Reframing Health Behavior Change: A Randomized Controlled Trial of a Relational Frame Theory (RFT)-Informed Values Intervention for Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- International Physical Activity Questionnaire (IPAQ) - Total physical activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
International Physical Activity Questionnaire (IPAQ) - Total physical activity
时间窗: 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".
次要结局
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- Values Clarity Questionnaire (VCQ)(Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline))
- Credibility & Expectancy Questionnaire (CEQ)(After the app tutorial (approximately 0-1 weeks after baseline))
- 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))
- 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))
- 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))
- 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))
- Treatment Evaluation Inventory-Short Form (TEI-SF)(Posttreatment (4 weeks after baseline))
- Previous Day Stress Level(Daily during 28 days of mobile prototype app intervention)
- 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))
- Self-Compassion Scale Short Form (SCS-SF)(Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline))
- 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])
- 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])
- Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24)(Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline))
- Random responding question(Baseline, Posttreatment (4 weeks after baseline) and Follow-up (8 weeks after baseline))
- System Usability Scale (SUS)(Posttreatment (4 weeks after baseline))
- Current Motivation to Exercise(Daily during 28 days of mobile prototype app intervention)
- Exercise ecological momentary assessment (EMA) questions(Daily during 28 days of mobile prototype app intervention)
- 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])
- Emotion ratings(Daily during 28 days of mobile prototype app intervention)
研究者
Jennifer Krafft
Assistant Professor
Mississippi State University