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

Physical Activity Clinical Trial

— FIT-FAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516345
• Other study ID #: HSRG13may010
• Status: Completed
• Phase: N/A
• Start date: November 25, 2015
• Est. completion date: June 3, 2018

Study information

• Verified date: July 2018
• Source: Duke-NUS Graduate Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.

Behavioral:
• Incentives
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.

Locations

Country	Name	City	State
Singapore	Duke-NUS Medical School	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School

Country where clinical trial is conducted

Singapore, 

Outcome

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