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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02724839
Supporting Together Exercise and Play and Improving Nutrition (STEP IN)
13 de noviembre de 2020 actualizado por: Children's Hospital Medical Center, Cincinnati
Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care
The purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition sessions for primary care patients aged 6 -12 years who are overweight or obese and who want to eat healthier and be more active.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
In addition to the group nutrition sessions, the investigators will give a Fitbit to each of a parent and child dyad, which will be used to track and motivate their activity.
The investigators hypothesize an improvement pre-post in children's physical activity levels, self-efficacy and intentions for physical activity, self-reported consumption of fruits, vegetables, and child quality of life, and a decrease in consumption of sugar-sweetened beverages and fast and snack-food, and television (TV)/ videos screen time
Tipo de estudio
Intervencionista
Inscripción (Actual)
36
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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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Pediatric Primary Care Center (PPC) Cincinnati Children's Hospital Medical Center
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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
6 años a 12 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients whose primary medical home is the Pediatric Primary Care Center (primarily Medicaid or self-pay)
- BMI is greater than 85th%ile for age and sex
- English speaking
- have access to a computer/internet or a smart phone (for uploading Fitbit data)
Exclusion Criteria:
- Have been seen in a weight management clinic within the last 2 years
- prescribed an atypical antipsychotic
- non-ambulatory
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: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Biweekly Arm
6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session.
Sessions took place biweekly.
|
The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session.
Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson.
Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).
Otros nombres:
Parent and child dyads will each receive a Fitbit Flex wearable device at the second session.
This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
|
Experimental: Monthly Arm
6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session.
Sessions took place monthly.
|
The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session.
Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson.
Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).
Otros nombres:
Parent and child dyads will each receive a Fitbit Flex wearable device at the second session.
This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
|
Experimental: Weekly
6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session.
Sessions took place weekly.
|
The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session.
Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson.
Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).
Otros nombres:
Parent and child dyads will each receive a Fitbit Flex wearable device at the second session.
This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Attendance
Periodo de tiempo: Baseline, 3 months
|
Evaluation of participant attendance in each arm.
|
Baseline, 3 months
|
Overall Satisfaction With Group Nutrition Sessions
Periodo de tiempo: Baseline, 3 months
|
Participants evaluated their satisfaction with the group sessions using a 5 point scale with a score of 1 being complete dissatisfaction and 5 being the greatest satisfaction.
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Baseline, 3 months
|
Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.
Periodo de tiempo: Baseline, 3 months
|
Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases.
Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
|
Baseline, 3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
PedsQL (Pediatric Quality of Life Inventory)
Periodo de tiempo: Baseline, 3 months
|
Measure Description: PedsQL (Pediatric Quality of Life Inventory) is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related Quality of Life.
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Baseline, 3 months
|
BMI Z-Score
Periodo de tiempo: Baseline, 3 months
|
BMI Z-scores compares child to age and sex matched peers.
A z-score of 0 is the same as a 50th percentile in the reference population, a z-score of ± 1.0 plots at the 15th or 85th percentiles, respectively, and a z-score of ± 2 plots at roughly the 3rd or 97th percentiles.
Negative numbers indicate values lower than the reference population whereas positive numbers indicate values higher than the reference population.
|
Baseline, 3 months
|
Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)
Periodo de tiempo: baseline, 3 months
|
The description of the overall satisfaction variable is described in outcome #2 under primary outcomes.
|
baseline, 3 months
|
Child Self-efficacy Related to Physical Activity
Periodo de tiempo: Baseline, 3 months
|
Self efficacy was assessed using a validated 14-item questionnaire using a 5-point Strongly Agree/ Strongly Disagree scale.
The range of values is 1 to 5, with lower values indicating higher self-efficacy
|
Baseline, 3 months
|
Child Intention to be Active
Periodo de tiempo: baseline, 3 months
|
Child intention to be active was assessed with a 1-item questionnaire developed and validated by Saunders et al.
This item uses a 5-point scale, with possible range of scores being 1 to 5. Higher scores indicate greater intention to be active.
|
baseline, 3 months
|
Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily
Periodo de tiempo: Baseline, 3 months
|
Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases.
Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
|
Baseline, 3 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Kristen A Copeland, Children's Hospital Medical Center, Cincinnati
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.
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 (Actual)
1 de junio de 2015
Finalización primaria (Actual)
1 de octubre de 2018
Finalización del estudio (Actual)
1 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
14 de marzo de 2016
Primero enviado que cumplió con los criterios de control de calidad
25 de marzo de 2016
Publicado por primera vez (Estimar)
31 de marzo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
13 de noviembre de 2020
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2015-3406
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Descripción del plan IPD
This was a small, iterative feasibility study as a precursor to a larger clinical trial.
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
producto fabricado y exportado desde los 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. .
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