Advancing Behavioral Intervention and Theory Development for Mobile Health: The HeartSteps II Protocol
Abstract
:1. Introduction
2. Materials and Methods
2.1. Research Design
2.2. Aims
2.3. HeartSteps Intervention Components
2.3.1. Fitbit
2.3.2. HeartSteps App
2.3.3. HeartSteps Clock Face
2.4. HearSteps Intervention Design: Randomization, Availability and Proximal Outcomes
2.4.1. Motivational Messages
2.4.2. Walking Suggestions
2.4.3. Anti-Sedentary Suggestions
2.5. Measures
2.5.1. Baseline and Follow Up
2.5.2. Ecological Momentary Assessment (EMA)
Daily Questionnaires
Weekly Questionnaires
Activity Questionnaires
EMA Bursts
2.5.3. Passive Measures
The Fitbit Activity Tracker
HeartSteps Use Logs
3. Participants and Procedures
3.1. Recruitment
3.2. Power Calculations
3.3. Eligibility
3.4. Initial Screening, Orientation, and Run-in Procedures
3.5. Participants
3.6. Treatment Fidelity (Monitoring, Contacting Protocol, Adherence)
3.6.1. Monitoring Data Collection
No Fitbit Data
No Interaction with the HeartSteps Application
Morning Survey Non-Compliance
3.7. Burst Adherence Protocol
3.8. Data Storage, Security and Privacy
4. Modeling and Data Analysis
4.1. Analyses of Micro-Randomized Intervention Data
4.2. Modeling Framework Development
4.2.1. Computational Modeling with Dynamic Bayesian Networks
4.2.2. Modeling with Continuous Dynamical Systems
5. Discussion and Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Measures | Answer Categories (Number of Items) |
---|---|
Demographic Information * | Age, Race, Marital Status, Household Members, Employment Status, Level of Education (6 items) |
Autonomy to Decide Schedule * | Strongly Disagree to Strongly agree (3 items) (5-point Likert) |
Mobile Phone Usage * | More than 30 times per day; Between 10 and 30 times per day; Between 5 and 9 times per day; 3 or 4 times per day; 1 or 2 per day; Less frequently than once per day (1 item) |
Ten-Item Personality Inventory (TIPI) [25] * | Disagree strongly to Agree Strongly (10 items) (7-point Likert scale) |
Stress (Perceived Stress Scale—PSS) [26] ^ | Never to very often (5 items) (5-point Likert scale) |
Routine * | Definitely a morning type; Rather more a morning type than an evening type; Rather more an evening-type than a morning-type; Definitely an evening type (1 item) |
Self-efficacy for Physical Activity [27] ^ | Not at all confident to extremely confident (5 items) (5-point Likert) |
Motivation for Physical Activity [28] ^ | Not true for me to very true for me (19 items) (5-point Likert) |
Value of Physical Activity [29] * | Extremely worthless to Extremely valuable (1 item) (5-point Likert) |
Intention in Physical Activity [30] * | Not at all to very much (1 item) (5-point Likert) |
Perceived Effects of Physical Activity ^ | How long does it take before you notice the positive (3 items)/negative (3 items) effects of physical activity on; emotional well-being, physical heath, mood |
Social Support in Physical Activity ^ | Never true, sometimes true, always true, not applicable (6 items) |
Neighborhood Walkability [31] * | Strongly disagree to strongly agree (6 items) (4-point Likert) |
Social Isolation Index [32] * | Rarely or never, once a month, several times a month, at least once a week (6 items) |
Physical Activity During COVID-19 Outbreak [33] + | Yes, no, decline to answer (3 items) |
App Usability (Mobile App Rating Scale (MARS) [34] + | Item specific answer categories (20 items) |
Morning Questionnaire (Once Daily, Available after 6:00 a.m.) | ||||
---|---|---|---|---|
Item | Answer Categories | * Current | Pro-Spective | Retro-Spective |
How well rested do you feel this morning? | Not at all—Very (5-pt. Likert) | X | ||
How busy is your day going to be today? | Not at all—Very (5-pt. Likert) | X | ||
If I walk or exercise today, it’s because it’s important to my life | Not at all true—Very true (5-pt. Likert) | X | ||
If I walk or exercise today, it’s because other people think I should | Not at all true—Very true (5-pt. Likert) | X | ||
How committed do you feel this morning in being physically active today | Not at all—Very (5-pt. Likert) | X | ||
Which of these best describes how you feel this morning | (Choose one) sad, energetic, stressed, relaxed, fatigued, happy, tense | X | ||
Weekly questionnaire (once a week, available Sunday) | ||||
People in my life supported me in my efforts to be more active this past week (not at all true to very true | Not at all true—Very true (5-pt. Likert) | X | ||
How much are you enjoying physical activities you did this week? | Not at all—Very much (5-pt. Likert) | X | ||
Over the past week, how socially connected you felt? | Not at all—Extremely (5-pt. Likert) | X | ||
This week, I walked or exercised because I felt restless, stressed, or in a bad mood | Not at all true—Very true (5-pt. Likert) | X | ||
How well is physical activity currently fitting into your daily routine | Not at all—Very much (5-pt. Likert) | X | ||
This past week, I walked or exercised because other people think I should | Not at all true—Very true (5-pt. Likert) | X | ||
This past week, I walked or exercised because it’s important for my life | Not at all—Very much (5-pt. Likert) | X | ||
Over the past week, how lonely have you felt? | Not at all—Extremely (5-pt. Likert) | X | ||
Did any of the following make it difficult for you to be active this week? (Barriers) | (Check all that apply) illness or injury; poor weather; sore muscles; no time/too busy; no place to be active; personal safety; traffic safety; travel, open response category | X | ||
Is this barrier likely to continue into next week? | (Choose one) Yes, No, I don’t know | X | ||
How confident are you that you’ll reach your goal | Not at all—Very much (5-pt. Likert) | X | X | |
Activity Questionnaires (outside of burst weeks, probability of 0.1 after activity is detected) | ||||
How much did you enjoy the activity you just did? | Not at all—Very much (5-pt. Likert) | X | ||
How well did this activity fit into your day? | Not at all—Very much (5-pt. Likert) | X | ||
I did this activity … | (Choose one) alone, with friends, with family, with colleagues, with someone else | X | ||
I did this activity partly because I wanted to be more active | Not at all true—Very true (5-pt. Likert) | X | ||
I did this activity because other people thought I should | Not at all true—Very true (5-pt. Likert) | X | ||
EMA Bursts—once every three months for seven days | ||||
Activity questionnaires (see above) after completion of each detected activity | ||||
Walking suggestion questionnaires (see below) five times per day | ||||
How busy are you right now? | Not at all—Very (5-pt. Likert) | X | ||
Right now, how relaxed do you feel? | Not at all—Very (5-pt. Likert) | X | ||
Right now, how tense do you feel? | Not at all—Very (5-pt. Likert) | X | ||
Right now, how energetic do you feel? | Not at all—Very (5-pt. Likert) | X | ||
Right now, how fatigued do you feel? | Not at all—Very (5-pt. Likert) | X | ||
Right now, how happy do you feel? | Not at all—Very (5-pt. Likert) | X | ||
Right now, how sad do you feel? | Not at all—Very (5-pt. Likert) | X | ||
Right now, how stressed do you feel? | Not at all—Very (5-pt. Likert) | X | ||
How committed do you feel right now to being physically active today? | Not at all—Very (5-pt. Likert) | X | ||
Given what’s going on right now, I will be able to be active in the next hour. | Strongly disagree—Strongly agree (5-pt. Likert) | X |
Inclusion Criteria |
---|
BMI between 25–45 kg/m2 |
18–65 years of age |
Competent to give informed consent |
Own either an iPhone with iOS 6 or above or an Android phone with Version 7 or above. |
Willing to participate in the study protocols including |
Regularly carrying a mobile phone |
Using the HeartSteps application using the HeartSteps application, |
Answering phone-based questionnaires |
Wear the Fitbit Versa activity tracker at least 8 h a day. |
Fluent in English |
Residing in Southern California |
Exclusion Criteria |
Mentally incapable of giving informed consent, |
Psychiatric disorder that limits the patients’ ability to follow study protocol, including psychosis and dementia. |
Non-English speaking |
Orthopedic problems that prevent participation in a walking program |
Significant peripheral neuropathy |
Vigorous Activity that spans at least three days and leads to a total of at least 1500 MET min or 7 or more days of any combo of exercises that exceeds a total of 3000 MET min (Based on IPAQ scoring) |
Demographics | Participants: |
---|---|
Gender | |
Male | 23 |
Female | 72 |
Age | |
18–20 | 2 |
21–34 | 37 |
35–44 | 25 |
45–65 | 31 |
Race/Ethnicity | |
American Indian/Alaska Native | 2 |
Asian | 19 |
Black or African American | 4 |
White | 48 |
Middle Eastern | 2 |
Hispanic/Latinx | 39 |
More Than One Race | 5 |
Other | 10 |
Prefer not to respond | 5 |
Level of education | |
Some High school | 1 |
High school graduate/diploma/GED | 5 |
Some College or 2 year Degree | 27 |
Bachelor’s degree (BS/BA/AB) | 31 |
Some Graduate School | 5 |
Graduate degree | 25 |
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Spruijt-Metz, D.; Marlin, B.M.; Pavel, M.; Rivera, D.E.; Hekler, E.; De La Torre, S.; El Mistiri, M.; Golaszweski, N.M.; Li, C.; Braga De Braganca, R.; et al. Advancing Behavioral Intervention and Theory Development for Mobile Health: The HeartSteps II Protocol. Int. J. Environ. Res. Public Health 2022, 19, 2267. https://doi.org/10.3390/ijerph19042267
Spruijt-Metz D, Marlin BM, Pavel M, Rivera DE, Hekler E, De La Torre S, El Mistiri M, Golaszweski NM, Li C, Braga De Braganca R, et al. Advancing Behavioral Intervention and Theory Development for Mobile Health: The HeartSteps II Protocol. International Journal of Environmental Research and Public Health. 2022; 19(4):2267. https://doi.org/10.3390/ijerph19042267
Chicago/Turabian StyleSpruijt-Metz, Donna, Benjamin M. Marlin, Misha Pavel, Daniel E. Rivera, Eric Hekler, Steven De La Torre, Mohamed El Mistiri, Natalie M. Golaszweski, Cynthia Li, Rebecca Braga De Braganca, and et al. 2022. "Advancing Behavioral Intervention and Theory Development for Mobile Health: The HeartSteps II Protocol" International Journal of Environmental Research and Public Health 19, no. 4: 2267. https://doi.org/10.3390/ijerph19042267
APA StyleSpruijt-Metz, D., Marlin, B. M., Pavel, M., Rivera, D. E., Hekler, E., De La Torre, S., El Mistiri, M., Golaszweski, N. M., Li, C., Braga De Braganca, R., Tung, K., Kha, R., & Klasnja, P. (2022). Advancing Behavioral Intervention and Theory Development for Mobile Health: The HeartSteps II Protocol. International Journal of Environmental Research and Public Health, 19(4), 2267. https://doi.org/10.3390/ijerph19042267