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

2018년 7월 6일 업데이트: 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.

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

중재적

등록 (실제)

644

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

7년 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 요인 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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
Fitbit 장치는 참가자의 걸음 수를 추적하는 무선 만보계로 참가자를 위한 맞춤형 정보가 포함된 맞춤형 웹사이트와 함께 제공됩니다.
다른 이름들:
  • Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity tracker
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
다른 이름들:
  • Rewards, gift vouchers
실험적: 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
Fitbit 장치는 참가자의 걸음 수를 추적하는 무선 만보계로 참가자를 위한 맞춤형 정보가 포함된 맞춤형 웹사이트와 함께 제공됩니다.
다른 이름들:
  • Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity tracker
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
다른 이름들:
  • Rewards, gift vouchers

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes in step count of parents from baseline to month 6, and month 12.
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Changes in step count of children from baseline to month 6, and month 12.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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

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간행물 및 유용한 링크

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2015년 11월 25일

기본 완료 (실제)

2018년 5월 28일

연구 완료 (실제)

2018년 6월 3일

연구 등록 날짜

최초 제출

2015년 4월 27일

QC 기준을 충족하는 최초 제출

2015년 8월 3일

처음 게시됨 (추정)

2015년 8월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 7월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 7월 6일

마지막으로 확인됨

2018년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • HSRG13may010

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