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Exploring the Effect of an Intervention on Women's Physical Activity Behaviour

23. März 2020 aktualisiert von: Jennifer Brunet, University of Ottawa

Exploring the Effect of an eHealth Intervention on Women's Physical Activity Behaviour

Physical activity has been shown to reduce the risk of chronic diseases and promote physical and mental health and wellbeing, yet few women are active enough to see these benefits. Wearable activity trackers show promise for helping people increase their physical activity levels by supporting self-monitoring. However, few researchers have examined how providing people with these devices impacts physical activity levels, or motivation for physical activity which is a significant and robust predictor of physical activity. Based on previous research, it is possible that women's physical activity levels would be more likely to increase if they received an autonomy-supportive intervention to enhance motivation in addition to a wearable activity tracker. A pilot, three-armed randomized controlled trial was developed to test this hypothesis and to assess if changes in perceived autonomy-support, basic psychological need satisfaction/thwarting, motivational regulations, wellbeing indicators are associated with changes in physical activity over time.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

49

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

  • Kanada
    • Ontario
      • Ottawa, Ontario, Kanada, K1N6N5
        • University of Ottawa

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

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

All participants will need to meet the following inclusion criteria to participate in the intervention:

  1. Are a woman between the ages of 18 and 65 years
  2. Can understand, read, and speak in English
  3. Are able to safely engage in physical activity
  4. Are not currently pregnant or lactating
  5. Currently participating in less than 150 minutes of moderate or vigorous intensity physical activity and less than two strength training sessions per week
  6. Are overweight or obese (i.e., have a body mass index greater than 25kg/m2)
  7. Have access to the Internet and an email account
  8. Have not used a wearable activity tracker within the past year (e.g., Fitbit, Apple Watch, Garmin, Polar)
  9. Live within 50km of the University of Ottawa

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: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Group 1
Participants in the main experimental group will receive a copy of the Canadian Physical Activity Guidelines that provide basic information about and recommendations for physical activity, a wearable activity tracker to support self-monitoring, and autonomy-support delivered through weekly emails to help enhance motivation for physical activity.
Verhalten: Physical Activity Information
Participants will receive a copy of the Canadian Physical Activity Guidelines.
Verhalten: Physical Activity Monitoring
Participants will receive a wearable activity tracker (Polar A300).
Verhalten: Autonomy-support
Participants will receive eight autonomy-supportive weekly emails containing information and activities to help them set goals and make changes to become physically active.
Aktiver Komparator: Group 2
Participants in this comparison group will receive a copy of the Canadian Physical Activity Guidelines that provide basic information about and recommendations for physical activity, and a wearable activity tracker to support self-monitoring. They will not receive any specific support to enhance motivation for physical activity.
Verhalten: Physical Activity Information
Participants will receive a copy of the Canadian Physical Activity Guidelines.
Verhalten: Physical Activity Monitoring
Participants will receive a wearable activity tracker (Polar A300).
Aktiver Komparator: Group 3
Participants in this information-only comparison group will receive a copy of the Canadian Physical Activity Guidelines that provide basic information about and recommendations for physical activity.
Verhalten: Physical Activity Information
Participants will receive a copy of the Canadian Physical Activity Guidelines.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S)
Zeitfenster: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention, and from post-intervention to follow-up.
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Physical activity behaviour: Custom strength and resistance training questionnaire
Zeitfenster: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Change in strength and resistance training habits from baseline to post-intervention, and from post-intervention to follow-up.
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Physical activity behaviour: Direct measure
Zeitfenster: Duration of intervention phase (8 weeks).
Change in weekly directly measured levels of physical activity as measured by accelerometers (Polar A300), which will be worn by participants assigned to Group 1 and Group 2 during waking hours for the duration of the intervention.
Duration of intervention phase (8 weeks).
Perceived autonomy support: Perceived Autonomy Support Scale for Exercise Settings (PASSES; Hagger et al., 2007)
Zeitfenster: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Change in perceived autonomy support for physical activity from baseline to post-intervention, and from post-intervention to follow-up.
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Basic psychological need satisfaction: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)
Zeitfenster: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Change in basic psychological need satisfaction for physical activity from baseline to post-intervention, and from post-intervention to follow-up.
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Motivational regulations: Behavioral Regulation in Exercise Questionnaire (BREQ-2R; Markland & Tobin, 2004; Wilson, Rodgers, Loitz, & Scime, 2006)
Zeitfenster: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Change in motivational regulations for physical activity from baseline to post-intervention, and from post-intervention to follow-up.
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Basic psychological need thwarting: Psychological Need Thwarting Scale (PNTS; Bartholomew, Ntoumanis, Ryan, & Thøgersen-Ntoumani, 2011)
Zeitfenster: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Change in basic psychological need thwarting activity from baseline to post-intervention, and from post-intervention to follow-up.
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Positive and Negative Affect Schedule (I-PANAS-SF; Thompson, 2016; Watson, Clark, & Tellegen, 1988).
Zeitfenster: : Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Change in affect from baseline to post-intervention, and from post-intervention to follow-up.
: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Vitality: Subjective Vitality Scale (Ryan & Frederick, 1997).
Zeitfenster: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Change in vitality affect from baseline to post-intervention, and from post-intervention to follow-up.
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Depression: Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001).
Zeitfenster: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Change in depressive symptoms from baseline to post-intervention, and from post-intervention to follow-up.
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Wearable activity tracker usage: Multiple choice questions
Zeitfenster: Post-intervention (week 9).
Frequency of wearable activity tracker usage in general during the intervention phase for participants randomized to Group 1 or Group 2.
Post-intervention (week 9).
Recruitment rates
Zeitfenster: Duration of recruitment and intervention phases (9 weeks).
The number of eligible participants who enrol in the study out of the number assessed for eligibility.
Duration of recruitment and intervention phases (9 weeks).
Retention rates
Zeitfenster: Duration of recruitment and intervention phases (9 weeks).
The number of participants completing all scheduled assessments.
Duration of recruitment and intervention phases (9 weeks).
Acceptability: Open ended questions
Zeitfenster: Duration of recruitment and intervention phases (9 weeks).
For participants randomized to Group 1, what participants liked, disliked, and would change about the intervention.
Duration of recruitment and intervention phases (9 weeks).
Body mass
Zeitfenster: Baseline (week 0) and post-intervention (week 9).
Change in body mass measured from baseline to post-intervention as determined using a scale (Tanita BWB 800S).
Baseline (week 0) and post-intervention (week 9).
Body composition
Zeitfenster: Baseline (week 0) and post-intervention (week 9).
Change in body composition from baseline to post-intervention as determined by a scale (Tanita BWB 800S) that uses bioelectrical impedance to assess body composition.
Baseline (week 0) and post-intervention (week 9).
Waist circumference
Zeitfenster: Baseline (week 0) and post-intervention (week 9).
Change in waist circumference from baseline to post-intervention as measured using a measuring tape.
Baseline (week 0) and post-intervention (week 9).

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sociodemographic questionnaire
Zeitfenster: Baseline (week 0).
Sociodemographic and health information will be collected at baseline to describe the sample. Measures include age, marital status, race, level of education, employment status, household income, number and age of children, self-rated health, medical conditions, menstrual status, smoking history, and weight-related goals.
Baseline (week 0).

Mitarbeiter und Ermittler

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

Sponsor

University of Ottawa

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.

Allgemeine Veröffentlichungen

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. September 2018

Primärer Abschluss (Tatsächlich)

22. April 2019

Studienabschluss (Tatsächlich)

30. August 2019

Studienanmeldedaten

Zuerst eingereicht

4. Juli 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Juli 2018

Zuerst gepostet (Tatsächlich)

26. Juli 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. März 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. März 2020

Zuletzt verifiziert

1. März 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • eHealth_Women_PA

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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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