Physical Activity Clinical Trial
— FIT-FAMOfficial title:
Randomized Controlled Trial of an Incentive-based Physical Activity Program Targeting Both Children and Adults (FIT-FAM)
Verified date | July 2018 |
Source | Duke-NUS Graduate Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 644 |
Est. completion date | June 3, 2018 |
Est. primary completion date | May 28, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Duke-NUS Medical School | Singapore |
Lead Sponsor | Collaborator |
---|---|
Duke-NUS Graduate Medical School |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in step count of parents from baseline to month 6, and month 12. | 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 | |
Secondary | Changes in step count of children from baseline to month 6, and month 12. | 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 | |
Secondary | Changes in moderate to vigorous physical activity (MVPA) bout minutes of parents from baseline to month 6, and month 12. | 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 | |
Secondary | Changes in moderate to vigorous physical activity (MVPA) bout minutes of children from baseline to month 6, and month 12. | 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 | |
Secondary | Changes in moderate to vigorous physical activity (MVPA) minutes of parents from baseline to month 6, and month 12. | 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 | |
Secondary | Changes in moderate to vigorous physical activity (MVPA) minutes of children from baseline to month 6, and month 12. | 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 | |
Secondary | Changes in total volume of physical activity of parents from baseline to month 6 and month 12. | 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 | |
Secondary | Changes in total volume of physical activity of children from baseline to month 6 and month 12. | 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 | |
Secondary | Changes in sedentary behaviour of parents from baseline to month 6, and month 12. | 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 | |
Secondary | Changes in sedentary behaviour of children from baseline to month 6, and month 12. | 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 | |
Secondary | Changes in light minutes of parents from baseline to month 6, and month 12. | 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 | |
Secondary | Changes in light minutes of children from baseline to month 6, and month 12. | 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 | |
Secondary | Changes in total moderate minutes of parents from baseline to month 6 and month 12. | 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 | |
Secondary | Changes in total moderate minutes of children from baseline to month 6 and month 12. | 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 | |
Secondary | Changes in total vigorous minutes of parents from baseline to month 6, and month 12. | 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 | |
Secondary | Changes in total vigorous minutes of children from baseline to month 6, and month 12. | 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 | |
Secondary | Changes in daily average steps of parents over the 12 month study duration. | Daily average steps will be calculated based on data captured by the Fitbit wireless pedometer. | Daily from months 1 - 12 | |
Secondary | Changes in daily average steps of children over the 12 month study duration. | Daily average steps will be calculated based on data captured by the Fitbit wireless pedometer. | Daily from months 1 - 12 | |
Secondary | Changes in percentage of parents meeting weekly step targets over the 12 month study duration. | Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer. | Daily from months 1 - 12 | |
Secondary | Changes in percentage of children meeting weekly step targets over the 12 month study duration. | Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer. | Daily from months 1 - 12 | |
Secondary | Changes in percentage of parent-child dyads meeting weekly step targets over the 12 month study duration. | Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer. | Daily from months 1 - 12 | |
Secondary | Change in weight of parents from baseline to month 6, and month 12. | 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 | |
Secondary | Change in systolic blood pressure of parents from baseline to month 6 and month 12. | 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 | |
Secondary | Change in cardiorespiratory fitness of parents from baseline to month 6, and month 12. | 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 | |
Secondary | Change in health-related quality of life of parents from baseline to month 6, and month 12. | 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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