- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02659163
An Integrated Closed-loop Feedback System for Pediatric Cardiometabolic Disease (STRIVE)
31. August 2017 aktualisiert von: 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.
Studienübersicht
Status
Unbekannt
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
68
Phase
- Frühphase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
6 Jahre bis 12 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
|
|
Aktiver Komparator: 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
BMI, Child
Zeitfenster: 6 months
|
mean change in BMI z-score
|
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Health Behaviors Index, Child and Adult
Zeitfenster: 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
Zeitfenster: 6 months
|
mean change in BMI z-score
|
6 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Nicolas M Oreskovic, MD, MPH, Massachusetts General Hospital
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Voraussichtlich)
1. Oktober 2017
Primärer Abschluss (Voraussichtlich)
1. Oktober 2018
Studienabschluss (Voraussichtlich)
1. Oktober 2018
Studienanmeldedaten
Zuerst eingereicht
12. Januar 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. Januar 2016
Zuerst gepostet (Schätzen)
20. Januar 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. September 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
31. August 2017
Zuletzt verifiziert
1. August 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R21HS024001 (US-AHRQ-Zuschuss/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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