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Clinical Trial Summary

Physical activity (PA) has been suggested to lower one's risk of developing cancer, type 2 diabetes, and cardiovascular disease. While there are benefits from engaging in PA, many people do not engage in enough daily PA, thus increasing the chance of developing non-communicable diseases (NCD). Some NCDs, such as type 2 diabetes, have been shown to occur at higher rates within under-resourced populations, such as low socioeconomic status (SES) communities. Among low-SES communities, external barriers, such as cost and the surrounding physical environment, have been shown to impact engagement in PA. A multi-level PA intervention could be beneficial to help lower NCD health outcomes within at-risk groups, as well as serve as a means to further understand the barriers impeding a healthy lifestyle. At the individual level, past behavior is suggested to be a significant predictor of future behavior. When faced with a NCD diagnosis, one might think about the past and how things could have turned out differently (i.e., counterfactual thinking). For instance, what if a different action had been taken (e.g., "If only I had taken the stairs more at work")? Counterfactuals can also serve as a way of identifying causal links (e.g., "If only there were more green spaces in my area..."). Counterfactuals (CF) on behaviors that can be acted on can facilitate future behavior change by increasing intentions, motivation, and self-efficacy. In this way, CFs might help with 1) breaking a habitual sedentary cycle and 2) identify causal pathways of barriers impacting PA engagement. While preliminary data in the investigators lab suggests that CF strategies are relevant for heightening contemplation to change behaviors and intentions to change behaviors its impact on motivation and self-efficacy remains unknown. Additionally, these preliminary studies were conducted using small, undergraduate student sample, thus generalizability to low-SES individuals living in the surrounding community is unknown. For the proposed study, participants will use CFs to target barriers in different domains and levels of influence impeding PA. This identification effort will be used to work towards increasing PA behavior (collected by wearable fitness trackers). CFs will also be used to work towards increasing psychological domains relevant to behavior change over the span of 14 weeks.


Clinical Trial Description

A.1 Significance A.1.1 Physical Activity. The CDC suggests that 150-300 minutes of moderate-intensity physical activity (PA) is important to staving off non-communicable diseases (NCD) such as cancer, type 2 diabetes, and comorbidity health outcomes. However, many communities, such as low-socioeconomic (SES) communities, are not engaging in enough regular PA to reap the benefits, such as decreased chance in experiencing NCD health outcomes. Results from qualitative studies often relay common barriers and themes impeding PA requirements, such as environmental factors and resource availability. Limitations of physical activity interventions. Common PA interventions largely do not incorporate a multi-level framework to acknowledge external barriers. Focusing on individual-level factors, such as self-efficacy, are small parts of why an individual may or may not engage in PA; casting a wider net to capture an array of barriers would provide better understanding of current inactivity trends. Qualitative studies that inquire about multi-level external barriers typically do not juxtapose the current state of barriers (the facts) with the ideal outcome if the barriers were removed (counterfactuals, e.g., "If only…"). Researchers are missing out on a way to align potential solutions with how community members frame their understanding of their environment and their ability to act in that environment. A.1.2 Counterfactuals, Causality, and Goal-Pursuit Theory. An individual might reflect on their past to help inform the present. For instance, thinking "If I had taken a walk during my lunch break, then I would have met my step goal." Known as counterfactual thinking (CF), these thoughts can help us understand how elements within one's environment might be causally connected (i.e., If…then…). According to functional CF theory, CFs describing a better outcome via a self-focused action can lead to heightened goal-pursuit behaviors. The efficacy of CF strategies in a longitudinal PA study has yet to be established. A.1.3 Multilevel Determinants of Health Disparities. There has been a call for researchers to look beyond individual-level factors impacting PA. One way to answer this call is to use multi-level frameworks, such as the NIMHD research framework, for understanding the ways in which health is impacted within and between different internal and external agents. The NIMHD framework outlines levels of influence (individual, interpersonal, community, and societal) and domains of influence (biological, behavioral, physical/built environment, sociocultural environment, and health care system) that can be used to conceptualize and understand minoritized health outcomes. This allows for a nuanced understanding of factors driving health outcome inequity. B.1 Innovation and Relation to PATHS-UP ERC This proposal seeks to uniquely address a multi-level need by, 1) inviting the individual to provide a detailed look at various PA barriers participants experience in day-to-day life, 2) highlighting how certain pathways are framed as causally connected to themselves and their community, and 3) providing a relevant antecedent steppingstone to how these barriers could be minimized, altered, or removed altogether. Aligning with PATHS-UP ERC's commitment towards addressing health inequity and health-promotion access and participation, the proposed study will focus on addressing health barriers in underserved communities. C.1 Specific Aims C.1.1 Specific Aims 1: Identify barriers to PA experienced by low-SES individuals. Participants will engage in a semi-structured interview with a trained researcher on the experiment day. During this time, participants will be randomly assigned to either the CF strategy or the control condition. Both conditions will be asked to identify, using the NIMHD Research Framework, any barriers towards engaging in PA. Hypothesis 1: Participants will identify more externally focused, compared to internally focused, barriers that then impact them at the individual and behavioral level. C.1.2 Specific Aim 2: Determine the effect of a CF strategies on PA behavior. Participants in both conditions will complete demographics and psychological measures of contemplation to change PA engagement, motivation, self-efficacy, and intention to engage in PA at baseline, experiment day, and follow-up visits. Participants will be given a Fitbit to wear for 14 weeks to record step count, heartrate, and additional exercise data. Hypothesis 1: Compared to the control, the CF strategy condition will report higher levels of contemplation to change, motivation, self-efficacy, and intentions to engage in PA. Hypothesis 2: The CF strategy condition will report greater increases in PA correlates over the 14-week period compared to the control condition. D.1 Approach D.1.1 Baseline Session (week 1). Participants will go over informed consent with a researcher and then fill out a measure of demographics. The researcher will walk the participant through creating a Fitbit profile and input demographic info (age, gender, height, weight). Participants will receive a Fitbit to collect PA data, a charger, and download the Fitbit phone app to sync their data. Participants will be asked to wear the Fitbit during the hours that the participants are awake and throughout the time the participants are asleep. Participants will complete PA psychological measures of contemplation to change, self-efficacy, motivation, and intentions. D.1.2 Experiment Day (week 2). Participants will undergo a semi-structured interview. The interview audio will be recorded and transcribed via Zoom. Participants will first be asked to describe past events where the participant were unable to participate or engage in PA. After describing the event(s), participants will be randomly assigned to one of two conditions, the CF strategy or control. All participants will walk through the NIMHD framework with a researcher and be guided to identify barriers at various domains and levels of influence, which impacted their events the participant just described. A printout of the NIMHD framework with examples will be provided to the participant. CF Strategy: Participants will engage in CFs on barriers the participant believes the participant could have reasonably acted on to increase PA in their described event(s) that would have led to a better outcome. The researcher will write these down as the participants speaks so what is listed can be easily referred to for the next step. After identifying the CFs, participants will then select three CFs the participant just identified that the participant could use at some point in the upcoming week. Participants will identify a time in the upcoming week to engage in the CF, any obstacles to using that CF, ways to overcome those obstacles, their intention to use the CF over the next week, and how likely the participant think the CF would have happened and led to the better outcome. Participants will then fill out the PA psychological measures. Control: After barrier identification, participants will be asked to select three barriers to talk aloud and list out additional details about the barriers identified. Participants will then fill out the PA psychological measures. D.1.3 Weekly Follow-Up Sessions (weeks 3-13). Weeks 3-13 are spaced one week apart. Participants will be emailed a weekly survey to fill out PA psychological measures and complete condition specific measures. CF strategy participants will be presented with their selected CFs from the previous week and indicate CF engagement over the past week. Participants will also be given a chance to write about new PA events that occurred over the previous week and barriers; CF strategy participants will generate CFs on the controllable barriers, while the control participants will list details. CF strategy participants can use the same three CFs for the upcoming week or swap them for new or more relevant CFs; the participant will then indicate intentions to use them for the upcoming week and the likelihood that the CFs would have actually happened and led to change. Control participants will only be asked to list details about any new events and barriers. D.1.4 Conclusion (week 14). All participants will return to the lab to return study materials and sync PA data. Participants will complete a final follow up and engage in a brief semi-structured interview on their reception to their PA condition, perceptions of barriers, and future use of CF strategies. Participants will then be thoroughly debriefed on the goals and purpose of the study. E.1 Broader Impacts The proposed study will provide further information on using non-invasive wearable trackers (i.e., Fitbits) and a low-cost, self-identification strategy plan for addressing PA outcomes among underserved communities. Specifically, the qualitative nature of the study design can directly speak towards PATHS-UP mission within Industry and Culture of Inclusion. Speaking directly with underserved community members and understanding everyday barriers towards achieving optimal health and wellness via PA will be invaluable. The investigators will be able to ensure PATHS-UP present and future efforts to address barriers to PA health outcomes aligns with the foci of community members. Lastly, the efforts of this proposal will be used as the foundation for future research grant submission to work towards addressing health outcomes among underserved communities. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05192226
Study type Interventional
Source Texas A&M University
Contact Rachel E Smallman, PhD
Phone 979-845-3983
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 10, 2022
Completion date September 30, 2022

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