Randomized Controlled Trial of an Incentive-based Physical Activity Program Targeting Both Children and Adults (FIT-FAM) (FIT-FAM)
6 juillet 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
644
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Singapore, Singapour, 169857
- Duke-NUS Medical School
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
7 ans à 65 ans (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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:
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Les appareils Fitbit sont des podomètres sans fil qui suivent les pas des participants et seront proposés en conjonction avec un site Web sur mesure contenant des informations personnalisées pour les participants.
Autres noms:
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
Autres noms:
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Expérimental: 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:
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Les appareils Fitbit sont des podomètres sans fil qui suivent les pas des participants et seront proposés en conjonction avec un site Web sur mesure contenant des informations personnalisées pour les participants.
Autres noms:
Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in step count of parents from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in step count of children from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in moderate to vigorous physical activity (MVPA) bout minutes of parents from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in moderate to vigorous physical activity (MVPA) bout minutes of children from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in moderate to vigorous physical activity (MVPA) minutes of parents from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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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).
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Baseline, 6 months and 12 months
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Changes in moderate to vigorous physical activity (MVPA) minutes of children from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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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).
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Baseline, 6 months and 12 months
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Changes in total volume of physical activity of parents from baseline to month 6 and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in total volume of physical activity of children from baseline to month 6 and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in sedentary behaviour of parents from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in sedentary behaviour of children from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in light minutes of parents from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in light minutes of children from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in total moderate minutes of parents from baseline to month 6 and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in total moderate minutes of children from baseline to month 6 and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in total vigorous minutes of parents from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in total vigorous minutes of children from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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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.
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Baseline, 6 months and 12 months
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Changes in daily average steps of parents over the 12 month study duration.
Délai: Daily from months 1 - 12
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Daily average steps will be calculated based on data captured by the Fitbit wireless pedometer.
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Daily from months 1 - 12
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Changes in daily average steps of children over the 12 month study duration.
Délai: Daily from months 1 - 12
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Daily average steps will be calculated based on data captured by the Fitbit wireless pedometer.
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Daily from months 1 - 12
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Changes in percentage of parents meeting weekly step targets over the 12 month study duration.
Délai: Daily from months 1 - 12
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Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
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Daily from months 1 - 12
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Changes in percentage of children meeting weekly step targets over the 12 month study duration.
Délai: Daily from months 1 - 12
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Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
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Daily from months 1 - 12
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Changes in percentage of parent-child dyads meeting weekly step targets over the 12 month study duration.
Délai: Daily from months 1 - 12
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Percentage meeting weekly step targets will be calculated based on data captured by the Fitbit wireless pedometer.
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Daily from months 1 - 12
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Change in weight of parents from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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Weight of parents will be measured at baseline, month 6, and month 12, and the difference will be calculated.
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Baseline, 6 months and 12 months
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Change in systolic blood pressure of parents from baseline to month 6 and month 12.
Délai: Baseline, 6 months and 12 months
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Systolic blood pressure of parents will be measured at baseline, month 6, and month 12, and the difference will be calculated.
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Baseline, 6 months and 12 months
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Change in cardiorespiratory fitness of parents from baseline to month 6, and month 12.
Délai: Baseline, 6 months and 12 months
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VO2max of parents will be measured at baseline, month 6, and month 12, and the difference will be calculated.
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Baseline, 6 months and 12 months
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Change in health-related quality of life of parents from baseline to month 6, and month 12.
Délai: Baseline, months and 12 months
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Health-related quality of life of parents at baseline, month 6, and month 12 will be measured via the EQ-5D-5L questionnaire.
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Baseline, months and 12 months
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Collaborateurs et enquêteurs
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Publications et liens utiles
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
25 novembre 2015
Achèvement primaire (Réel)
28 mai 2018
Achèvement de l'étude (Réel)
3 juin 2018
Dates d'inscription aux études
Première soumission
27 avril 2015
Première soumission répondant aux critères de contrôle qualité
3 août 2015
Première publication (Estimation)
5 août 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 juillet 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juillet 2018
Dernière vérification
1 juillet 2018
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HSRG13may010
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .