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

23. marts 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

49

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1N6N5
        • University of Ottawa

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Physical Activity Information
Participants will receive a copy of the Canadian Physical Activity Guidelines.
Adfærdsmæssigt: Physical Activity Monitoring
Participants will receive a wearable activity tracker (Polar A300).
Adfærdsmæssigt: 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.
Aktiv 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.
Adfærdsmæssigt: Physical Activity Information
Participants will receive a copy of the Canadian Physical Activity Guidelines.
Adfærdsmæssigt: Physical Activity Monitoring
Participants will receive a wearable activity tracker (Polar A300).
Aktiv 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.
Adfærdsmæssigt: Physical Activity Information
Participants will receive a copy of the Canadian Physical Activity Guidelines.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S)
Tidsramme: 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
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical activity behaviour: Direct measure
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
Tidsramme: : 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).
Tidsramme: 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).
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sociodemographic questionnaire
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Ottawa

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2018

Primær færdiggørelse (Faktiske)

22. april 2019

Studieafslutning (Faktiske)

30. august 2019

Datoer for studieregistrering

Først indsendt

4. juli 2018

Først indsendt, der opfyldte QC-kriterier

17. juli 2018

Først opslået (Faktiske)

26. juli 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • eHealth_Women_PA

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fysisk aktivitet

Kliniske forsøg med Physical Activity Information

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Poland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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