Physical ActivityFIT-FAMNCT02516345
Randomized Controlled Trial of an Incentive-based Physical Activity Program Targeting Both Children and Adults (FIT-FAM)
A study testing Fitbit and Incentives in people with Physical Activity, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 7 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Fitbit and Incentives
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 644 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Nov 2015to 3 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Fitbit, Incentives
- Keywords
- Physical activity, Financial incentives, Children, Parents, RCT, Wireless pedometer
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitDevice
Also called Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity tracker
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.
IncentivesBehavioural
Also called Rewards, gift vouchers
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Fitbit; Behavioral: 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 Receives: Device: Fitbit; Behavioral: Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months and 12 months
Secondary outcomes (24)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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).
Measured: 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.
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).
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Daily from months 1 - 12
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.
Measured: Daily from months 1 - 12
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.
Measured: Daily from months 1 - 12
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.
Measured: Daily from months 1 - 12
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.
Measured: Daily from months 1 - 12
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, 6 months and 12 months
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.
Measured: Baseline, months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study start25 Nov 2015
- Primary completion28 May 2018
- Study completion3 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 644 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric A. Finkelstein, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516345
- Sponsor's protocol ID
- HSRG13may010
- Acronym
- FIT-FAM
- Status last verified
- Jul 2018
- First submitted
- 27 Apr 2015
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32912260
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of an Incentive-based Physical Activity Program Targeting Both Children and Adults (FIT-FAM)
- ClinicalTrials.gov ID
- NCT02516345
- Acronym / sponsor ID
- FIT-FAM / HSRG13may010
- Conditions
- Physical Activity
- Keywords
- Physical activity, Financial incentives, Children, Parents, RCT, Wireless pedometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 644 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Study start
- 25 Nov 2015 (actual)
- Primary completion
- 28 May 2018 (actual)
- Study completion
- 3 Jun 2018 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child-based Incentive (CBI) | Active comparator | Device: Fitbit, Behavioral: IncentivesChildren 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 |
| Family-based Incentive (FBI) | Experimental | Device: Fitbit, Behavioral: IncentivesChildren 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 |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitbitAlso: Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity trackerFitbit 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. | Device | Child-based Incentive (CBI), Family-based Incentive (FBI) |
| IncentivesAlso: Rewards, gift vouchersIncentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer. | Behavioural | Child-based Incentive (CBI), Family-based Incentive (FBI) |
Primary outcome
Changes in step count of parents from baseline to month 6, and month 12.
Time frame: Baseline, 6 months and 12 months
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.
24 secondary outcomes
Changes in step count of children from baseline to month 6, and month 12.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months and 12 months
Changes in total volume of physical activity of parents from baseline to month 6 and month 12.
Time frame: Baseline, 6 months and 12 months
Changes in total volume of physical activity of children from baseline to month 6 and month 12.
Time frame: Baseline, 6 months and 12 months
Changes in sedentary behaviour of parents from baseline to month 6, and month 12.
Time frame: Baseline, 6 months and 12 months
Changes in sedentary behaviour of children from baseline to month 6, and month 12.
Time frame: Baseline, 6 months and 12 months
Changes in light minutes of parents from baseline to month 6, and month 12.
Time frame: Baseline, 6 months and 12 months
Changes in light minutes of children from baseline to month 6, and month 12.
Time frame: Baseline, 6 months and 12 months
Changes in total moderate minutes of parents from baseline to month 6 and month 12.
Time frame: Baseline, 6 months and 12 months
Changes in total moderate minutes of children from baseline to month 6 and month 12.
Time frame: Baseline, 6 months and 12 months
Changes in total vigorous minutes of parents from baseline to month 6, and month 12.
Time frame: Baseline, 6 months and 12 months
Changes in total vigorous minutes of children from baseline to month 6, and month 12.
Time frame: Baseline, 6 months and 12 months
Changes in daily average steps of parents over the 12 month study duration.
Time frame: Daily from months 1 - 12
Changes in daily average steps of children over the 12 month study duration.
Time frame: Daily from months 1 - 12
Changes in percentage of parents meeting weekly step targets over the 12 month study duration.
Time frame: Daily from months 1 - 12
Changes in percentage of children meeting weekly step targets over the 12 month study duration.
Time frame: Daily from months 1 - 12
Changes in percentage of parent-child dyads meeting weekly step targets over the 12 month study duration.
Time frame: Daily from months 1 - 12
Change in weight of parents from baseline to month 6, and month 12.
Time frame: Baseline, 6 months and 12 months
Change in systolic blood pressure of parents from baseline to month 6 and month 12.
Time frame: Baseline, 6 months and 12 months
Change in cardiorespiratory fitness of parents from baseline to month 6, and month 12.
Time frame: Baseline, 6 months and 12 months
Change in health-related quality of life of parents from baseline to month 6, and month 12.
Time frame: Baseline, months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Derived from this study: PubMed 32912260Finkelstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit and Incentives in people with Physical Activity, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in step count of parents from baseline to month 6, and month 12. (time frame: Baseline, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02516345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.