Physical ActivityNCT03601663
Exploring the Effect of an Intervention on Women's Physical Activity Behaviour
A study testing Physical Activity Information, Physical Activity Monitoring and Autonomy-support in people with Physical Activity, run by University of Ottawa at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Physical Activity Information, Physical Activity Monitoring and Autonomy-support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
All participants will need to meet the following inclusion criteria to participate in the intervention:
- Are a woman between the ages of 18 and 65 years
- Can understand, read, and speak in English
- Are able to safely engage in physical activity
- Are not currently pregnant or lactating
- Currently participating in less than 150 minutes of moderate or vigorous intensity physical activity and less than two strength training sessions per week
- Are overweight or obese (i.e., have a body mass index greater than 25kg/m2)
- Have access to the Internet and an email account
- Have not used a wearable activity tracker within the past year (e.g., Fitbit, Apple Watch, Garmin, Polar)
- Live within 50km of the University of Ottawa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Physical Activity
- Being tested
- Physical Activity Information, Physical Activity Monitoring, Autonomy-support
- Keywords
- physical activity, obesity, pilot study, randomized controlled trial, women, eHealth
- Medical subject headings
- Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity InformationBehavioural
Participants will receive a copy of the Canadian Physical Activity Guidelines.
Physical Activity MonitoringBehavioural
Participants will receive a wearable activity tracker (Polar A300).
Autonomy-supportBehavioural
Participants will receive eight autonomy-supportive weekly emails containing information and activities to help them set goals and make changes to become physically active.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Behavioral: Physical Activity Information; Behavioral: Physical Activity Monitoring; Behavioral: Autonomy-support |
| Group 2 | Active comparator | 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. Receives: Behavioral: Physical Activity Information; Behavioral: Physical Activity Monitoring |
| Group 3 | Active comparator | 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. Receives: Behavioral: Physical Activity Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S)
Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention, and from post-intervention to follow-up.
Measured: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Physical activity behaviour: Custom strength and resistance training questionnaire
Change in strength and resistance training habits from baseline to post-intervention, and from post-intervention to follow-up.
Measured: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Secondary outcomes (15)
Physical activity behaviour: Direct measure
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.
Measured: Duration of intervention phase (8 weeks).
Perceived autonomy support: Perceived Autonomy Support Scale for Exercise Settings (PASSES; Hagger et al., 2007)
Change in perceived autonomy support for physical activity from baseline to post-intervention, and from post-intervention to follow-up.
Measured: 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)
Change in basic psychological need satisfaction for physical activity from baseline to post-intervention, and from post-intervention to follow-up.
Measured: 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)
Change in motivational regulations for physical activity from baseline to post-intervention, and from post-intervention to follow-up.
Measured: 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)
Change in basic psychological need thwarting activity from baseline to post-intervention, and from post-intervention to follow-up.
Measured: 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).
Change in affect from baseline to post-intervention, and from post-intervention to follow-up.
Measured: : Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Vitality: Subjective Vitality Scale (Ryan & Frederick, 1997).
Change in vitality affect from baseline to post-intervention, and from post-intervention to follow-up.
Measured: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Depression: Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001).
Change in depressive symptoms from baseline to post-intervention, and from post-intervention to follow-up.
Measured: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Wearable activity tracker usage: Multiple choice questions
Frequency of wearable activity tracker usage in general during the intervention phase for participants randomized to Group 1 or Group 2.
Measured: Post-intervention (week 9).
Recruitment rates
The number of eligible participants who enrol in the study out of the number assessed for eligibility.
Measured: Duration of recruitment and intervention phases (9 weeks).
Retention rates
The number of participants completing all scheduled assessments.
Measured: Duration of recruitment and intervention phases (9 weeks).
Acceptability: Open ended questions
For participants randomized to Group 1, what participants liked, disliked, and would change about the intervention.
Measured: Duration of recruitment and intervention phases (9 weeks).
Body mass
Change in body mass measured from baseline to post-intervention as determined using a scale (Tanita BWB 800S).
Measured: Baseline (week 0) and post-intervention (week 9).
Body composition
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.
Measured: Baseline (week 0) and post-intervention (week 9).
Waist circumference
Change in waist circumference from baseline to post-intervention as measured using a measuring tape.
Measured: Baseline (week 0) and post-intervention (week 9).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Sep 2018
- Primary completion22 Apr 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Brunet, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601663
- Sponsor's protocol ID
- eHealth_Women_PA
- Status last verified
- Mar 2020
- First submitted
- 4 Jul 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bartholomew KJ, Ntoumanis N, Ryan RM, Thogersen-Ntoumani C. Psychological need thwarting in the sport context: assessing the darker side of athletic experience. J Sport Exerc Psychol. 2011 Feb;33(1):75-102. doi: 10.1123/jsep.33.1.75.
PubMed 21451172Hagger, M. S., Chatzisarantis, N. L., Hein, V., Pihu, M., Soós, I., & Karsai, I. (2007). The perceived autonomy support scale for exercise settings (PASSES): Development, validity, and cross-cultural invariance in young people. Psychology of Sport and Exercise, 8(5), 632-653. doi:10.1016/j.psychsport.2006.09.001
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Markland, D., & Tobin, V. (2004). A modification to the behavioural regulation in exercise questionnaire to include an assessment of amotivation. Journal of Sport & Exercise Psychology, 26, 191-196.
Ryan RM, Frederick C. On energy, personality, and health: subjective vitality as a dynamic reflection of well-being. J Pers. 1997 Sep;65(3):529-65. doi: 10.1111/j.1467-6494.1997.tb00326.x.
PubMed 9327588Thompson, E. R. (2016). Development and validation of an internationally reliable short-form of the Positive and Negative Affect Schedule (PANAS). Journal of Cross-Cultural Psychology, 38(2), 227-242. doi:10.1177/0022022106297301
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Wilson, P. M., Rodgers, W. M., Loitz, C., & Scime, G. (2006). "It's who I am… really!" The importance of integrated regulation in exercise contexts. Journal of Applied Biobehavioural Research, 11(2), 79-104.
Wilson, P. M., Rogers, T., Rodgers, W. M., & Wild, C. (2006). The psychological need satisfaction in exercise scale. Journal of Sport & Exercise Psychology, 28, 231-251.
Brunet J, Sharma S, Price J, Black M. Acceptability and Usability of a Theory-Driven Intervention via Email to Promote Physical Activity in Women Who Are Overweight or Obese: Substudy Within a Randomized Controlled Trial. JMIR Form Res. 2023 Oct 3;7:e48301. doi: 10.2196/48301.
PubMed 37788048Black M, Brunet J. A Wearable Activity Tracker Intervention With and Without Weekly Behavioral Support Emails to Promote Physical Activity Among Women Who Are Overweight or Obese: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 16;9(12):e28128. doi: 10.2196/28128.
PubMed 34927590
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of an eHealth Intervention on Women's Physical Activity Behaviour
- ClinicalTrials.gov ID
- NCT03601663
- Acronym / sponsor ID
- eHealth_Women_PA
- Conditions
- Physical Activity
- Keywords
- physical activity, obesity, pilot study, randomized controlled trial, women, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Physical Activity Information, Behavioral: Physical Activity Monitoring, Behavioral: Autonomy-supportParticipants 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. |
| Group 2 | Active comparator | Behavioral: Physical Activity Information, Behavioral: Physical Activity MonitoringParticipants 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. |
| Group 3 | Active comparator | Behavioral: Physical Activity InformationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity InformationParticipants will receive a copy of the Canadian Physical Activity Guidelines. | Behavioural | Group 1, Group 2, Group 3 |
| Physical Activity MonitoringParticipants will receive a wearable activity tracker (Polar A300). | Behavioural | Group 1, Group 2 |
| Autonomy-supportParticipants will receive eight autonomy-supportive weekly emails containing information and activities to help them set goals and make changes to become physically active. | Behavioural | Group 1 |
Primary outcome
Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S)
Time frame: 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.
Physical activity behaviour: Custom strength and resistance training questionnaire
Time frame: 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.
15 secondary outcomes
Physical activity behaviour: Direct measure
Time frame: Duration of intervention phase (8 weeks).
Perceived autonomy support: Perceived Autonomy Support Scale for Exercise Settings (PASSES; Hagger et al., 2007)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: : Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Vitality: Subjective Vitality Scale (Ryan & Frederick, 1997).
Time frame: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Depression: Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001).
Time frame: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Wearable activity tracker usage: Multiple choice questions
Time frame: Post-intervention (week 9).
Recruitment rates
Time frame: Duration of recruitment and intervention phases (9 weeks).
Retention rates
Time frame: Duration of recruitment and intervention phases (9 weeks).
Acceptability: Open ended questions
Time frame: Duration of recruitment and intervention phases (9 weeks).
Body mass
Time frame: Baseline (week 0) and post-intervention (week 9).
Body composition
Time frame: Baseline (week 0) and post-intervention (week 9).
Waist circumference
Time frame: Baseline (week 0) and post-intervention (week 9).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 21451172Bartholomew KJ, Ntoumanis N, Ryan RM, Thogersen-Ntoumani C. Psychological need thwarting in the sport context: assessing the darker side of athletic experience. J Sport Exerc Psychol. 2011 Feb;33(1):75-102. doi: 10.1123/jsep.33.1.75.
- BackgroundHagger, M. S., Chatzisarantis, N. L., Hein, V., Pihu, M., Soós, I., & Karsai, I. (2007). The perceived autonomy support scale for exercise settings (PASSES): Development, validity, and cross-cultural invariance in young people. Psychology of Sport and Exercise, 8(5), 632-653. doi:10.1016/j.psychsport.2006.09.001
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- BackgroundMarkland, D., & Tobin, V. (2004). A modification to the behavioural regulation in exercise questionnaire to include an assessment of amotivation. Journal of Sport & Exercise Psychology, 26, 191-196.
- Background: PubMed 9327588Ryan RM, Frederick C. On energy, personality, and health: subjective vitality as a dynamic reflection of well-being. J Pers. 1997 Sep;65(3):529-65. doi: 10.1111/j.1467-6494.1997.tb00326.x.
- BackgroundThompson, E. R. (2016). Development and validation of an internationally reliable short-form of the Positive and Negative Affect Schedule (PANAS). Journal of Cross-Cultural Psychology, 38(2), 227-242. doi:10.1177/0022022106297301
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- BackgroundWilson, P. M., Rodgers, W. M., Loitz, C., & Scime, G. (2006). "It's who I am… really!" The importance of integrated regulation in exercise contexts. Journal of Applied Biobehavioural Research, 11(2), 79-104.
- BackgroundWilson, P. M., Rogers, T., Rodgers, W. M., & Wild, C. (2006). The psychological need satisfaction in exercise scale. Journal of Sport & Exercise Psychology, 28, 231-251.
- Derived from this study: PubMed 37788048Brunet J, Sharma S, Price J, Black M. Acceptability and Usability of a Theory-Driven Intervention via Email to Promote Physical Activity in Women Who Are Overweight or Obese: Substudy Within a Randomized Controlled Trial. JMIR Form Res. 2023 Oct 3;7:e48301. doi: 10.2196/48301.
- Derived from this study: PubMed 34927590Black M, Brunet J. A Wearable Activity Tracker Intervention With and Without Weekly Behavioral Support Emails to Promote Physical Activity Among Women Who Are Overweight or Obese: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 16;9(12):e28128. doi: 10.2196/28128.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Information, Physical Activity Monitoring and Autonomy-support in people with Physical Activity, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S) (time frame: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03601663, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.