Effects of Physical Activity Adequacy Mindsets on Health and Wellbeing

Activity Adequacy Mindsets Clinical Trial

Official title:

Harnessing Mindset in 21st Century Healthcare: Leveraging Mindset in Health Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939572
• Other study ID #: 36098
• Secondary ID: DP2AT009511
• Status: Completed
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: November 15, 2019

Study information

• Verified date: January 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Activity Adequacy Mindsets

Intervention

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.
• 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).
• 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).
• 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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 weeks: measured at baseline (onboarding session), in daily and weekly surveys, and at end of study (offboarding session)
Primary	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.	5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session)
Primary	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.	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
Primary	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.	5 weeks: measured at baseline (onboarding session) and end of study (offboarding session)
Primary	Change in Cognitive Function Over 5 Weeks	Stroop task performance	5 weeks: measured at baseline (onboarding session) and end of study (offboarding session)
Secondary	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.	5 weeks: measured at baseline (onboarding session), in daily and weekly surveys, and at end of study (offboarding session)
Secondary	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.	5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session)
Secondary	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.	5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session)
Secondary	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.	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
Secondary	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.	5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session)
Secondary	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.	5 weeks: measured at baseline (onboarding session), in one of the weekly surveys, and at end of study (offboarding session)