Investigating Two Prototype Mobile App Interventions to Increase Physical Activity

Not Applicable

Completed

• Conditions: Health-Related Behavior
• Interventions: Behavioral: Values Clarification Mobile Application; Behavioral: Self-Reflection Mobile Application

• Registration Number: NCT06372275
• Lead Sponsor: Mississippi State University

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.

Study Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Study Start: 2024-06-25
• Primary Completion: 2024-12-08
• Study Completion: 2025-03-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Values Clarification Condition	Values Clarification Mobile Application	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.
Self-Reflection Condition	Self-Reflection Mobile Application	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.

Primary Outcome Measures

Name	Time	Method
International Physical Activity Questionnaire (IPAQ) - Total physical activity	Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)	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".

Secondary Outcome Measures

Name	Time	Method
Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Total score	Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)	A self-report scale that measures an individual's motivation to exercise according to self-determination theory (SDT). The BREQ-3 consists of 24 items that are rated on a scale from 0 (not true for me) to 4 (very true for me). Scores range from a minimum of 0.0 to a maximum of 4.0 for each motivation type, with higher scores indicating a greater level of endorsement of the specific motivation dimension. A global score called the Relative Autonomy Index can be calculated.
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)	The "Amotivation" subscale of the BREQ-3 refers to a non-self-determined form of regulation, where there is no intention at all to engage in exercise. A sample item is "I don't see why I should have to exercise."
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)	The "External Regulation" subscale of the BREQ-3 refers to motivation that is externally regulated by compliance, conformity, or external rewards and punishment and that is not self-determined. A sample item is "I exercise because other people say I should."
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)	The "Identified Regulation" subscale of the BREQ-3 refers to motivation that is based on the conscious acceptance of exercise as a personal value that overrides any difficulties or obstacles in its way. A sample item is "I think it is important to make the effort to exercise regularly."
Intrinsic 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)	The "Intrinsic Regulation" subscale of the BREQ-3 refers to motivation to exercise that is entirely motivated by interest and enjoyment inherent in exercise itself. It is fully self-motivated and self-determined. A sample item is "I get pleasure and satisfaction from participating in exercise."
Global Mental Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System)	Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)	The "Global Mental Health" subscale of the PROMIS Global Health questionnaire v1.2 provides a generic self-assessment of one's mental health. A sample item is "In general, how would you rate your mental health, including your mood and ability to think?"
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)	The "Introjected Regulation" subscale of the BREQ-3 refers to motivation that is driven by self-control, an effort to maintain self-esteem, and/or internal rewards and punishments. A sample item is "I feel guilty when I don't exercise."
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire v1.2	Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)	A self-report scale that measures an individual's general mental, physical, and social health. This scale consists of 10 items, 9 of which are rated on a scale from 1 (poor) to 5 (excellent), and 1 item pertaining to pain that is rated on a scale from 0 (no pain) to 10 (worst pain imaginable). Overall, higher scores indicate better global health. Scores can be calculated using either the HealthMeasures Scoring Service, which uses response pattern scoring, or by using the manual to convert raw scores to t-scores.
Values Clarity Questionnaire (VCQ)	Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)	A self-report scale that measures how well respondents understand and can articulate their values. The VCQ consists of 7 items rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Total scores range from a minimum of 7 to a maximum of 35, with higher scores indicating higher levels of clarity, understanding, and articulation of one's own values.
Credibility & Expectancy Questionnaire (CEQ)	After the app tutorial (approximately 0-1 weeks after baseline)	A self-report measure of the perceived credibility of and expectations toward a treatment. The CEQ consists of 6 items, 3 for Credibility and 3 for Expectancy. An average score ranging from 1 to 9 will be calculated for Credibility, with higher scores a greater perception of the intervention's credibility by the participants. For the expectancy component, an average percentage score will be calculated ranging from 0% to 100%, with higher percentages indicating more positive expectations towards the treatment.
Integrated 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)	The "Integrated Regulation" subscale of the BREQ-3 refers to motivation to exercise that is fully congruent with one's identity. Integrated Regulation is fully self-determined since it is engaged in willingly. However, it is distinguished from intrinsic motivation because the reason behind engaging in the behavior (i.e., exercise) is still for separable outcomes and not for the sake of itself. A sample item is "I exercise because it is consistent with my life goals."
Global Physical Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System)	Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)	The "Global Physical Health" subscale of the PROMIS Global Health questionnaire v1.2 provides a generic self-assessment of one's physical health. A sample item is "In general, how would you rate your physical health?"
Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24)	Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)	The "Contact With Values" subscale of the MPFI-24 falls under the psychological flexibility factor and measures the extent to which an individual is connected to what is important to them in life, giving direction to their actions. Participants are asked to consider the past two weeks when rating their responses, and a sample item is: "I was very in-touch with what is important to me and my life."
Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24)	Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)	The "Lack of Contact With Values" subscale of the MPFI-24 falls under the psychological inflexibility factor and measures the extent to which an individual is disconnected from their values in their daily life. Participants are asked to consider the past two weeks when rating their responses, and a sample item is: "When life got hectic, I often lost touch with the things I value."
Treatment Evaluation Inventory-Short Form (TEI-SF)	Posttreatment (4 weeks after baseline)	A self-report measure of treatment acceptability. The TEI-SF consists of 7 items rated from 1 (strongly disagree) to 5 (strongly agree). Scores range from 7 to 35, with higher scores indicating higher levels of endorsement for treatment acceptability.
Emotion ratings	Daily during 28 days of mobile prototype app intervention	Participants will be asked to rate the extent to which they feel 8 emotions in the present moment. The question is: "Rate how ___ you feel right now". The items are: "Content", "Relaxed", "Enthusiastic", "Joyful", "Anxious", "Angry", "Sad", and "Ashamed". The rating scale provided ranges from 1 (very slightly or not at all) to 5 (very much). As in past studies the investigators have conducted, the scale was adapted to replace "sluggish" with "ashamed."
Previous Day Stress Level	Daily during 28 days of mobile prototype app intervention	Participants will be asked to rate how stressful their day was the day before. The question is: "How stressful was your day yesterday?" The rating scale provided ranges from 1 (not at all) to 7 (extremely).
Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Satisfaction with Social Roles and Activities 8a	Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)	A self-report scale that measures satisfaction with performing one's usual social roles and activities. The scale consists of 8 items that are rated on a scale from 1 (not at all) to 5 (very much). Scores can be calculated using either the Assessment Center Scoring Service, which uses response pattern scoring, or by using the manual to convert raw scores to t-scores. Higher scores indicate better satisfaction with one's social role and activities.
Self-Compassion Scale Short Form (SCS-SF)	Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)	A self-report scale that measures global self-compassion across six factors: self-kindness, self-judgment, common humanity, isolation, and mindfulness. The SCS-SF consists of 12 items rated on a scale from 1 (almost never) to 5 (almost always). Total scores range from a minimum of 1.0 to a maximum of 5.0, with higher scores indicating greater levels of self-compassion.
Momentary Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA)	Daily during 28 days of mobile prototype app intervention]	The "Contact With Values" subscale of the MPFI-4 adapted for EMA falls under the psychological flexibility factor and measures momentary connectedness to one's values. Participants will be asked to consider their experience the day before when rating their responses, and a sample item is: "I stuck to my deeper priorities in life."
Momentary Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA)	Daily during 28 days of mobile prototype app intervention]	The "Lack of Contact With Values" subscale of the MPFI-4 adapted for EMA falls under the psychological inflexibility factor and measures the extent to which one is not connected to their values at the moment. Participants will be asked to consider their experience the day before when rating their responses, and a sample item is: "My priorities and values often fell by the wayside."
Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24)	Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)	A self-report scale that measures psychological flexibility and psychological inflexibility. The scale consists of 24 items, and participants are asked to consider the past two weeks and select a response from a scale ranging from "Never True" to "ALWAYS True". A global score on psychological flexibility and inflexibility is produced, in addition to subscale scores pertaining to each of the six dimensions of psychological flexibility and inflexibility. Scores range from a minimum of 1.0 to 6.0, with higher scores reflecting higher levels of the domain being assessed (i.e., psychological flexibility or inflexibility, etc.).
Random responding question	Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)	Participants will be asked to choose one of the following statements that best describe their participation in the survey, noting that their answer does not impact their participation in the study in any way: "I answered every question carefully and honestly" (1); "I answered most questions carefully and honestly" (2); "I randomly responded and/or did not respond honestly to about half of the questions" (3); "I randomly responded and/or did not respond honestly to most questions" (4); and "I randomly responded and/or did not respond honestly to any questions" (5). Participants who score a 4 or 5 will be screened out for random responding.
System Usability Scale (SUS)	Posttreatment (4 weeks after baseline)	A self-report measure of usability of a technological system. The SUS consists of 10 items rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and doubled such that they range from 0 to 100 (as per the official scoring instructions), with high scores indicating greater usability.
Current Motivation to Exercise	Daily during 28 days of mobile prototype app intervention	Participants will be asked about their current motivation level to exercise. The question is: "How motivated are you right now to exercise?" The rating scale provided ranges from 1 (not at all) to 7 (extremely). This question will be asked both before and after the writing exercise.
Exercise ecological momentary assessment (EMA) questions	Daily during 28 days of mobile prototype app intervention	Participants are asked to respond to questions used in previous research that assess the time spent in the past 24 hours (in minutes) in moderate-intensity physical activity and vigorous-intensity physical activity, in addition to time spent (in hours) on sedentary time. Response options were modified to allow participant to enter minutes rather than selecting a category. The three questions assessing sedentary time asked about how many hours were spent watching television, using the computer, and sitting. The investigators included an additional question assessing light-intensity physical activity.
Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA)	Daily during 28 days of mobile prototype app intervention]	The MPFI-24 was adapted for ecological momentary assessment (EMA) purposes, making it a self-report scale that assesses momentary psychological flexibility and inflexibility. Participants are asked to consider their day yesterday and rate their responses on a scale ranging from "NEVER True" to "ALWAYS True". Scores range from a minimum of 1.0 to 6.0, with higher scores reflecting higher levels of the domain being assessed (i.e., momentary psychological flexibility or inflexibility, etc.).

Trial Locations

Locations (1)

Mindfulness and Acceptance Processes Lab; 🇺🇸 Starkville, Mississippi, United States