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PAthway To Health (PATH): Fostering Culturally Appropriate Physical Activities in Indigenous Communities (PATH)

27. Juni 2017 aktualisiert von: Linda Li, University of British Columbia

PAthway To Health (PATH): Fostering Culturally Appropriate Physical Activities Using Digital Technology in Indigenous Communities

Being physically active is important for everyone's health, but it is often challenging for people to start and sustain an activity routine. The investigators will develop and pilot test the PATH (PAthway To Health) program with Indigenous communities served by the Kwakiutl District Council (KDC) Health on North Vancouver Island. The project idea was conceived through a partnership between the communities and University of British Columbia health researchers. The PATH program will include an education sessions on how to be active, physical activity coaching by community health workers, and the use of Fitbit Flex (a wearable activity tracker). The investigators will develop a culturally appropriate online application to pair with Fitbit, which will provide instant feedback to individuals about their activity level. 60 community members will be recruited to test the PATH program. Their physical activity level, health status and use of activity resources at KDC Health Centres will be assessed.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

Background: Promoting an active lifestyle is a priority identified by the communities served by KDC Health. Statistics Canada estimates obesity in one in four adults based on 2007-2009 data, with higher prevalence among Indigenous people compared to non-Aboriginal population (between 26% and 36% among adults living off-reserve and on-reserve, respectively). Furthermore, Indigenous people also report higher prevalence of obesity associated complications, including diabetes, cardiovascular disease, and arthritis. The association between physical inactivity and obesity suggests that increasing physical activity is important.

KDC Health offers a variety of free programs to community members, however, the use of these services has been low. KDC Health has previously partnered with the CIHR-funded IMPAKT project, and has expressed a strong interest in developing an intervention to improve health and wellness in the communities.

Objectives:

  1. To determine whether the PATH program can improve physical activity participation in the communities served by KDC Health.
  2. To assess the effect of this program on reducing sedentary time, and increasing the use of health promotion and wellness services offered by KDC Health
  3. To assess the correlation of physical activity levels and the secondary outcome measures among individuals who are living in the same household.

Methods: The investigators will conduct a community-based proof-of-concept randomized controlled trial (RCT) with 60 eligible participants. Only 1 member per household will be enrolled. If more than 1 member is interested, they will select 1 person by consensus or by a random draw.

After obtaining the baseline measures, participants will be randomly assigned to the 'Now Group' (target=30) or 'Later Group' (target=30).

The Now Group will participate in a brief education session held at the KDC Health Centre, use a wearable physical activity tracker (Fitbit Flex), and physical activity mentoring by a KDC Health Staff (the Activity Mentors). The Activity Mentors have received training for the project from the Principal Investigator. In Month 1-2, participants will meet with their Activity Mentor once every 2 weeks to review their physical activity status, activity goals, and the health programs available at the Centre. In Month 3-4, they will continue to use Fitbit Flex but will no longer have regular meetings with the Activity Mentor.

The Later Group will receive intervention two months later (i.e., Month 3-4).

The primary outcome measure will be the time spent in moderate/vigorous physical activity. In addition, time spent in sedentary behaviours will be recorded. Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, 2 months, and 4 months. Secondary outcome measures include sedentary time measured with SenseWear Mini, health status that will be measured using the SF-36 (a generic measure of health-related quality of life), and body weight. Participants' use of KDC Health programs and their motivation to be physically active will also be recorded.

At the end of the program, participants will be interviewed for 30 minutes in person about their opinion on the intervention. Interviews will focus on 1) barriers/facilitators to being physically active, 2) their experience with the intervention, and 3) the nature of activities they engage in.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

60

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

    • British Columbia
      • Richmond, British Columbia, Kanada, V6X 2C7
        • Arthritis Research Canada

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

19 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria: Participants are eligible if they:

  1. Are a person from KDC Health Member Nations
  2. Are 19 years or older
  3. Have no health condition that prevents them from being physically active
  4. Are able to participate in a 4-month project -

Exclusion Criteria: Participants are not eligible to participate if they:

  1. Do not meet the criteria above
  2. Use medication that may impair activity tolerance (e.g., beta blockers),
  3. Are unable to provide informed consent -

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Now Group - PATH Program
The Now Group will receive the PATH program. They will participate in a brief education session, use a wearable physical activity tracker, and physical activity mentoring by an Activity Mentors. In Month 1 and 2, participants will meet with their Activity Mentor once every 2 weeks to review their physical activity status, activity goals, and the health programs available at the Centre. In Month 3 and 4, they will continue to use physical activity tracker but will no longer have regular meetings with the Activity Mentor.
A brief education session, use of a wearable physical activity tracker, and physical activity mentoring by an Activity Mentor every 2 weeks.
Aktiver Komparator: Later Group
The Later Group will receive the PATH program in Month 1-2. Intervention will be provided two months later (i.e., Month 3 and 4).
A brief education session, use of a wearable physical activity tracker, and physical activity mentoring by an Activity Mentor every 2 weeks.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time spent in Moderate to Vigorous Physical Activity (MVPA), measured by SenseWear Mini accelerometer
Zeitfenster: Change from baseline in Time spent in MVPA at 2 months and 4 months
Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, and Months 2 and 4.
Change from baseline in Time spent in MVPA at 2 months and 4 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time spent in sedentary behaviours, measured by SenseWear Mini accelerometer
Zeitfenster: Change from baseline in time spent in sedentary behaviours at 2 months and 4 months
Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, and Months 2 and 4.
Change from baseline in time spent in sedentary behaviours at 2 months and 4 months
Change in Health Status, measured by SF-36 Questionnaire
Zeitfenster: Change from baseline health status at 2 months and 4 months
SF-36 Questionnaire
Change from baseline health status at 2 months and 4 months
Change in Body weight, measured by measured with a calibrated scale
Zeitfenster: Change from baseline body weight at 2 months and 4 months
Measured with a calibrated scale
Change from baseline body weight at 2 months and 4 months

Mitarbeiter und Ermittler

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

Ermittler

  • Hauptermittler: Linda Li, PT, PhD, Arthritis Research Canada

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 (Tatsächlich)

1. Februar 2015

Primärer Abschluss (Tatsächlich)

1. Mai 2016

Studienabschluss (Tatsächlich)

1. Juni 2016

Studienanmeldedaten

Zuerst eingereicht

5. Januar 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Januar 2015

Zuerst gepostet (Schätzen)

13. Januar 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Juni 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Juni 2017

Zuletzt verifiziert

1. Juni 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • H12-02526

Plan für individuelle Teilnehmerdaten (IPD)

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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