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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

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

    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45229
        • Pediatric Primary Care Center (PPC) Cincinnati Children's Hospital Medical Center

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:
  • Peer-led Group Sessions
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:
  • Peer-led Group Sessions
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:
  • Peer-led Group Sessions
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.
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.
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.

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

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. .

Ensayos clínicos sobre Group nutrition sessions

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