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

6 luglio 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

644

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 7 anni a 65 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Dispositivo: Fitbit
I dispositivi Fitbit sono contapassi wireless che tengono traccia dei passi dei partecipanti e saranno offerti insieme a un sito Web su misura con informazioni personalizzate per i partecipanti.
Altri nomi:
  • Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity tracker
Comportamentale: Incentives
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
Altri nomi:
  • Rewards, gift vouchers
Sperimentale: 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
Dispositivo: Fitbit
I dispositivi Fitbit sono contapassi wireless che tengono traccia dei passi dei partecipanti e saranno offerti insieme a un sito Web su misura con informazioni personalizzate per i partecipanti.
Altri nomi:
  • Fitbit Zip, Fitbit Flex, wireless pedometer, physical activity tracker
Comportamentale: Incentives
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
Altri nomi:
  • Rewards, gift vouchers

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in step count of parents from baseline to month 6, and month 12.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in step count of children from baseline to month 6, and month 12.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Duke-NUS Graduate Medical School

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 novembre 2015

Completamento primario (Effettivo)

28 maggio 2018

Completamento dello studio (Effettivo)

3 giugno 2018

Date di iscrizione allo studio

Primo inviato

27 aprile 2015

Primo inviato che soddisfa i criteri di controllo qualità

3 agosto 2015

Primo Inserito (Stima)

5 agosto 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 luglio 2018

Ultimo verificato

1 luglio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • HSRG13may010

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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