NCT02516345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
644

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 25, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2018

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2018

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

2.5 years

First QC Date

April 27, 2015

Last Update Submit

July 6, 2018

Conditions

Keywords

Physical activityFinancial incentivesChildrenParentsRCTWireless pedometer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (24)

  • Changes in step count of children from baseline to month 6, and month 12.

    Baseline, 6 months and 12 months

  • Changes in moderate to vigorous physical activity (MVPA) bout minutes of parents from baseline to month 6, and month 12.

    Baseline, 6 months and 12 months

  • Changes in moderate to vigorous physical activity (MVPA) bout minutes of children from baseline to month 6, and month 12.

    Baseline, 6 months and 12 months

  • Changes in moderate to vigorous physical activity (MVPA) minutes of parents from baseline to month 6, and month 12.

    Baseline, 6 months and 12 months

  • Changes in moderate to vigorous physical activity (MVPA) minutes of children from baseline to month 6, and month 12.

    Baseline, 6 months and 12 months

  • +19 more secondary outcomes

Study Arms (2)

Child-based Incentive (CBI)

ACTIVE COMPARATOR

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

Device: FitbitBehavioral: Incentives

Family-based Incentive (FBI)

EXPERIMENTAL

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

Device: FitbitBehavioral: Incentives

Interventions

FitbitDEVICE

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.

Also known as: Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity tracker
Child-based Incentive (CBI)Family-based Incentive (FBI)
IncentivesBEHAVIORAL

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

Also known as: Rewards, gift vouchers
Child-based Incentive (CBI)Family-based Incentive (FBI)

Eligibility Criteria

Age7 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke-NUS Medical School

Singapore, 169857, Singapore

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Fertility

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2015

First Posted

August 5, 2015

Study Start

November 25, 2015

Primary Completion

May 28, 2018

Study Completion

June 3, 2018

Last Updated

July 10, 2018

Record last verified: 2018-07

Locations