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

23 marzo 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

49

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: Physical Activity Information
Participants will receive a copy of the Canadian Physical Activity Guidelines.
Comportamentale: Physical Activity Monitoring
Participants will receive a wearable activity tracker (Polar A300).
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: Physical Activity Information
Participants will receive a copy of the Canadian Physical Activity Guidelines.
Comportamentale: Physical Activity Monitoring
Participants will receive a wearable activity tracker (Polar A300).
Comparatore attivo: 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.
Comportamentale: Physical Activity Information
Participants will receive a copy of the Canadian Physical Activity Guidelines.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S)
Lasso di tempo: 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
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Physical activity behaviour: Direct measure
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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).
Lasso di tempo: : 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).
Lasso di tempo: 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).
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Sociodemographic questionnaire
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Ottawa

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 settembre 2018

Completamento primario (Effettivo)

22 aprile 2019

Completamento dello studio (Effettivo)

30 agosto 2019

Date di iscrizione allo studio

Primo inviato

4 luglio 2018

Primo inviato che soddisfa i criteri di controllo qualità

17 luglio 2018

Primo Inserito (Effettivo)

26 luglio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 marzo 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 marzo 2020

Ultimo verificato

1 marzo 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • eHealth_Women_PA

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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