Clinical trial NCT02516345: Randomized Controlled Trial of an Incentive-based Physical Activity Program Targeting Both Children and Adults (FIT-FAM)
Official title: Randomized Controlled Trial of an Incentive-based Physical Activity Program Targeting Both Children and Adults (FIT-FAM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Physical activity
Financial incentives
Children
Parents
RCT
Wireless pedometer
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
First posted: 2015-08-05
Enrollment: 644
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in step count of parents from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: Changes in step count of children from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in moderate to vigorous physical activity (MVPA) bout minutes of parents from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in moderate to vigorous physical activity (MVPA) bout minutes of children from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in moderate to vigorous physical activity (MVPA) minutes of parents from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in moderate to vigorous physical activity (MVPA) minutes of children from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in total volume of physical activity of parents from baseline to month 6 and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in total volume of physical activity of children from baseline to month 6 and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in sedentary behaviour of parents from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in sedentary behaviour of children from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in light minutes of parents from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in light minutes of children from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in total moderate minutes of parents from baseline to month 6 and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in total moderate minutes of children from baseline to month 6 and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in total vigorous minutes of parents from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in total vigorous minutes of children from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Changes in daily average steps of parents over the 12 month study duration.
timeFrame: Daily from months 1 - 12
measure: Changes in daily average steps of children over the 12 month study duration.
timeFrame: Daily from months 1 - 12
measure: Changes in percentage of parents meeting weekly step targets over the 12 month study duration.
timeFrame: Daily from months 1 - 12
measure: Changes in percentage of children meeting weekly step targets over the 12 month study duration.
timeFrame: Daily from months 1 - 12
measure: Changes in percentage of parent-child dyads meeting weekly step targets over the 12 month study duration.
timeFrame: Daily from months 1 - 12
measure: Change in weight of parents from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Change in systolic blood pressure of parents from baseline to month 6 and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Change in cardiorespiratory fitness of parents from baseline to month 6, and month 12.
timeFrame: Baseline, 6 months and 12 months
measure: Change in health-related quality of life of parents from baseline to month 6, and month 12.
timeFrame: Baseline, months and 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Duke-NUS Medical School
Study officials:
References:
citation: 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.