Clinical trial NCT06372275: Investigating Two Prototype Mobile App Interventions to Increase Physical Activity
Official title: Reframing Health Behavior Change: A Randomized Controlled Trial of a Relational Frame Theory (RFT)-Informed Values Intervention for Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health-Related Behavior
Keywords: Physical Activity
Exercise
Values Clarification
Self-Reflection
Acceptance and Commitment Therapy
Mobile App
Motivation
Lead sponsor: Mississippi State University
Sponsor class: OTHER
Collaborators: name: Association for contextual behavioral science
First posted: 2024-04-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: International Physical Activity Questionnaire (IPAQ) - Total physical activity
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
Secondary outcomes:
measure: Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Total score
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Amotivation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: External Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Introjected Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Identified Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Integrated Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Intrinsic Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire v1.2
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Global Mental Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Global Physical Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Satisfaction with Social Roles and Activities 8a
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Values Clarity Questionnaire (VCQ)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Self-Compassion Scale Short Form (SCS-SF)
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Random responding question
timeFrame: Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline)
measure: Credibility & Expectancy Questionnaire (CEQ)
timeFrame: After the app tutorial (approximately 0-1 weeks after baseline)
measure: System Usability Scale (SUS)
timeFrame: Posttreatment (4 weeks after baseline)
measure: Treatment Evaluation Inventory-Short Form (TEI-SF)
timeFrame: Posttreatment (4 weeks after baseline)
measure: Exercise ecological momentary assessment (EMA) questions
timeFrame: Daily during 28 days of mobile prototype app intervention
measure: Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA)
timeFrame: Daily during 28 days of mobile prototype app intervention]
measure: 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)
timeFrame: Daily during 28 days of mobile prototype app intervention]
measure: 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)
timeFrame: Daily during 28 days of mobile prototype app intervention]
measure: Emotion ratings
timeFrame: Daily during 28 days of mobile prototype app intervention
measure: Current Motivation to Exercise
timeFrame: Daily during 28 days of mobile prototype app intervention
measure: Previous Day Stress Level
timeFrame: Daily during 28 days of mobile prototype app intervention
Other outcomes:
Locations:
city: Starkville
country: United States
facility: Mindfulness and Acceptance Processes Lab
state: Mississippi
Study officials:
affiliation: Mississippi State University
name: Jennifer Krafft, PhD
role: PRINCIPAL_INVESTIGATOR
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