| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Activity Adequacy Mindsets | Behavioral: Accurate step count feedback Behavioral: Deflated step count feedback Behavioral: Inflated step count feedback Behavioral: Accurate feedback + mindset intervention | Not Applicable |
Study Overview: This study examines how individuals' mindsets about the adequacy of their level of physical activity and its corresponding health consequences (activity adequacy mindsets) affect health outcomes. Participants attend an "onboarding" lab session in which they complete physiological, cognitive, and psychological measures and receive an Apple Watch to wear for the following 5 weeks. The Watch is equipped with a step count tracking app. No step count feedback is provided in week 1 as a baseline; starting in week 2, participants are randomized to 4 conditions in which either 1) accurate, 2) inflated, or 3) deflated step count is displayed on the watch in order to manipulate participants' perceived physical activity, independently of their actual physical activity. In condition 4, participants receive a meta-mindset intervention in addition to accurate step count feedback. Throughout the 5 weeks, participants complete short daily surveys and longer weekly surveys administered online. Finally, participants come in for an "offboarding" lab session in which the same measures are collected as in the onboarding session.
Participants: Participants will be 160 healthy adults recruited from the community, 40 per condition.
Main Hypotheses: This is a largely exploratory study, examining various mechanisms through which activity adequacy mindsets may affect health and wellbeing. Tests include (but are not limited to) the following key hypotheses:
H1) Inflated step count feedback (compared to accurate feedback) leads to a more positive activity adequacy mindset, and deflated feedback (compared to accurate feedback) leads to a more negative activity adequacy mindset (see Primary Outcome Measures).
H2) Activity adequacy mindset influences health and wellbeing (see Primary Outcome Measures) over and above actual physical activity.
H3) Activity adequacy mindset influences health and wellbeing through various mechanisms (see Secondary Outcome Measures):
H3a) Affective mechanism: A more positive (vs. negative) activity adequacy mindset leads to more positive everyday affect (incl. higher satisfaction, lower anxiety, lower stress). Positive affect in turn improves health and wellbeing.
H3b) Motivational/ behavioral mechanism: A more positive (vs. negative) activity adequacy mindset leads to higher motivation to exercise and improve one's health, as well as higher exercise self-efficacy. Higher motivation and self-efficacy in turn lead to higher levels of actual physical activity, which in turn improve health and wellbeing.
H3c) Placebo mechanism: A more positive (vs. negative) activity adequacy mindset directly improves health and wellbeing through placebo/ nocebo effects.
H4) A meta-mindset intervention teaching people about activity adequacy mindsets leads them to adopt more positive mindsets, which in turn predicts improved health and wellbeing through the mechanisms described under H3. That is, compared to accurate step count feedback only, accurate feedback plus meta-mindset intervention leads to improved health and wellbeing.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 164 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Basic Science |
| Official Title: | Harnessing Mindset in 21st Century Healthcare: Leveraging Mindset in Health Technology |
| Actual Study Start Date : | May 30, 2018 |
| Actual Primary Completion Date : | November 15, 2019 |
| Actual Study Completion Date : | November 15, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Accurate step count feedback
All arms are given identical instructions in the onboarding session, including information about the study purpose and Apple Watch. They complete the same set of physiological, cognitive, and psychological measures and receive an Apple Watch to wear for the following 5 weeks. Throughout the 5 weeks, participants complete short daily surveys and longer weekly surveys. Finally, participants come in for an "offboarding" lab session in which the same measures are collected as in the onboarding session. In this arm, participants' Apple Watches will simply display their accurate step count. |
Behavioral: Accurate step count feedback
After one week of baseline step count measurement, participants will receive the intervention. Starting day 8, participants' Apple Watches will start displaying their step count. In this arm, they will simply see their accurate step count.
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Experimental: Deflated step count feedback
All arms are given identical instructions in the onboarding session, including information about the study purpose and Apple Watch. They complete the same set of physiological, cognitive, and psychological measures and receive an Apple Watch to wear for the following 5 weeks. Throughout the 5 weeks, participants complete short daily surveys and longer weekly surveys. Finally, participants come in for an "offboarding" lab session in which the same measures are collected as in the onboarding session. In this arm, participants' Apple Watches will display a deflated step count. |
Behavioral: Deflated step count feedback
After one week of baseline step count measurement, participants will receive the intervention. Starting day 8, participants' Apple Watches will start displaying their step count. In this arm, they will see their step count deflated by 40% (i.e., their step count multiplied by 0.6).
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Experimental: Inflated step count feedback
All arms are given identical instructions in the onboarding session, including information about the study purpose and Apple Watch. They complete the same set of physiological, cognitive, and psychological measures and receive an Apple Watch to wear for the following 5 weeks. Throughout the 5 weeks, participants complete short daily surveys and longer weekly surveys. Finally, participants come in for an "offboarding" lab session in which the same measures are collected as in the onboarding session. In this arm, participants' Apple Watches will display an inflated step count. |
Behavioral: Inflated step count feedback
After one week of baseline step count measurement, participants will receive the intervention. Starting day 8, participants' Apple Watches will start displaying their step count. In this arm, they will see their step count inflated by 40% (i.e., their step count multiplied by 1.4).
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Experimental: Accurate feedback + mindset intervention
All arms are given identical instructions in the onboarding session, including information about the study purpose and Apple Watch. They complete the same set of physiological, cognitive, and psychological measures and receive an Apple Watch to wear for the following 5 weeks. Throughout the 5 weeks, participants complete short daily surveys and longer weekly surveys. Finally, participants come in for an "offboarding" lab session in which the same measures are collected as in the onboarding session. In this arm, participants' Apple Watches will display their accurate step count. Additionally, participants in this arm will receive a meta-mindset intervention. |
Behavioral: Accurate feedback + mindset intervention
After one week of baseline step count measurement, participants will receive the intervention. Starting day 8, participants' Apple Watches will start displaying their step count. In this arm, they will simply see their accurate step count. Additionally, participants in this arm will receive a meta-mindset intervention in the first weekly survey on day 7, which consists of a series of videos and reflection exercises to teach participants about the power of mindsets and encourage them to choose adaptive mindsets that will benefit their health. There are also short booster reflection exercises in all subsequent daily and weekly surveys, reinforcing the message about adaptive mindsets. |
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Alia J Crum, PhD | Stanford University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 11, 2019 | ||||
| First Posted Date ICMJE | May 7, 2019 | ||||
| Last Update Posted Date | January 30, 2020 | ||||
| Actual Study Start Date ICMJE | May 30, 2018 | ||||
| Actual Primary Completion Date | November 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Physical Activity Adequacy Mindsets on Health and Wellbeing | ||||
| Official Title ICMJE | Harnessing Mindset in 21st Century Healthcare: Leveraging Mindset in Health Technology | ||||
| Brief Summary | It is widely known that physical activity is important for health and wellbeing, yet most Americans do not meet recommended levels of activity. People may commonly believe that only the actual amount of physical activity matters for health and wellbeing. However, the investigators propose that individuals' mindsets about the adequacy of their level of physical activity and its corresponding health consequences (activity adequacy mindsets) affect health outcomes, over and above their actual level of physical activity. In recent years, health technologies such as wearable fitness trackers have become popular tools to promote higher levels of physical activity. This study leverages the tracking and feedback capabilities of Apple Watch to study the effects of mindsets about physical activity on health and wellbeing, as well as the pathways through which these effects may occur. | ||||
| Detailed Description |
Study Overview: This study examines how individuals' mindsets about the adequacy of their level of physical activity and its corresponding health consequences (activity adequacy mindsets) affect health outcomes. Participants attend an "onboarding" lab session in which they complete physiological, cognitive, and psychological measures and receive an Apple Watch to wear for the following 5 weeks. The Watch is equipped with a step count tracking app. No step count feedback is provided in week 1 as a baseline; starting in week 2, participants are randomized to 4 conditions in which either 1) accurate, 2) inflated, or 3) deflated step count is displayed on the watch in order to manipulate participants' perceived physical activity, independently of their actual physical activity. In condition 4, participants receive a meta-mindset intervention in addition to accurate step count feedback. Throughout the 5 weeks, participants complete short daily surveys and longer weekly surveys administered online. Finally, participants come in for an "offboarding" lab session in which the same measures are collected as in the onboarding session. Participants: Participants will be 160 healthy adults recruited from the community, 40 per condition. Main Hypotheses: This is a largely exploratory study, examining various mechanisms through which activity adequacy mindsets may affect health and wellbeing. Tests include (but are not limited to) the following key hypotheses: H1) Inflated step count feedback (compared to accurate feedback) leads to a more positive activity adequacy mindset, and deflated feedback (compared to accurate feedback) leads to a more negative activity adequacy mindset (see Primary Outcome Measures). H2) Activity adequacy mindset influences health and wellbeing (see Primary Outcome Measures) over and above actual physical activity. H3) Activity adequacy mindset influences health and wellbeing through various mechanisms (see Secondary Outcome Measures): H3a) Affective mechanism: A more positive (vs. negative) activity adequacy mindset leads to more positive everyday affect (incl. higher satisfaction, lower anxiety, lower stress). Positive affect in turn improves health and wellbeing. H3b) Motivational/ behavioral mechanism: A more positive (vs. negative) activity adequacy mindset leads to higher motivation to exercise and improve one's health, as well as higher exercise self-efficacy. Higher motivation and self-efficacy in turn lead to higher levels of actual physical activity, which in turn improve health and wellbeing. H3c) Placebo mechanism: A more positive (vs. negative) activity adequacy mindset directly improves health and wellbeing through placebo/ nocebo effects. H4) A meta-mindset intervention teaching people about activity adequacy mindsets leads them to adopt more positive mindsets, which in turn predicts improved health and wellbeing through the mechanisms described under H3. That is, compared to accurate step count feedback only, accurate feedback plus meta-mindset intervention leads to improved health and wellbeing. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Activity Adequacy Mindsets | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
164 | ||||
| Original Estimated Enrollment ICMJE |
160 | ||||
| Actual Study Completion Date ICMJE | November 15, 2019 | ||||
| Actual Primary Completion Date | November 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03939572 | ||||
| Other Study ID Numbers ICMJE | 36098 DP2AT009511 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Alia Crum, Stanford University | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | National Center for Complementary and Integrative Health (NCCIH) | ||||
| Investigators ICMJE |
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| PRS Account | Stanford University | ||||
| Verification Date | January 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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