower body mass index
Periodo de tiempo: up to 4 months
|
Body mass index.
|
up to 4 months
|
|
Frequency and intensity of physical activity
Periodo de tiempo: up to 4 months
|
Frequency and intensity of physical activity
|
up to 4 months
|
|
Frequency of intake of healthful foods and reduction of unhealthful foods;
Periodo de tiempo: up to 4 months
|
Frequency of intake of healthful foods and reduction of unhealthful foods;
|
up to 4 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chrisa Arcan, PhD, University of Minnesota
- Investigador principal: John D Anderson, MD, Hennepin County Medical Center, Minneapolis
- Investigador principal: Maria Galvan, Community Leader
- Investigador principal: Natividad Contreras, Community Leader
- Investigador principal: Aurolivia Reyes, Community Leader
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1303S29343
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. .