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- Klinische proef NCT02659163
An Integrated Closed-loop Feedback System for Pediatric Cardiometabolic Disease (STRIVE)
31 augustus 2017 bijgewerkt door: Nicolas M. Oreskovic, MD, MPH, Massachusetts General Hospital
The high prevalence and burden of cardiometabolic disease underlie the urgent need to identify novel approaches to managing and preventing cardiometabolic disease and risk.
This project will test an innovative use of mobile health technology to implement a closed-loop feedback system that collects objective patient-generated data and provides clinical recommendations to modify contributing health behaviors.
In addition to improving care for cardiometabolic disease, the tools and methods developed by this study for collecting patient data and providing clinical feedback could also easily be adapted and applied to a range of other health conditions, and are thus highly relevant to public health.
Studie Overzicht
Toestand
Onbekend
Conditie
Gedetailleerde beschrijving
Cardiometabolic disease - a clustering of medical conditions and risk factors which includes obesity, diabetes, impaired liver function, and an increased risk in children for adult-onset cardiovascular disease - represents a major population-wide health burden in the United States.
Management of cardiometabolic disease also imposes a substantial financial burden on the economy and ties up significant healthcare resources.
It is well-known that many of the lifestyle and health behaviors that contribute to cardiometabolic disease are difficult to modify once established, and childhood represents an opportune time for promoting healthy behaviors.
Patient-centered outcomes research (PCOR) has identified certain health behaviors as important and actionable in modifying cardiometabolic risk, namely weight management, physical activity, screen-time, sleep, and consumption of sugar-sweetened beverages.
Mobile health technology (mHealth) could be used to monitor and counsel on common health behaviors associated with cardiometabolic risk, which may facilitate the inclusion of PCOR evidence on cardiometabolic disease into clinical practice.
The overall goal of this research is to use mHealth technology to accelerate the uptake of PCOR findings on treatment of cardiometabolic disease.
To achieve our goal, this study will develop a novel set of mHealth tools capable of collecting health behavior information and determine to what extent providing clinical feedback on these health behaviors improves obesity and health behaviors among children ages 6-12 year and their families.
In this study we will develop, implement, and test the comparative clinical effectiveness of a closed-loop feedback system for collecting patient data and providing recommendations.
The specific aims of this study are: 1) to develop an integrated closed-loop feedback system that incorporates longitudinal mHealth data in managing cardiometabolic disease among at-risk families, and 2) to determine the extent to which an integrated closed-loop system that provides feedback on objective patient-generated data improves cardiometabolic risk, as measured by changes in body mass index and health behaviors including, physical activity, screen-time, sleep, and sugar-sweetened beverage consumption.
This research will develop novel mHealth tools and approaches that will allow healthcare providers and patients to better understand disease risk and improve disease management by collecting patient data 1) repeatedly over time, 2) simultaneously, and 3) objectively.
This study is innovative because it will use mHealth tools to simultaneously collect longitudinal data on multiple health behaviors known to be associated with cardiometabolic risk, and it will offer a new approach to implementing and disseminating PCOR findings via a novel closed-loop feedback system.
The high prevalence of cardiometabolic disease makes this innovative closed-loop system very relevant to public health.
The mHealth tools and methods developed by this study for collecting patient data and providing clinical feedback could also easily be adapted and applied to a range of other health conditions.
Studietype
Ingrijpend
Inschrijving (Verwacht)
68
Fase
- Vroege fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
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
6 jaar tot 12 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- ages 6-12 years
- body mass index categorized as overweight or obese
- followed for obesity care
- an adult household family member with one or more elevated cardiometabolic risk, as defined by established or documented increased risk of cardiometabolic disease (overweight, obesity, hypertension, coronary artery disease, diabetes or glucose intolerance, dyslipidemia, non-alcoholic fatty liver disease, cerebrovascular disease)
- participating parent must own Android Smartphone
- Wi-Fi access at home
- speak and read English
Exclusion Criteria:
- n/a
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: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: intervention
Intervention subjects will receive feedback on their health behaviors along with clinical recommendations.
|
A wristband containing several sensors worn by participants to collect daily objective patient-generated health behavior data on physical activity, sleep, and screen time
Andere namen:
A wireless scale used by participants to measure and record daily weight.
Andere namen:
Self-reported information on sugar sweetened beverage consumption collected via mobile messaging
Andere namen:
A mobile application that houses study data and provides two-way messaging between the study team and study participants.
Daily feedback and weekly e-report cards on patient-generated longitudinal health behaviors along with clinical recommendations via mobile messaging
|
Actieve vergelijker: control
Control subjects will receive feedback on their health behaviors for self-guided care.
|
A wristband containing several sensors worn by participants to collect daily objective patient-generated health behavior data on physical activity, sleep, and screen time
Andere namen:
A wireless scale used by participants to measure and record daily weight.
Andere namen:
Self-reported information on sugar sweetened beverage consumption collected via mobile messaging
Andere namen:
A mobile application that houses study data and provides two-way messaging between the study team and study participants.
Provide feedback on patient-generated health behaviors data, along with standard of care recommendations, for self-guided
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
BMI, Child
Tijdsspanne: 6 months
|
mean change in BMI z-score
|
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Health Behaviors Index, Child and Adult
Tijdsspanne: 6 months
|
Cardiometabolic risk will be reported as an index score, a continuous variable calculated as the sum of Z-scores of mean daily moderate-to-vigorous physical activity (minutes), mean daily sleep (minutes), mean daily screen time (minutes), and mean weekly sugar sweetened beverage intake.
|
6 months
|
BMI, Adult
Tijdsspanne: 6 months
|
mean change in BMI z-score
|
6 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Nicolas M Oreskovic, MD, MPH, Massachusetts General Hospital
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
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 (Verwacht)
1 oktober 2017
Primaire voltooiing (Verwacht)
1 oktober 2018
Studie voltooiing (Verwacht)
1 oktober 2018
Studieregistratiedata
Eerst ingediend
12 januari 2016
Eerst ingediend dat voldeed aan de QC-criteria
14 januari 2016
Eerst geplaatst (Schatting)
20 januari 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
1 september 2017
Laatste update ingediend die voldeed aan QC-criteria
31 augustus 2017
Laatst geverifieerd
1 augustus 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R21HS024001 (Amerikaanse AHRQ-subsidie/contract)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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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