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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03601663
Enrollment
49
Registered
2018-07-26
Start date
2018-09-01
Completion date
2019-08-30
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

physical activity, obesity, pilot study, randomized controlled trial, women, eHealth

Brief summary

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.

Interventions

Participants will receive a copy of the Canadian Physical Activity Guidelines.

Participants will receive a wearable activity tracker (Polar A300).

BEHAVIORALAutonomy-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.

Sponsors

University of Ottawa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Physical activity behaviour: Custom strength and resistance training questionnaireBaseline (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.
Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S)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.

Secondary

MeasureTime frameDescription
Perceived autonomy support: Perceived Autonomy Support Scale for Exercise Settings (PASSES; Hagger et al., 2007)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.
Basic psychological need satisfaction: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)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.
Motivational regulations: Behavioral Regulation in Exercise Questionnaire (BREQ-2R; Markland & Tobin, 2004; Wilson, Rodgers, Loitz, & Scime, 2006)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.
Basic psychological need thwarting: Psychological Need Thwarting Scale (PNTS; Bartholomew, Ntoumanis, Ryan, & Thøgersen-Ntoumani, 2011)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.
Positive and Negative Affect Schedule (I-PANAS-SF; Thompson, 2016; Watson, Clark, & Tellegen, 1988).: 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.
Vitality: Subjective Vitality Scale (Ryan & Frederick, 1997).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.
Depression: Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001).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.
Recruitment ratesDuration of recruitment and intervention phases (9 weeks).The number of eligible participants who enrol in the study out of the number assessed for eligibility.
Retention ratesDuration of recruitment and intervention phases (9 weeks).The number of participants completing all scheduled assessments.
Acceptability: Open ended questionsDuration of recruitment and intervention phases (9 weeks).For participants randomized to Group 1, what participants liked, disliked, and would change about the intervention.
Body massBaseline (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).
Body compositionBaseline (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.
Waist circumferenceBaseline (week 0) and post-intervention (week 9).Change in waist circumference from baseline to post-intervention as measured using a measuring tape.
Wearable activity tracker usage: Multiple choice questionsPost-intervention (week 9).Frequency of wearable activity tracker usage in general during the intervention phase for participants randomized to Group 1 or Group 2.
Physical activity behaviour: Direct measureDuration 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.

Other

MeasureTime frameDescription
Sociodemographic questionnaireBaseline (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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026