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

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ClinicalTrials.gov Identifier: NCT02516345
Recruitment Status : Completed
First Posted : August 5, 2015
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Eric A. Finkelstein, Duke-NUS Graduate Medical School

Tracking Information
First Submitted Date  ICMJE April 27, 2015
First Posted Date  ICMJE August 5, 2015
Last Update Posted Date July 10, 2018
Actual Study Start Date  ICMJE November 25, 2015
Actual Primary Completion Date May 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2018)
Changes in step count of parents from baseline to month 6, and month 12. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
Changes in moderate to vigorous physical activity (MVPA) bout minutes of parents from baseline to month 12. [ Time Frame: 12 months ]
MVPA bouts are defined as the total number of minutes during each 1-week assessment period in which moderate or vigorous activity of at least 8 of 10 consecutive minutes are reached. This will be assessed via the Actigraph GT3X-+ Triaxial Activity Monitor. We will measure "MVPA bouts" at baseline and 12 months. We hypothesize that parents in the CBI and FBI arms will record more "MVPA bouts" at 12 months than baseline. Furthermore, parents in the FBI arm will record more "MVPA bouts" at 12 months compared to parents in the CBI arm.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2018)
  • Changes in step count of children from baseline to month 6, and month 12. [ Time Frame: 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.
  • Changes in moderate to vigorous physical activity (MVPA) bout minutes of parents from baseline to month 6, and month 12. [ Time Frame: 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.
  • Changes in moderate to vigorous physical activity (MVPA) bout minutes of children from baseline to month 6, and month 12. [ Time Frame: 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.
  • Changes in moderate to vigorous physical activity (MVPA) minutes of parents from baseline to month 6, and month 12. [ Time Frame: 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).
  • Changes in moderate to vigorous physical activity (MVPA) minutes of children from baseline to month 6, and month 12. [ Time Frame: 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).
  • Changes in total volume of physical activity of parents from baseline to month 6 and month 12. [ Time Frame: 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.
  • Changes in total volume of physical activity of children from baseline to month 6 and month 12. [ Time Frame: 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.
  • Changes in sedentary behaviour of parents from baseline to month 6, and month 12. [ Time Frame: 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.
  • Changes in sedentary behaviour of children from baseline to month 6, and month 12. [ Time Frame: 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.
  • Changes in light minutes of parents from baseline to month 6, and month 12. [ Time Frame: 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.
  • Changes in light minutes of children from baseline to month 6, and month 12. [ Time Frame: 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.
  • Changes in total moderate minutes of parents from baseline to month 6 and month 12. [ Time Frame: 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.
  • Changes in total moderate minutes of children from baseline to month 6 and month 12. [ Time Frame: 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.
  • Changes in total vigorous minutes of parents from baseline to month 6, and month 12. [ Time Frame: 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.
  • Changes in total vigorous minutes of children from baseline to month 6, and month 12. [ Time Frame: 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.
  • Changes in daily average steps of parents over the 12 month study duration. [ Time Frame: Daily from months 1 - 12 ]
    Daily average steps will be calculated based on data captured by the Fitbit wireless pedometer.
  • Changes in daily average steps of children over the 12 month study duration. [ Time Frame: Daily from months 1 - 12 ]
    Daily average steps will be calculated based on data captured by the Fitbit wireless pedometer.
  • Changes in percentage of parents meeting weekly step targets over the 12 month study duration. [ Time Frame: Daily from months 1 - 12 ]
    Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
  • Changes in percentage of children meeting weekly step targets over the 12 month study duration. [ Time Frame: Daily from months 1 - 12 ]
    Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
  • Changes in percentage of parent-child dyads meeting weekly step targets over the 12 month study duration. [ Time Frame: Daily from months 1 - 12 ]
    Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
  • Change in weight of parents from baseline to month 6, and month 12. [ Time Frame: 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.
  • Change in systolic blood pressure of parents from baseline to month 6 and month 12. [ Time Frame: 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.
  • Change in cardiorespiratory fitness of parents from baseline to month 6, and month 12. [ Time Frame: 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.
  • Change in health-related quality of life of parents from baseline to month 6, and month 12. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
  • Changes in step count of parents from baseline to month 12. [ Time Frame: 12 months ]
    Step counts of parents will be measured via the ActiGraph GT-3x+ accelerometer worn for a one-week period at baseline and month 12.
  • Changes in total volume of physical activity of parents from baseline to month 12. [ Time Frame: 12 months ]
    Average daily volume of physical activity will be measured via the ActiGraph GT-3x+ accelerometer worn for a one-week period at baseline and month 12.
  • Changes in sedentary behaviour of parents from baseline to month 12. [ Time Frame: 12 months ]
    Average daily minutes of sedentary behaviour will be measured via the ActiGraph GT-3x+ accelerometer worn for a one-week period at baseline and month 12.
  • Changes in total light minutes of parents from baseline to month 12. [ Time Frame: 12 months ]
    Average daily light minutes will be measured via the ActiGraph GT-3x+ accelerometer worn for a one-week period at baseline and month 12.
  • Changes in total moderate minutes of parents from baseline to month 12. [ Time Frame: 12 months ]
    Average daily moderate minutes will be measured via the ActiGraph GT-3x+ accelerometer worn for a one-week period at baseline and month 12.
  • Changes in total vigorous minutes of parents from baseline to month 12. [ Time Frame: 12 months ]
    Average daily vigorous minutes will be measured via the ActiGraph GT-3x+ accelerometer worn for a one-week period at baseline and month 12.
  • Changes in step activity of parents over the 12 month study duration. [ Time Frame: 12 months ]
    Total weekly and daily average steps of parents, percentage of parents meeting weekly step targets, and number of weeks step target was achieved by parents will be calculated based on data captured by the Fitbit wireless pedometer.
  • Changes in step activity of children over the 12 month study duration. [ Time Frame: 12 months ]
    Total weekly and daily average steps of children, percentage of children meeting weekly step targets, and number of weeks step target was achieved by children will be calculated based on data captured by the Fitbit wireless pedometer.
  • Changes in step activity of parent-child pairs over the 12 month study duration. [ Time Frame: 12 months ]
    Percentage of parent-child pairs meeting weekly step targets and number of weeks step target was achieved by parent-child pairs will be calculated based on data captured by the Fitbit wireless pedometer.
  • Change in weight of parents from baseline to month 12. [ Time Frame: 12 months ]
    Weight of parents will be measured at baseline and month 12, and the difference will be calculated.
  • Change in systolic blood pressure of parents from baseline to month 12. [ Time Frame: 12 months ]
    Systolic blood pressure of parents will be measured at baseline and month 12, and the difference will be calculated.
  • Change in resting heart rate of parents from baseline to month 12. [ Time Frame: 12 months ]
    Resting heart rate of parents will be measured at baseline and month 12, and the difference will be calculated.
  • Change in cardiorespiratory fitness of parents from baseline to month 12. [ Time Frame: 12 months ]
    VO2max of parents will be measured at baseline and month 12, and the difference will be calculated.
  • Change in health-related quality of life of parents from baseline to month 12. [ Time Frame: 12 months ]
    Health-related quality of life of parents at baseline and month 12 will be measured via the EQ-5D-5L questionnaire.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial of an Incentive-based Physical Activity Program Targeting Both Children and Adults (FIT-FAM)
Official Title  ICMJE Randomized Controlled Trial of an Incentive-based Physical Activity Program Targeting Both Children and Adults (FIT-FAM)
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Physical Activity
Intervention  ICMJE
  • Device: Fitbit
    Fitbit devices are wireless pedometers that track the steps of participants, and will be offered in conjunction with a tailored website with customized information for participants.
    Other Name: Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity tracker
  • Behavioral: Incentives
    Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
    Other Name: Rewards, gift vouchers
Study Arms  ICMJE
  • Active Comparator: 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
    Interventions:
    • Device: Fitbit
    • Behavioral: Incentives
  • 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
    Interventions:
    • Device: Fitbit
    • Behavioral: Incentives
Publications * Finkelstein EA, Lim RSM, Ward DS, Evenson KR. Leveraging family dynamics to increase the effectiveness of incentives for physical activity: the FIT-FAM randomized controlled trial. Int J Behav Nutr Phys Act. 2020 Sep 10;17(1):113. doi: 10.1186/s12966-020-01018-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2017)
644
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2015)
640
Actual Study Completion Date  ICMJE June 3, 2018
Actual Primary Completion Date May 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02516345
Other Study ID Numbers  ICMJE HSRG13may010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric A. Finkelstein, Duke-NUS Graduate Medical School
Study Sponsor  ICMJE Duke-NUS Graduate Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Duke-NUS Graduate Medical School
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP