Harnessing Mindset in 21st Century Healthcare: Leveraging Mindset in Health Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Change in Cognitive Function Over 5 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Cognitive Function Over 5 Weeks
时间窗: 5 weeks: measured at baseline (onboarding session) and end of study (offboarding session)
Stroop task performance
Change in Perceived Amount of Exercise Over 5 Weeks
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in Motivation for exercise and health promotion Over 5 Weeks(5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session))
- Change in Self-Efficacy for Exercise Over 5 Weeks(5 weeks: measured at baseline (onboarding session), in weekly surveys, and at end of study (offboarding session))
- Change in Affect Over 5 Weeks(5 weeks: measured at baseline (onboarding session), in daily and weekly surveys, and at end of study (offboarding session))
- Change in Other Health Behaviors (diet, sleep, drinking, smoking) Over 5 Weeks(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(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 Process Mindset Over 5 Weeks(5 weeks: measured at baseline (onboarding session), in one of the weekly surveys, and at end of study (offboarding session))
研究者
Alia Crum
Assistant Professor of Psychology
Stanford University