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

6 juli 2018 bijgewerkt door: Eric A. Finkelstein, Duke-NUS Graduate Medical School
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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

644

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Singapore
      • Singapore, Singapore, 169857
        • Duke-NUS Medical School

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

7 jaar tot 65 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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
Apparaat: Fitbit
Fitbit-apparaten zijn draadloze stappentellers die de stappen van deelnemers volgen en worden aangeboden in combinatie met een op maat gemaakte website met op maat gemaakte informatie voor deelnemers.
Andere namen:
  • Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity tracker
Gedragsmatig: Incentives
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
Andere namen:
  • Rewards, gift vouchers
Experimenteel: 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
Apparaat: Fitbit
Fitbit-apparaten zijn draadloze stappentellers die de stappen van deelnemers volgen en worden aangeboden in combinatie met een op maat gemaakte website met op maat gemaakte informatie voor deelnemers.
Andere namen:
  • Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity tracker
Gedragsmatig: Incentives
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
Andere namen:
  • Rewards, gift vouchers

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in step count of parents from baseline to month 6, and month 12.
Tijdsspanne: 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.
Baseline, 6 months and 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in step count of children from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in moderate to vigorous physical activity (MVPA) bout minutes of parents from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in moderate to vigorous physical activity (MVPA) bout minutes of children from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in moderate to vigorous physical activity (MVPA) minutes of parents from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in moderate to vigorous physical activity (MVPA) minutes of children from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in total volume of physical activity of parents from baseline to month 6 and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in total volume of physical activity of children from baseline to month 6 and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in sedentary behaviour of parents from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in sedentary behaviour of children from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in light minutes of parents from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in light minutes of children from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in total moderate minutes of parents from baseline to month 6 and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in total moderate minutes of children from baseline to month 6 and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in total vigorous minutes of parents from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in total vigorous minutes of children from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Changes in daily average steps of parents over the 12 month study duration.
Tijdsspanne: Daily from months 1 - 12
Daily average steps will be calculated based on data captured by the Fitbit wireless pedometer.
Daily from months 1 - 12
Changes in daily average steps of children over the 12 month study duration.
Tijdsspanne: Daily from months 1 - 12
Daily average steps will be calculated based on data captured by the Fitbit wireless pedometer.
Daily from months 1 - 12
Changes in percentage of parents meeting weekly step targets over the 12 month study duration.
Tijdsspanne: Daily from months 1 - 12
Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
Daily from months 1 - 12
Changes in percentage of children meeting weekly step targets over the 12 month study duration.
Tijdsspanne: Daily from months 1 - 12
Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
Daily from months 1 - 12
Changes in percentage of parent-child dyads meeting weekly step targets over the 12 month study duration.
Tijdsspanne: Daily from months 1 - 12
Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
Daily from months 1 - 12
Change in weight of parents from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Change in systolic blood pressure of parents from baseline to month 6 and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Change in cardiorespiratory fitness of parents from baseline to month 6, and month 12.
Tijdsspanne: Baseline, 6 months and 12 months
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
Change in health-related quality of life of parents from baseline to month 6, and month 12.
Tijdsspanne: Baseline, months and 12 months
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Duke-NUS Graduate Medical School

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

25 november 2015

Primaire voltooiing (Werkelijk)

28 mei 2018

Studie voltooiing (Werkelijk)

3 juni 2018

Studieregistratiedata

Eerst ingediend

27 april 2015

Eerst ingediend dat voldeed aan de QC-criteria

3 augustus 2015

Eerst geplaatst (Schatting)

5 augustus 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 juli 2018

Laatste update ingediend die voldeed aan QC-criteria

6 juli 2018

Laatst geverifieerd

1 juli 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • HSRG13may010

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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