Exploring the Effect of an Intervention on Women's Physical Activity Behaviour
2020年3月23日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
49
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Ontario
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Ottawa、Ontario、カナダ、K1N6N5
- University of Ottawa
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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Participants will receive a copy of the Canadian Physical Activity Guidelines.
Participants will receive a wearable activity tracker (Polar A300).
Participants will receive eight autonomy-supportive weekly emails containing information and activities to help them set goals and make changes to become physically active.
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アクティブコンパレータ：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.
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Participants will receive a copy of the Canadian Physical Activity Guidelines.
Participants will receive a wearable activity tracker (Polar A300).
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アクティブコンパレータ：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.
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Participants will receive a copy of the Canadian Physical Activity Guidelines.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S)
時間枠：Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention, and from post-intervention to follow-up.
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Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Physical activity behaviour: Custom strength and resistance training questionnaire
時間枠：Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Change in strength and resistance training habits from baseline to post-intervention, and from post-intervention to follow-up.
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Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical activity behaviour: Direct measure
時間枠：Duration of intervention phase (8 weeks).
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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.
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Duration of intervention phase (8 weeks).
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Perceived autonomy support: Perceived Autonomy Support Scale for Exercise Settings (PASSES; Hagger et al., 2007)
時間枠：Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Change in perceived autonomy support for physical activity from baseline to post-intervention, and from post-intervention to follow-up.
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Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Basic psychological need satisfaction: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)
時間枠：Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Change in basic psychological need satisfaction for physical activity from baseline to post-intervention, and from post-intervention to follow-up.
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Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Motivational regulations: Behavioral Regulation in Exercise Questionnaire (BREQ-2R; Markland & Tobin, 2004; Wilson, Rodgers, Loitz, & Scime, 2006)
時間枠：Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Change in motivational regulations for physical activity from baseline to post-intervention, and from post-intervention to follow-up.
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Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Basic psychological need thwarting: Psychological Need Thwarting Scale (PNTS; Bartholomew, Ntoumanis, Ryan, & Thøgersen-Ntoumani, 2011)
時間枠：Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Change in basic psychological need thwarting activity from baseline to post-intervention, and from post-intervention to follow-up.
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Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Positive and Negative Affect Schedule (I-PANAS-SF; Thompson, 2016; Watson, Clark, & Tellegen, 1988).
時間枠：: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Change in affect from baseline to post-intervention, and from post-intervention to follow-up.
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: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Vitality: Subjective Vitality Scale (Ryan & Frederick, 1997).
時間枠：Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Change in vitality affect from baseline to post-intervention, and from post-intervention to follow-up.
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Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Depression: Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001).
時間枠：Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Change in depressive symptoms from baseline to post-intervention, and from post-intervention to follow-up.
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Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
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Wearable activity tracker usage: Multiple choice questions
時間枠：Post-intervention (week 9).
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Frequency of wearable activity tracker usage in general during the intervention phase for participants randomized to Group 1 or Group 2.
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Post-intervention (week 9).
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Recruitment rates
時間枠：Duration of recruitment and intervention phases (9 weeks).
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The number of eligible participants who enrol in the study out of the number assessed for eligibility.
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Duration of recruitment and intervention phases (9 weeks).
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Retention rates
時間枠：Duration of recruitment and intervention phases (9 weeks).
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The number of participants completing all scheduled assessments.
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Duration of recruitment and intervention phases (9 weeks).
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Acceptability: Open ended questions
時間枠：Duration of recruitment and intervention phases (9 weeks).
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For participants randomized to Group 1, what participants liked, disliked, and would change about the intervention.
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Duration of recruitment and intervention phases (9 weeks).
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Body mass
時間枠：Baseline (week 0) and post-intervention (week 9).
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Change in body mass measured from baseline to post-intervention as determined using a scale (Tanita BWB 800S).
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Baseline (week 0) and post-intervention (week 9).
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Body composition
時間枠：Baseline (week 0) and post-intervention (week 9).
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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.
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Baseline (week 0) and post-intervention (week 9).
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Waist circumference
時間枠：Baseline (week 0) and post-intervention (week 9).
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Change in waist circumference from baseline to post-intervention as measured using a measuring tape.
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Baseline (week 0) and post-intervention (week 9).
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sociodemographic questionnaire
時間枠：Baseline (week 0).
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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.
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Baseline (week 0).
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
- 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.
- Hagger, 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
- Markland, 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.
- Thompson, 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
- Wilson, 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.
- Black 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年9月1日
一次修了 (実際)
2019年4月22日
研究の完了 (実際)
2019年8月30日
試験登録日
最初に提出
2018年7月4日
QC基準を満たした最初の提出物
2018年7月17日
最初の投稿 (実際)
2018年7月26日
学習記録の更新
投稿された最後の更新 (実際)
2020年3月24日
QC基準を満たした最後の更新が送信されました
2020年3月23日
最終確認日
2020年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。