Investigating Two Prototype Mobile App Interventions to Increase Physical Activity

NCT ID: NCT06372275

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-25
• Study Completion Date: 2025-03-18

Brief Summary

This randomized control trial aims to investigate whether writing about personal values helps enhance motivation to engage in physical activity, relative to general self-reflective writing. This study will help to (1) assess whether values clarification leads to increased motivation to engage in physical activity, greater stability in motivation, and improvements in engagement in physical activity and valued action, relative to engaging in self-reflection, (2) determine if the impact of values clarification on these outcomes vary depending on context (e.g., positive/negative affect, psychological inflexibility, stressful events), (3) explore whether values clarification procedures that employ distinct relational frames (hierarchical, conditional, distinction, and deictic) differentially impact motivation to engage in physical activity, and daily engagement in physical activity, and (4) explore whether the impact of values clarification vary depending on baseline self-compassion and/or intrinsic/extrinsic motivation.

Detailed Description

This randomized control trial study aims to investigate the efficacy of a values clarification prototype mobile application intervention in increasing physical activity and enhancing motivation to exercise in a general, adult sample. Participants will be recruited using a variety of recruitment methods (e.g., Google Ads, posts on relevant online groups such as Facebook groups, posting flyers, and provider referrals). Interested participants will first complete an online pre-screening asking whether they are between the ages of 18 and 65, reside in the United States, want to increase their physical activity, own a device that can receive text messages, and have reliable internet access. Participants will also be asked about why they want to participate in the study, about their current level of physical activity and how they hope to change it, and about how they learned about the study. Those who meet the eligibility criteria in the pre-screening will be directed to review an online informed consent form. Those who indicate that they consent will be directed to provide their contact information (name, email, and phone number). A trained research assistant will call the participant to ask additional screening questions assessing all exclusion criteria (listed later in this registration). Eligible participants at this stage will be redirected to complete a baseline survey and then be randomly assigned to either the: (1) Experimental group with the values clarification mobile application or (2) the control group with the self-reflection mobile application. Participants will have access to the app hosted on Qualtrics for 28 days. They will first complete a tutorial, and then begin completing the daily surveys in addition to the writing prompts. Participants will receive daily text message reminders to use the app at a time that they specify. Four weeks after baseline, participants will be asked to complete a post-treatment survey and eight weeks after baseline, participants will be asked to complete a final, follow-up survey. Participants will be given the opportunity to use the alternative app at the end of the study.

Conditions

Health-Related Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Values Clarification Condition

Participants will respond to values clarification writing prompts related to physical exercise once a day over 28 days in addition to a short daily survey. In each session, one writing prompt will be randomly presented from a pool of four categories: hierarchical, conditional, distinction, and perspective-taking. The survey inquires about time spent doing light, moderate, and vigorous exercise the day before, in addition to time spent watching television, using the computer, and sitting. It also includes the 24 item Multidimensional Psychological Flexibility Inventory adapted for ecological momentary assessment and questions asking participants to rate the extent to which they currently feel 8 emotions, their current motivation to exercise, and their stress yesterday. The writing prompt and survey are estimated to take 10 minutes to complete daily. Participants will have the option to review additional educational content about values and their previous written responses.

Group Type: EXPERIMENTAL

Values Clarification Mobile Application

Intervention Type: BEHAVIORAL

Participants in the intervention group will be asked to answer a series of values clarification writing prompts related to physical activity once a day over four weeks.

Self-Reflection Condition

Participants in this condition will be asked to respond to one randomly selected self-reflection prompt about physical activity from a library of 28 prompts once a day over 28 days \[4 weeks\]. As with the experimental condition, participants will also complete the same daily survey which includes questions about how many minutes they spent doing light, moderate, and vigorous exercise the day before, in addition to how many hours they spent watching television, using the computer, and sitting. The survey also contains the 24 item Multidimensional Psychological Flexibility Inventory adapted for ecological momentary assessment and questions asking participants to rate the extent to which they are currently feeling 8 emotions, their current motivation to exercise, and their stress the day before. This is estimated to take 10 minutes to complete daily. Participants will have the option to review additional educational content about values clarification and their previous written responses.

Group Type: PLACEBO_COMPARATOR

Self-Reflection Mobile Application

Intervention Type: BEHAVIORAL

Participants in the control group will be administered writing prompts in the same format and frequency as the values intervention, but with prompts focused on self-reflection related to physical activity.

Interventions

Values Clarification Mobile Application

Participants in the intervention group will be asked to answer a series of values clarification writing prompts related to physical activity once a day over four weeks.

Intervention Type: BEHAVIORAL

Self-Reflection Mobile Application

Participants in the control group will be administered writing prompts in the same format and frequency as the values intervention, but with prompts focused on self-reflection related to physical activity.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 65 years old.

2. Living in the United States

3. Own a device that can receive text messages.

4. Have reliable internet access.

5. Want to increase physical activity.

Exclusion Criteria

1. Below 18 or above 65 years old.

2. Living outside the United States

3. Not owning a device that can receive text messages.

4. Not having reliable internet access.

5. Not interested in increasing physical activity.

6. Not having the fluency in English sufficient to read or understand study materials.

7. Unable to engage in physical activity safely due to medical status.

8. Currently in another program focused on increasing physical activity.

9. Currently taking medications that cause dizziness or feeling faint while standing (e.g. some hypertension medications).

10. Already completing 150 minutes or more of moderate-to-vigorous physical activity most weeks.

11. Report any condition that would preclude adherence to the intervention protocol (e.g. current or past substance use disorder or psychiatric hospitalization, terminal illness diagnosis.)

12. Participants will also be excluded from the study if they are suspected of being a bot or invalid respondent based on their responses.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association for contextual behavioral science

UNKNOWN

Sponsor Role: collaborator

Mississippi State University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Krafft

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Krafft, PhD

Role: PRINCIPAL_INVESTIGATOR

Mississippi State University

Locations

Mindfulness and Acceptance Processes Lab

Starkville, Mississippi, United States

Countries

United States

References

Bangor, A., Kortum, P. T., & Miller, J. T. (2008). An empirical evaluation of the system usability scale. Intl. Journal of Human-Computer Interaction, 24(6), 574-594. https://doi.org/10.1080/10447310802205776

Reference Type: BACKGROUND

Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

Reference Type: BACKGROUND

PMID: 12900694 (View on PubMed)

Deci, E. L., & Ryan, R. M. (1985). The general causality orientations scale: Self-determination in personality. Journal of research in personality, 19(2), 109-134. https://doi.org/10.1016/0092-6566(85)90023-6

Reference Type: BACKGROUND

Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

Reference Type: BACKGROUND

PMID: 11132119 (View on PubMed)

Gregoire, S., Gagnon, J., Lachance, L., Shankland, R., Dionne, F., Kotsou, I., Monestès, J. L., Rolffs, J. L., & Rogge, R. D. (2020). Validation of the English and French versions of the multidimensional psychological flexibility inventory short form (MPFI-24). Journal of contextual behavioral science, 18, 99-110. https://doi.org/10.1016/j.jcbs.2020.06.004

Reference Type: BACKGROUND

Guidelines for data processing and analysis of the IPAQ - short and long forms. (2005). IPAQ. https://sites.google.com/view/ipaq/score?authuser=0

Reference Type: BACKGROUND

Hahn EA, Beaumont JL, Pilkonis PA, Garcia SF, Magasi S, DeWalt DA, Cella D. The PROMIS satisfaction with social participation measures demonstrated responsiveness in diverse clinical populations. J Clin Epidemiol. 2016 May;73:135-41. doi: 10.1016/j.jclinepi.2015.08.034. Epub 2016 Feb 27.

Reference Type: BACKGROUND

PMID: 26931288 (View on PubMed)

Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.

Reference Type: BACKGROUND

PMID: 19543809 (View on PubMed)

Health Measures. (2017). Global Health. http://www.healthmeasures.net/images/PROMIS/manuals/PROMIS_Global_Scoring_Manual.pdf

Reference Type: BACKGROUND

Health Measures. (2014). Satisfaction With Social Roles and Activities. https://www.healthmeasures.net/images/promis/manuals/PROMIS_Satisfaction_with_Participation_in_Social_Roles_Scoring_Manual.pdf

Reference Type: BACKGROUND

Kelley, M. L., Heffer, R. W., Gresham, F. M., & Elliott, S. N. (1989). Development of a modified treatment evaluation inventory. Journal of psychopathology and behavioral assessment, 11, 235-247.

Reference Type: BACKGROUND

Knell G, Gabriel KP, Businelle MS, Shuval K, Wetter DW, Kendzor DE. Ecological Momentary Assessment of Physical Activity: Validation Study. J Med Internet Res. 2017 Jul 18;19(7):e253. doi: 10.2196/jmir.7602.

Reference Type: BACKGROUND

PMID: 28720556 (View on PubMed)

Krafft, J., Middleton, A., & Tadros, N. (2024). Is the Multidimensional Psychological Flexibility Inventory valid for ecological momentary assessment? A preliminary psychometric investigation. [Manuscript in preparation]. Department of Psychology, Mississippi State University

Reference Type: BACKGROUND

Krafft, J., & Levin, M. E. (2021). Does the Cognitive Fusion Questionnaire measure more than frequency of negative thoughts?. Journal of Contextual Behavioral Science, 22, 63-67. https://doi.org/10.1016/j.jcbs.2021.09.002

Reference Type: BACKGROUND

Markland, D., & Tobin, V. (2004). A modification to the behavioural regulation in exercise questionnaire to include an assessment of amotivation. Journal of Sport and Exercise Psychology, 26(2), 191-196. https://doi.org/10.1123/jsep.26.2.191

Reference Type: BACKGROUND

Markland, D. (n. d.). Scoring the BREQ. http://exercise-motivation.bangor.ac.uk/breq/brqscore.php

Reference Type: BACKGROUND

McLoughlin, S., Stapleton, A., & Hochard, K. D. (2022). Development and preliminary validation of the Value Clarity Questionnaire. PsyArXiv. https://doi.org/10.31234/osf.io/u97q3

Reference Type: BACKGROUND

Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

Reference Type: BACKGROUND

PMID: 21584907 (View on PubMed)

Rolffs JL, Rogge RD, Wilson KG. Disentangling Components of Flexibility via the Hexaflex Model: Development and Validation of the Multidimensional Psychological Flexibility Inventory (MPFI). Assessment. 2018 Jun;25(4):458-482. doi: 10.1177/1073191116645905. Epub 2016 May 5.

Reference Type: BACKGROUND

PMID: 27152011 (View on PubMed)

Wilson, P. M., Rodgers, W. M., Loitz, C. C., & Scime, G. (2006). It's Who I Am...Really! The Importance of Integrated Regulation in Exercise Contexts. Journal of Applied Biobehavioral Research, 11(2), 79-104. https://doi.org/10.1111/j.1751-9861.2006.tb00021.x

Reference Type: BACKGROUND

Krafft, J., Klimczak, K. S., & Levin, M. E. (2022). Effects of cognitive restructuring and defusion for coping with difficult thoughts in a predominantly white female college student sample. Cognitive Therapy and Research, 46(1), 86-94.

Reference Type: BACKGROUND

Other Identifiers

0000

Identifier Type: -

Identifier Source: org_study_id