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Completed

NCT Number: NCT03601663

Exploring the Effect of an 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.

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Key information

Conditions

Physical Activity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity information

Behavioral

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

Physical activity monitoring

Behavioral

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

Autonomy-support

Behavioral

Participants will receive eight autonomy-supportive weekly emails containing information and activities to help them set goals and make changes to become physically active.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Physical activity behaviour: Direct measure

    Time frame: 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.

  2. 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).

    Change in perceived autonomy support for physical activity from baseline to post-intervention, and from post-intervention to follow-up.

  3. 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).

    Change in basic psychological need satisfaction for physical activity from baseline to post-intervention, and from post-intervention to follow-up.

  4. 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).

    Change in motivational regulations for physical activity from baseline to post-intervention, and from post-intervention to follow-up.

  5. 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).

    Change in basic psychological need thwarting activity from baseline to post-intervention, and from post-intervention to follow-up.

  6. 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).

    Change in affect from baseline to post-intervention, and from post-intervention to follow-up.

  7. Vitality: Subjective Vitality Scale (Ryan & Frederick, 1997).

    Time frame: 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.

  8. Depression: Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001).

    Time frame: 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.

  9. Wearable activity tracker usage: Multiple choice questions

    Time frame: 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.

  10. Recruitment rates

    Time frame: 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.

  11. Retention rates

    Time frame: Duration of recruitment and intervention phases (9 weeks).

    The number of participants completing all scheduled assessments.

  12. Acceptability: Open ended questions

    Time frame: Duration of recruitment and intervention phases (9 weeks).

    For participants randomized to Group 1, what participants liked, disliked, and would change about the intervention.

  13. Body mass

    Time frame: 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).

  14. Body composition

    Time frame: 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.

  15. Waist circumference

    Time frame: Baseline (week 0) and post-intervention (week 9).

    Change in waist circumference from baseline to post-intervention as measured using a measuring tape.

Other outcomes

  1. Sociodemographic questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Ottawa

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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