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Trial record 2 of 58 for:    MINDSET

Effects of Physical Activity Adequacy Mindsets on Health and Wellbeing

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ClinicalTrials.gov Identifier: NCT03939572
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Alia Crum, Stanford University

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.

Condition or disease Intervention/treatment Phase
Psychological Mindsets About Physical Activity Behavioral: Accurate step count feedback Behavioral: Deflated step count feedback Behavioral: Inflated step count feedback Behavioral: Accurate feedback + mindset intervention Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine


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.

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).

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).

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.





Primary Outcome Measures :
  1. Change in Perceived Amount of Exercise Over 5 Weeks [ Time Frame: 5 weeks: measured at baseline (onboarding session), in daily and weekly surveys, and at end of study (offboarding session) ]
    Perceived Amount of Exercise (manipulation check), measured via 1-item self-report in all surveys. The full item is "Overall, how much exercise did you get today?", range 1 (None at all) - 5 (A great deal), with high values considered a better outcome.

  2. Change in Activity Adequacy Mindset Over 5 Weeks [ Time Frame: 5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session) ]
    Activity Adequacy Mindset (key mediator) measured via self-report in onboarding/ offboarding surveys (7 items) and weekly surveys (shortened, 5 items). This scale ranges from 1 - 7, with higher values representing better outcomes. The items will be combined in a composite score by averaging.

  3. Change in Physical Health Over 5 Weeks [ Time Frame: 5 weeks: measured at baseline (onboarding session) and end of study (offboarding session); except average daily heart rate, which is based on Apple Watch HR recordings measured approx. every 20 minutes when participant is wearing watch during the 5 weeks ]
    Physical Health measures are BMI (calculated from self-reported height and weight measured in lab, BMI = kg/m^2); Body fat percentage (measured on lab scale); Resting systolic and diastolic blood pressure (measured in lab); Resting heart rate (HR) (measured in lab); Average daily heart rate (measured by Apple Watch heart rate sensor); VO2max, approximated through the Canadian Home Fitness Test (based on post-exercise HR measured in lab); Perceived general health (measured via 1-item self-report); Perceived fitness (measured via 1-item self-report); Physical function and pain (measured via PROMIS-29 Profile v2.0 questionnaire). All measures will be factor analyzed and combined into a summary score (average of standardized scores weighted by variables' factor loading), provided factor analysis shows that they load onto one factor (i.e., rotated factor loadings of >= |0.4|). Measures will also be analyzed separately for exploratory purposes.

  4. Change in Mental Health Over 5 Weeks [ Time Frame: 5 weeks: measured at baseline (onboarding session) and end of study (offboarding session) ]
    Anxiety, depressive symptoms, ability to participate in social roles and activities, sleep disturbance, fatigue (measured via PROMIS (Patient-Reported Outcomes Measurement Information System)-29 Profile v2.0 questionnaire), and stress (measured via Perceived Stress Scale, PSS). Each PROMIS subscale ranges from 1-5, with higher values representing better outcomes. Items will be averaged into subscale composite scores. The PSS ranges from 1-5, with higher values representing worse outcomes. PSS items will be averaged into a composite score. All measures will be factor analyzed and combined into a summary score (average of standardized scores weighted by variables' factor loading), provided factor analysis shows that they load onto one factor (i.e., rotated factor loadings of >= |0.4|). Measures will also be analyzed separately for exploratory purposes.

  5. Change in Cognitive Function Over 5 Weeks [ Time Frame: 5 weeks: measured at baseline (onboarding session) and end of study (offboarding session) ]
    Stroop task performance


Secondary Outcome Measures :
  1. Change in Affect Over 5 Weeks [ Time Frame: 5 weeks: measured at baseline (onboarding session), in daily and weekly surveys, and at end of study (offboarding session) ]
    Measured via self-report (Affect Valuation Index, AVI, and 2 items measuring stress/ anxiety). AVI items range from 1-5, with higher scores indicating higher frequency of any given emotion. Items will be averaged into 8 subscale composite scores according to the AVI protocol by averaging. Items measuring stress/ anxiety range from 1-5 with higher scores representing worse outcomes. All measures will be factor analyzed and combined into a summary score (average of standardized scores weighted by variables' factor loading), provided factor analysis shows that they load onto one factor (i.e., rotated factor loadings of >= |0.4|). Measures will also be analyzed separately for exploratory purposes.

  2. Change in Self-Efficacy for Exercise Over 5 Weeks [ Time Frame: 5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session) ]
    Measured via self-report (Self-Efficacy for Exercise scale). Items range from 1-5, with higher values representing better outcomes. Items will be averaged into a composite scale.

  3. Change in Motivation for exercise and health promotion Over 5 Weeks [ Time Frame: 5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session) ]
    Measured via self-report (2 items measuring exercise motivation and health promotion motivation). Items range from 1-5, with higher values representing better outcomes. Items will be averaged into a composite scale.

  4. Change in Physical Activity Behavior Over 5 Weeks [ Time Frame: 5 weeks: Step count measured by Apple Watch every ~ 15 min when participant is wearing watch during the 5 weeks; IPAQ and custom physical activity measure assessed in onboarding/ offboarding sessions, and the latter also in weekly surveys ]
    Physical activity is measured via daily step count tracked by Apple Watch, and via self-report (IPAQ, and a measure adapted from NHANES for this study). All measures will be factor analyzed and combined into a summary score (average of standardized scores weighted by variables' factor loading), provided factor analysis shows that they load onto one factor (i.e., rotated factor loadings of >= |0.4|). Measures will also be analyzed separately for exploratory purposes.

  5. Change in Other Health Behaviors (diet, sleep, drinking, smoking) Over 5 Weeks [ Time Frame: 5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session) ]
    Measured via self-report (9 items). All measures will be factor analyzed and combined into a summary score (average of standardized scores weighted by variables' factor loading), provided factor analysis shows that they load onto one factor (i.e., rotated factor loadings of >= |0.4|). Measures will also be analyzed separately for exploratory purposes.

  6. Change in Process Mindset Over 5 Weeks [ Time Frame: 5 weeks: measured at baseline (onboarding session), in one of the weekly surveys, and at end of study (offboarding session) ]
    Exercise process mindset and Health process mindset are measured via self-report (7 items per scale). Items range from 1-4, with higher values representing better outcomes. Items will be averaged into two composite scores (General Process Mindset and Exercise Process Mindset). If items from both subscales have sufficient reliability (Cronbach's alpha > 0.7), they will be averaged into one composite scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Low level of physical activity in the prior six months, as indicated by self-report
  • Walking as primary source of physical activity in the prior six months, as indicated by self-report
  • Ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria:

  • Candidates who answer affirmatively to any of the Physical Activity Readiness Questionnaire (PAR-Q) items will be excluded, unless they get clearance from a physician that they are able to participate in the study.
  • Candidates who report pregnancy will be excluded, as natural changes in weight and body composition during pregnancy would invalidate our results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939572


Contacts
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Contact: Alia J Crum, PhD 650-725-2418 crum@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Alia J Crum, PhD         
Sponsors and Collaborators
Stanford University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Alia J Crum, PhD Stanford University

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Responsible Party: Alia Crum, Assistant Professor of Psychology, Stanford University
ClinicalTrials.gov Identifier: NCT03939572     History of Changes
Other Study ID Numbers: 36098
DP2AT009511 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If made publicly available, all data will be de-identified and the anonymous data will be shared with researchers on the Open Science Framework

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alia Crum, Stanford University:
Psychological mindsets
Physical activity
Wearable fitness trackers