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临床试验/NCT02516345
NCT02516345
已完成
不适用

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

Duke-NUS Graduate Medical School1 个研究点 分布在 1 个国家目标入组 644 人2015年11月25日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Physical Activity
发起方
Duke-NUS Graduate Medical School
入组人数
644
试验地点
1
主要终点
Changes in step count of parents from baseline to month 6, and month 12.
状态
已完成
最后更新
7年前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2015年11月25日
结束日期
2018年6月3日
最后更新
7年前
研究类型
Interventional
研究设计
Factorial
性别
All

研究者

发起方
Duke-NUS Graduate Medical School
责任方
Principal Investigator
主要研究者

Eric A. Finkelstein

Professor

Duke-NUS Graduate Medical School

入排标准

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Changes in step count of parents from baseline to month 6, and month 12.

时间窗: 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.

次要结局

  • Changes in daily average steps of children over the 12 month study duration.(Daily from months 1 - 12)
  • Changes in moderate to vigorous physical activity (MVPA) bout minutes of children from baseline to 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.(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.(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.(Baseline, 6 months and 12 months)
  • Changes in step count of children from baseline to month 6, and month 12.(Baseline, 6 months and 12 months)
  • Changes in total volume of physical activity of parents from baseline to 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.(Baseline, 6 months and 12 months)
  • Changes in total volume of physical activity of children from baseline to 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.(Baseline, 6 months and 12 months)
  • Changes in light minutes of children from baseline to 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.(Baseline, 6 months and 12 months)
  • Changes in percentage of children meeting weekly step targets over the 12 month study duration.(Daily from months 1 - 12)
  • Change in systolic blood pressure of parents from baseline to month 6 and month 12.(Baseline, 6 months and 12 months)
  • Change in cardiorespiratory fitness of parents from baseline to month 6, and month 12.(Baseline, 6 months and 12 months)
  • Change in health-related quality of life of parents from baseline to month 6, and month 12.(Baseline, months and 12 months)
  • Changes in sedentary behaviour of children from baseline to 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.(Baseline, 6 months and 12 months)
  • Changes in total vigorous minutes of parents from baseline to month 6, and month 12.(Baseline, 6 months and 12 months)
  • Changes in percentage of parent-child dyads meeting weekly step targets over the 12 month study duration.(Daily from months 1 - 12)
  • Changes in total vigorous minutes of children from baseline to month 6, and month 12.(Baseline, 6 months and 12 months)
  • Changes in daily average steps of parents over the 12 month study duration.(Daily from months 1 - 12)
  • Changes in percentage of parents meeting weekly step targets over the 12 month study duration.(Daily from months 1 - 12)
  • Change in weight of parents from baseline to month 6, and month 12.(Baseline, 6 months and 12 months)

研究点 (1)

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