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

NCT ID: NCT02516345

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 644 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-25
• Study Completion Date: 2018-06-03

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.

Conditions

Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Fitbit

Intervention Type: DEVICE

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.

Incentives

Intervention Type: BEHAVIORAL

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

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

Group Type: EXPERIMENTAL

Fitbit

Intervention Type: DEVICE

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.

Incentives

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: DEVICE

Incentives

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity tracker; Rewards, gift vouchers

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke-NUS Graduate Medical School

OTHER

Sponsor Role: lead

Responsible Party

Eric A. Finkelstein

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Duke-NUS Medical School

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: DERIVED

PMID: 32912260 (View on PubMed)

Other Identifiers

HSRG13may010

Identifier Type: -

Identifier Source: org_study_id