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Randomized Controlled Trial of an Incentive-based Physical Activity Program Targeting Both Children and Adults (FIT-FAM) (FIT-FAM)

6 de julio de 2018 actualizado por: Eric A. Finkelstein, Duke-NUS Graduate Medical School
This study aims to test whether incentives can motivate children to promote increased physical activity of a working parent while also increasing their own activity levels.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

There is overwhelming evidence that sustained physical activity reduces the risk of many common diseases. Yet, data reveal low levels of physical activity among working age adults and their children in Singapore. One strategy that has been successfully employed to influence behaviours of parents is to use their children as an intermediary. This strategy has a successful track record in public health, where children have helped their parents quit smoking and wear seatbelts.

In this study, the investigators propose to test whether children can promote increased physical activity of a working parent at the same time that they increase their own activity level. This proposal is an extension of a prior study where the investigators showed that modest financial incentives can increase physical activity levels among children. The investigators now propose to conduct a follow-on trial where the reward is tied not only to the child's own steps, but to that of a parent. Rewards will be based on step activity measured through a state-of-the-art wireless step counter worn on the wrist or hip. Just as children were motivated to increase their own activity levels in efforts to achieve the incentive, the investigators hypothesize that they will also be effective advocates for increasing the activity levels of their parents.

Specifically, the investigators propose to conduct a 12 month two-arm randomized controlled trial (RCT) to evaluate the efficacy of the family based incentive scheme on working parents' physical activity as measured via accelerometry. The investigators hypothesize that parents in the family-based incentive arm (FBI) will show a greater number of daily steps at the interim 6 month assessment and the final 12 month assessment point compared to parents in the child based incentive (CBI) arm, as measured by accelerometry. Secondary aims test the effects of the intervention on parent's and child's MVPA bout minutes per week, MVPA minutes, and other physical activity endpoints measured by accelerometry, child's steps, parent's and child's activity levels throughout the intervention period measured by the pedometer, and on health outcomes and health-related quality of life of parents at follow-up.

Tipo de estudio

Intervencionista

Inscripción (Actual)

644

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

  • Singapur
      • Singapore, Singapur, 169857
        • Duke-NUS Medical School

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

7 años a 65 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Child must be aged 7 - 11 years
  • Parent must be aged 25 - 65 years
  • Parent must be full-time employee at the time of enrolment
  • Parent should be Singaporean citizen or permanent resident
  • Parent and child must provide at least 4 valid days of accelerometer data (3 weekday days and 1 weekend day of at least 10 hours of wear time each day)

Exclusion Criteria:

  • Difficulty walking up 10 stairs without stopping (for parents)
  • Having any medical condition that may limit their ability to walk as a means of physical activity (for parents)
  • Pregnant (for parents)
  • Are unwilling to wear a wireless pedometer for 12 months (for parents and children)
  • Are unwilling to wear an accelerometer for 1 week at baseline, month 6, and month 12 assessments (for parents and children)

Conditional Eligibility Criteria:

If parents meet the following criteria, they will be required to provide an approval note from a physician to be able to participate in the study-

  • Self-reported medical conditions such as hypertension or diabetes that limit the ability to walk
  • Answer 'YES' to any Physical Activity Readiness (PAR-Q) question
  • Family history of heart conditions
  • BMI>40kg/m2
  • Children on whose behalf parents answer 'YES' to any PAR-Q question will be permitted to enrol only if they provide written approval from a medical doctor

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: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Child-based Incentive (CBI)

Children earn rewards each week (with the week beginning on Monday and ending on Sunday) that they log 10,000 daily steps on the Fitbit according to the schedule below and their matched parent logs at least 2,000 steps on ≥4 of 7 days each week (regardless of which 4 of the 7 days they wear it). Incentives are tied, in addition to child's activity, to parent's Fitbit wear so that the investigators are better able to capture parent's activity in this arm.

Step Targets for Children in CBI arm:

  • Months 1 - 3: ≥10,000 daily steps on ≥4 out of 7 days each week
  • Months 4 - 6: ≥10,000 daily steps on ≥5 out of 7 days each week
  • Months 7 - 12: ≥10,000 daily steps on ≥6 out of 7 days each week
Dispositivo: Fitbit
Los dispositivos Fitbit son podómetros inalámbricos que rastrean los pasos de los participantes y se ofrecerán junto con un sitio web personalizado con información personalizada para los participantes.
Otros nombres:
  • Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity tracker
Conductual: Incentives
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
Otros nombres:
  • Rewards, gift vouchers
Experimental: Family-based Incentive (FBI)

Children earn rewards each week that they log daily steps on the Fitbit according to the schedule below but only if their matched parent also logs 10,000 steps according to the schedule below. Otherwise, children earn no incentive for that week.

Step targets for children and parents in FBI arm:

  • Months 1 - 3: ≥10,000 daily steps on ≥4 out of 7 days each week
  • Months 4 - 6: ≥10,000 daily steps on ≥5 out of 7 days each week
  • Months 7 - 12: ≥10,000 daily steps on ≥6 out of 7 days each week
Dispositivo: Fitbit
Los dispositivos Fitbit son podómetros inalámbricos que rastrean los pasos de los participantes y se ofrecerán junto con un sitio web personalizado con información personalizada para los participantes.
Otros nombres:
  • Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity tracker
Conductual: Incentives
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
Otros nombres:
  • Rewards, gift vouchers

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in step count of parents from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Step counts of parents will be measured via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, month 6, and month 12.
Baseline, 6 months and 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in step count of children from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Step counts of children will be measured via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, month 6, and month 12.
Baseline, 6 months and 12 months
Changes in moderate to vigorous physical activity (MVPA) bout minutes of parents from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
MVPA will be assessed via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, 6 months, and 12 months. MVPA bout minutes are defined as a total of 10 or more consecutive minutes above the vector magnitude cutoff point of 2690 counts per min, with allowance for interruptions of 1-2 min at a magnitude less than the cutoff point.
Baseline, 6 months and 12 months
Changes in moderate to vigorous physical activity (MVPA) bout minutes of children from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
MVPA will be assessed via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, 6 months, and 12 months. MVPA bout minutes are defined as a total of 10 or more consecutive minutes above the vector magnitude cutoff point of 2690 counts per min, with allowance for interruptions of 1-2 min at a magnitude less than the cutoff point.
Baseline, 6 months and 12 months
Changes in moderate to vigorous physical activity (MVPA) minutes of parents from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Total MVPA minutes (including those not in bouts of 10 minutes) during each assessment period at baseline, month 6, and month 12. This will be assessed via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day).
Baseline, 6 months and 12 months
Changes in moderate to vigorous physical activity (MVPA) minutes of children from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Total MVPA minutes (including those not in bouts of 10 minutes) during each assessment period at baseline, month 6, and month 12. This will be assessed via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day).
Baseline, 6 months and 12 months
Changes in total volume of physical activity of parents from baseline to month 6 and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Average daily volume of physical activity will be measured via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, month 6, and month 12.
Baseline, 6 months and 12 months
Changes in total volume of physical activity of children from baseline to month 6 and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Average daily volume of physical activity will be measured via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, month 6, and month 12.
Baseline, 6 months and 12 months
Changes in sedentary behaviour of parents from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Average daily minutes of sedentary behaviour will be measured via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, month 6, and month 12.
Baseline, 6 months and 12 months
Changes in sedentary behaviour of children from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Average daily minutes of sedentary behaviour will be measured via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, month 6, and month 12.
Baseline, 6 months and 12 months
Changes in light minutes of parents from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Average daily light minutes will be measured via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, month 6, and month 12.
Baseline, 6 months and 12 months
Changes in light minutes of children from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Average daily light minutes will be measured via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, month 6, and month 12.
Baseline, 6 months and 12 months
Changes in total moderate minutes of parents from baseline to month 6 and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Average daily moderate minutes will be measured via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, month 6, and month 12.
Baseline, 6 months and 12 months
Changes in total moderate minutes of children from baseline to month 6 and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Average daily moderate minutes will be measured via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, month 6, and month 12.
Baseline, 6 months and 12 months
Changes in total vigorous minutes of parents from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Average daily vigorous minutes will be measured via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, month 6, and month 12.
Baseline, 6 months and 12 months
Changes in total vigorous minutes of children from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Average daily vigorous minutes will be measured via the ActiGraph GT-3X+ accelerometer worn for a one-week period (with a minimum of 3 weekday days and 1 weekend day of at least 10 hours of wear time each day) at baseline, month 6, and month 12.
Baseline, 6 months and 12 months
Changes in daily average steps of parents over the 12 month study duration.
Periodo de tiempo: Daily from months 1 - 12
Daily average steps will be calculated based on data captured by the Fitbit wireless pedometer.
Daily from months 1 - 12
Changes in daily average steps of children over the 12 month study duration.
Periodo de tiempo: Daily from months 1 - 12
Daily average steps will be calculated based on data captured by the Fitbit wireless pedometer.
Daily from months 1 - 12
Changes in percentage of parents meeting weekly step targets over the 12 month study duration.
Periodo de tiempo: Daily from months 1 - 12
Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
Daily from months 1 - 12
Changes in percentage of children meeting weekly step targets over the 12 month study duration.
Periodo de tiempo: Daily from months 1 - 12
Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
Daily from months 1 - 12
Changes in percentage of parent-child dyads meeting weekly step targets over the 12 month study duration.
Periodo de tiempo: Daily from months 1 - 12
Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
Daily from months 1 - 12
Change in weight of parents from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Weight of parents will be measured at baseline, month 6, and month 12, and the difference will be calculated.
Baseline, 6 months and 12 months
Change in systolic blood pressure of parents from baseline to month 6 and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
Systolic blood pressure of parents will be measured at baseline, month 6, and month 12, and the difference will be calculated.
Baseline, 6 months and 12 months
Change in cardiorespiratory fitness of parents from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, 6 months and 12 months
VO2max of parents will be measured at baseline, month 6, and month 12, and the difference will be calculated.
Baseline, 6 months and 12 months
Change in health-related quality of life of parents from baseline to month 6, and month 12.
Periodo de tiempo: Baseline, months and 12 months
Health-related quality of life of parents at baseline, month 6, and month 12 will be measured via the EQ-5D-5L questionnaire.
Baseline, months and 12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Duke-NUS Graduate Medical School

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.

Publicaciones Generales

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)

25 de noviembre de 2015

Finalización primaria (Actual)

28 de mayo de 2018

Finalización del estudio (Actual)

3 de junio de 2018

Fechas de registro del estudio

Enviado por primera vez

27 de abril de 2015

Primero enviado que cumplió con los criterios de control de calidad

3 de agosto de 2015

Publicado por primera vez (Estimar)

5 de agosto de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de julio de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

6 de julio de 2018

Última verificación

1 de julio de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • HSRG13may010

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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