Randomized Controlled Trial of an Incentive-based Physical Activity Program Targeting Both Children and Adults (FIT-FAM) (FIT-FAM)
6 de julho de 2018 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
644
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Singapore, Cingapura, 169857
- Duke-NUS Medical School
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
7 anos a 65 anos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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:
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Os dispositivos Fitbit são pedômetros sem fio que rastreiam os passos dos participantes e serão oferecidos em conjunto com um site personalizado com informações personalizadas para os participantes.
Outros nomes:
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
Outros nomes:
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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:
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Os dispositivos Fitbit são pedômetros sem fio que rastreiam os passos dos participantes e serão oferecidos em conjunto com um site personalizado com informações personalizadas para os participantes.
Outros nomes:
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in step count of parents from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in step count of children from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in moderate to vigorous physical activity (MVPA) bout minutes of parents from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in moderate to vigorous physical activity (MVPA) bout minutes of children from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in moderate to vigorous physical activity (MVPA) minutes of parents from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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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).
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Baseline, 6 months and 12 months
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Changes in moderate to vigorous physical activity (MVPA) minutes of children from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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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).
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Baseline, 6 months and 12 months
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Changes in total volume of physical activity of parents from baseline to month 6 and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in total volume of physical activity of children from baseline to month 6 and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in sedentary behaviour of parents from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in sedentary behaviour of children from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in light minutes of parents from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in light minutes of children from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in total moderate minutes of parents from baseline to month 6 and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in total moderate minutes of children from baseline to month 6 and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in total vigorous minutes of parents from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in total vigorous minutes of children from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in daily average steps of parents over the 12 month study duration.
Prazo: Daily from months 1 - 12
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Daily average steps will be calculated based on data captured by the Fitbit wireless pedometer.
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Daily from months 1 - 12
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Changes in daily average steps of children over the 12 month study duration.
Prazo: Daily from months 1 - 12
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Daily average steps will be calculated based on data captured by the Fitbit wireless pedometer.
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Daily from months 1 - 12
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Changes in percentage of parents meeting weekly step targets over the 12 month study duration.
Prazo: Daily from months 1 - 12
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Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
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Daily from months 1 - 12
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Changes in percentage of children meeting weekly step targets over the 12 month study duration.
Prazo: Daily from months 1 - 12
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Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
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Daily from months 1 - 12
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Changes in percentage of parent-child dyads meeting weekly step targets over the 12 month study duration.
Prazo: Daily from months 1 - 12
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Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
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Daily from months 1 - 12
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Change in weight of parents from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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Weight of parents will be measured at baseline, month 6, and month 12, and the difference will be calculated.
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Baseline, 6 months and 12 months
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Change in systolic blood pressure of parents from baseline to month 6 and month 12.
Prazo: Baseline, 6 months and 12 months
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Systolic blood pressure of parents will be measured at baseline, month 6, and month 12, and the difference will be calculated.
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Baseline, 6 months and 12 months
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Change in cardiorespiratory fitness of parents from baseline to month 6, and month 12.
Prazo: Baseline, 6 months and 12 months
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VO2max of parents will be measured at baseline, month 6, and month 12, and the difference will be calculated.
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Baseline, 6 months and 12 months
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Change in health-related quality of life of parents from baseline to month 6, and month 12.
Prazo: Baseline, months and 12 months
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Health-related quality of life of parents at baseline, month 6, and month 12 will be measured via the EQ-5D-5L questionnaire.
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Baseline, months and 12 months
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Colaboradores e Investigadores
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
25 de novembro de 2015
Conclusão Primária (Real)
28 de maio de 2018
Conclusão do estudo (Real)
3 de junho de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
27 de abril de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de agosto de 2015
Primeira postagem (Estimativa)
5 de agosto de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de julho de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de julho de 2018
Última verificação
1 de julho de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- HSRG13may010
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .