Activity Adequacy MindsetsNCT03939572
Effects of Physical Activity Adequacy Mindsets on Health and Wellbeing
A study testing Accurate step count feedback, Deflated step count feedback and Inflated step count feedback in people with Activity Adequacy Mindsets, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Activity Adequacy Mindsets
- What is being tested?
- Accurate step count feedback, Deflated step count feedback and Inflated step count feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 15 Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Harnessing Mindset in 21st Century Healthcare: Leveraging Mindset in Health Technology
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.
Read the 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.
- Conditions
- Activity Adequacy Mindsets
- Being tested
- Accurate step count feedback, Deflated step count feedback, Inflated step count feedback, Accurate feedback + mindset intervention
- Keywords
- Psychological mindsets, Physical activity, Wearable fitness trackers
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accurate step count feedbackBehavioural
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.
Deflated step count feedbackBehavioural
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).
Inflated step count feedbackBehavioural
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).
Accurate feedback + mindset interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Accurate step count feedback | Active comparator | 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. Receives: Behavioral: Accurate step count feedback |
| Deflated step count feedback | Experimental | 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. Receives: Behavioral: Deflated step count feedback |
| Inflated step count feedback | Experimental | 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. Receives: Behavioral: Inflated step count feedback |
| Accurate feedback + mindset intervention | Experimental | 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. Receives: Behavioral: Accurate feedback + mindset intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Amount of Exercise Over 5 Weeks
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.
Measured: 5 weeks: measured at baseline (onboarding session), in daily and weekly surveys, and at end of study (offboarding session)
Change in Activity Adequacy Mindset Over 5 Weeks
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.
Measured: 5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session)
Change in Physical Health Over 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.
Measured: 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
Change in Mental Health Over 5 Weeks
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.
Measured: 5 weeks: measured at baseline (onboarding session) and end of study (offboarding session)
Change in Cognitive Function Over 5 Weeks
Stroop task performance
Measured: 5 weeks: measured at baseline (onboarding session) and end of study (offboarding session)
Secondary outcomes (6)
Change in Affect Over 5 Weeks
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.
Measured: 5 weeks: measured at baseline (onboarding session), in daily and weekly surveys, and at end of study (offboarding session)
Change in Self-Efficacy for Exercise Over 5 Weeks
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.
Measured: 5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session)
Change in Motivation for exercise and health promotion Over 5 Weeks
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.
Measured: 5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session)
Change in Physical Activity Behavior Over 5 Weeks
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.
Measured: 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
Change in Other Health Behaviors (diet, sleep, drinking, smoking) Over 5 Weeks
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.
Measured: 5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session)
Change in Process Mindset Over 5 Weeks
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.
Measured: 5 weeks: measured at baseline (onboarding session), in one of the weekly surveys, and at end of study (offboarding session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start30 May 2018
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Activity Adequacy MindsetsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Alia Crum, Stanford University
- Investigators
- Alia J Crum, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939572
- Sponsor's protocol ID
- 36098
- Other IDs
- DP2AT009511
- Status last verified
- Jan 2020
- First submitted
- 11 Apr 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If made publicly available, all data will be de-identified and the anonymous data will be shared with researchers on the Open Science Framework
Publications
Zahrt OH, Evans K, Murnane E, Santoro E, Baiocchi M, Landay J, Delp S, Crum A. Effects of Wearable Fitness Trackers and Activity Adequacy Mindsets on Affect, Behavior, and Health: Longitudinal Randomized Controlled Trial. J Med Internet Res. 2023 Jan 25;25:e40529. doi: 10.2196/40529.
PubMed 36696172
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Mindset in 21st Century Healthcare: Leveraging Mindset in Health Technology
- ClinicalTrials.gov ID
- NCT03939572
- Acronym / sponsor ID
- 36098
- Conditions
- Activity Adequacy Mindsets
- Keywords
- Psychological mindsets, Physical activity, Wearable fitness trackers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 30 May 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 7 May 2019 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Accurate step count feedback | Active comparator | Behavioral: Accurate step count feedbackAll 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. |
| Deflated step count feedback | Experimental | Behavioral: Deflated step count feedbackAll 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. |
| Inflated step count feedback | Experimental | Behavioral: Inflated step count feedbackAll 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. |
| Accurate feedback + mindset intervention | Experimental | Behavioral: Accurate feedback + mindset interventionAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Accurate step count feedbackAfter 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. | Behavioural | Accurate step count feedback |
| Deflated step count feedbackAfter 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). | Behavioural | Deflated step count feedback |
| Inflated step count feedbackAfter 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). | Behavioural | Inflated step count feedback |
| Accurate feedback + mindset interventionAfter 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. | Behavioural | Accurate feedback + mindset intervention |
Primary outcome
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.
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.
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.
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.
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
6 secondary outcomes
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)
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)
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)
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
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)
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)
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 30 Jan 2020.
- Derived from this study: PubMed 36696172Zahrt OH, Evans K, Murnane E, Santoro E, Baiocchi M, Landay J, Delp S, Crum A. Effects of Wearable Fitness Trackers and Activity Adequacy Mindsets on Affect, Behavior, and Health: Longitudinal Randomized Controlled Trial. J Med Internet Res. 2023 Jan 25;25:e40529. doi: 10.2196/40529.
- Individual participant dataSharing planned: Undecided. If made publicly available, all data will be de-identified and the anonymous data will be shared with researchers on the Open Science Framework
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.
Alia J Crum, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accurate step count feedback, Deflated step count feedback and Inflated step count feedback in people with Activity Adequacy Mindsets, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 30 Jan 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 United States. 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?
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)). The study lists 5 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 NCT03939572, which also lists 1 linked publication.
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 30 Jan 2020.