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A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

5. Mai 2015 aktualisiert von: St. Jude Children's Research Hospital

A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

Five year survival following a diagnosis of childhood cancer has reached 83%, making long term health outcomes among survivors an important concern. The growing population of survivors is at an increased risk of physical inactivity and associated adverse health outcomes. Regular physical activity is associated with better cardiovascular and musculoskeletal health. Despite the known benefits of physical activity, nearly half of all childhood cancer survivors do not meet recommended guidelines for physical activity.

Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a rewards-based physical activity intervention delivered via an interactive website among young adolescent childhood cancer survivors, aged 11 through 14 years, will increase physical activity levels and improve cardiovascular and musculoskeletal health. The investigators also want to learn if this rewards-based intervention is effective. To achieve this goal the investigators have designed a three-arm prospective, randomized study with two reward-based intervention groups and a control group.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

PRIMARY OBJECTIVE:

  • To compare changes in levels of moderate and vigorous physical activity over 24 weeks.

SECONDARY OBJECTIVE:

  • To compare changes in cardiorespiratory fitness, muscular strength and flexibility over 24 weeks.

Participants will be randomized to one of three groups. Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. Participants randomized to the two intervention groups will be given access to a rewards program delivered via an interactive website, an activity monitor, and educational materials. Individual physical activity data can be viewed by study participants after uploading information from their monitors to the interactive website. One intervention group will receive minimal rewards, while the other group will receive immediate incentives as well as the minimal rewards as they move from one level to the other on the website.

After 24 weeks, changes in cardiorespiratory fitness, muscular strength, flexibility, and physical function will be compared between the two intervention groups and the control group.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

105

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Tennessee
      • Memphis, Tennessee, Vereinigte Staaten, 38105
        • St. Jude Children's Research Hospital

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

11 Jahre bis 14 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Previously treated for childhood cancer at St. Jude Children's Research Hospital (SJCRH)
  • 11 through 14 years of age
  • Not undergoing active treatment for cancer
  • Medical clearance from participant's attending physician via email
  • Does not meet the Centers for Disease Control (CDC) physical activity guidelines. CDC guidelines for children age 11 to 14 are defined as 60 minutes or more per day of physical activity, seven days a week
  • Internet access and a computer that has software that is compatible with the study device (Windows XP, Windows Vista, Windows 7, Mac OSX 10.5 and Mac OSX 10.6)

Exclusion Criteria:

  • Global cognitive impairment (Full Scale Intelligence Quotient < 70) that prevents use of the interactive website
  • Pregnant female
  • Inability to read and write English

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Group A: Minimal Rewards
Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Verhalten: Activity Monitor
Measurement of physical activity.
Andere Namen:
  • Tri-Axial Accelerometer
  • Zamzee
Verhalten: Interactive Website
Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Andere Namen:
  • Zamzee Website
Verhalten: Educational Materials
All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Andere Namen:
  • Informationsbroschüre
Experimental: Group B: Immediate Incentives

Participants use an activity monitor and the interactive website.

In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Verhalten: Activity Monitor
Measurement of physical activity.
Andere Namen:
  • Tri-Axial Accelerometer
  • Zamzee
Verhalten: Interactive Website
Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
Andere Namen:
  • Zamzee Website
Verhalten: Educational Materials
All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Andere Namen:
  • Informationsbroschüre
Experimental: Group C: Control
Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Verhalten: Activity Monitor
Measurement of physical activity.
Andere Namen:
  • Tri-Axial Accelerometer
  • Zamzee
Verhalten: Educational Materials
All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Andere Namen:
  • Informationsbroschüre

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups
Zeitfenster: Baseline, Week 24
The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.
Baseline, Week 24

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks
Zeitfenster: Baseline and 24 weeks
The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.
Baseline and 24 weeks
Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach
Zeitfenster: Baseline and 24 weeks
The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups
Baseline and 24 weeks
Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion
Zeitfenster: Baseline and 24 weeks
The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip
Zeitfenster: Baseline and 24 weeks
The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up
Zeitfenster: Baseline and 24 weeks
The number of sit-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup
Zeitfenster: Baseline and 24 weeks
The number of push-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second
Zeitfenster: Baseline and 24 weeks
The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second
Zeitfenster: Baseline and 24 weeks
The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second
Zeitfenster: Baseline and 24 weeks
The difference from baseline to 24-weeks in mean changes in knee extension strength at 180 degrees per second (Newton meters) was compared between groups
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second
Zeitfenster: Baseline and 24 weeks
The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups.
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second
Zeitfenster: Baseline and 24 weeks
The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength at 60 degrees per second (Newton meters) was compared between groups.
Baseline and 24 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

St. Jude Children's Research Hospital

Ermittler

  • Hauptermittler: Kirsten K. Ness, PT, PhD, St. Jude Children's Research 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

1. Februar 2013

Primärer Abschluss (Tatsächlich)

1. April 2014

Studienabschluss (Tatsächlich)

1. April 2014

Studienanmeldedaten

Zuerst eingereicht

18. Januar 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Januar 2013

Zuerst gepostet (Schätzen)

29. Januar 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

21. Mai 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Mai 2015

Zuletzt verifiziert

1. April 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • ZAMZEE
  • NCI-2013-00384 (Registrierungskennung: NCI Clinical Trial Registration Program)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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