NCT06372275

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 25, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2025

Completed
Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

March 28, 2024

Last Update Submit

May 5, 2025

Conditions

Keywords

Physical ActivityExerciseValues ClarificationSelf-ReflectionAcceptance and Commitment TherapyMobile AppMotivation

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

EXPERIMENTAL

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.

Behavioral: Values Clarification Mobile Application

Self-Reflection Condition

PLACEBO COMPARATOR

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.

Behavioral: Self-Reflection Mobile Application

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.

Values Clarification Condition

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.

Self-Reflection Condition

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Related Publications (21)

  • 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

    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.

    PMID: 12900694BACKGROUND
  • 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

    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.

    PMID: 11132119BACKGROUND
  • 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

    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

    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.

    PMID: 26931288BACKGROUND
  • 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.

    PMID: 19543809BACKGROUND
  • Health Measures. (2017). Global Health. http://www.healthmeasures.net/images/PROMIS/manuals/PROMIS_Global_Scoring_Manual.pdf

    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

    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.

    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.

    PMID: 28720556BACKGROUND
  • 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

    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

    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

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

    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

    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.

    PMID: 21584907BACKGROUND
  • 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.

    PMID: 27152011BACKGROUND
  • 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

    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.

    BACKGROUND

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jennifer Krafft, PhD

    Mississippi State University

    PRINCIPAL INVESTIGATOR

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

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.

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.

Locations