Investigating Two Prototype Mobile App Interventions to Increase Physical Activity
Reframing Health Behavior Change: A Randomized Controlled Trial of a Relational Frame Theory (RFT)-Informed Values Intervention for Health
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2024
CompletedFirst Posted
Study publicly available on registry
April 17, 2024
CompletedStudy Start
First participant enrolled
June 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2025
CompletedMay 8, 2025
May 1, 2025
6 months
March 28, 2024
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
International Physical Activity Questionnaire (IPAQ) - Total physical activity
A self-report scale that measures physical activity. The IPAQ comprises 27 items that assess time spent engaging in various levels of physical activity / time spent sitting and participants are asked to report their responses in terms of minutes, hours, or days. Scores can be computed continuously or categorically. Continuous scoring will be used. Total physical activity will be the primary outcome; components of physical activity and sedentary time will be examined as secondary outcomes. The investigators added an additional item at the end of the survey: "Was your physical activity much less than typical this week due to very unusual circumstances such as being sick, moving, unusual travel, being hospitalized, etc.?" Response options were: "Yes - my physical activity this week was much less than typical due to very unusual circumstances", "No - my physical activity was fairly typical despite experiencing very unusual circumstances", and "No - my circumstances were basically normal".
Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Secondary Outcomes (27)
Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Total score
Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Amotivation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3)
Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
External Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3)
Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Introjected Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3)
Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Identified Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3)
Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
- +22 more secondary outcomes
Study Arms (2)
Values Clarification Condition
EXPERIMENTALParticipants 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.
Self-Reflection Condition
PLACEBO COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age between 18 and 65 years old.
- Living in the United States
- Own a device that can receive text messages.
- Have reliable internet access.
- Want to increase physical activity.
You may not qualify if:
- Below 18 or above 65 years old.
- Living outside the United States
- Not owning a device that can receive text messages.
- Not having reliable internet access.
- Not interested in increasing physical activity.
- Not having the fluency in English sufficient to read or understand study materials.
- Unable to engage in physical activity safely due to medical status.
- Currently in another program focused on increasing physical activity.
- Currently taking medications that cause dizziness or feeling faint while standing (e.g. some hypertension medications).
- Already completing 150 minutes or more of moderate-to-vigorous physical activity most weeks.
- 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.)
- Participants will also be excluded from the study if they are suspected of being a bot or invalid respondent based on their responses.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mindfulness and Acceptance Processes Lab
Starkville, Mississippi, 39759, United States
Related Publications (21)
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BACKGROUNDCraig 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.
PMID: 12900694BACKGROUNDDeci, 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
BACKGROUNDDevilly 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.
PMID: 11132119BACKGROUNDGregoire, 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
BACKGROUNDGuidelines for data processing and analysis of the IPAQ - short and long forms. (2005). IPAQ. https://sites.google.com/view/ipaq/score?authuser=0
BACKGROUNDHahn 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.
PMID: 26931288BACKGROUNDHays 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.
PMID: 19543809BACKGROUNDHealth Measures. (2017). Global Health. http://www.healthmeasures.net/images/PROMIS/manuals/PROMIS_Global_Scoring_Manual.pdf
BACKGROUNDHealth 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
BACKGROUNDKelley, 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.
BACKGROUNDKnell 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.
PMID: 28720556BACKGROUNDKrafft, 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
BACKGROUNDKrafft, 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
BACKGROUNDMarkland, 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
BACKGROUNDMarkland, D. (n. d.). Scoring the BREQ. http://exercise-motivation.bangor.ac.uk/breq/brqscore.php
BACKGROUNDMcLoughlin, 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
BACKGROUNDRaes 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.
PMID: 21584907BACKGROUNDRolffs 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.
PMID: 27152011BACKGROUNDWilson, 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
BACKGROUNDKrafft, 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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Krafft, PhD
Mississippi State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 28, 2024
First Posted
April 17, 2024
Study Start
June 25, 2024
Primary Completion
December 8, 2024
Study Completion
March 18, 2025
Last Updated
May 8, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Within one year of the end of data collection, and remaining available indefinitely.
- Access Criteria
- There are no specific access criteria. The request must have a valid research-related purpose.
The investigators plan to share fully deidentified data sets. Any potentially identifying information including unusual demographics or combinations of demographics will be removed, but all other variables will be available to other researchers, journals or officials on reasonable request.