NCT05192226

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

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

December 20, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

April 12, 2023

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

December 20, 2021

Last Update Submit

April 11, 2023

Conditions

Keywords

low-socioeconomic statusPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Change in Fitbit Active Zone Minutes

    As per the description by Fitbit, "...earn Active Zone Minutes for time spent in the fat burn, cardio, or peak heart-rate zones. To help you maximize your time, you earn 2 Active Zone Minutes for each minute you're in the cardio or peak zones. Heart-rate zones are personalized based on your fitness level and age." The tracker will record when the participant enters each personalized target heart rate zone. The Fitbit device automatically adds up the Active Zone Minutes per day and per week. The device registers 1 zone minute per minute spent in the Fat Burn zone, and 2 zone minutes per minute spent in Cardio or Peak zones.

    Weekly (14 weeks); collected every day via the Fitbit device for the 14-week duration of the study. Will assess weekly change over the course of the 14 week period.

Secondary Outcomes (4)

  • Contemplation Ladder

    Weekly (14 weeks); occurring once a week for study weeks 1 through 14.

  • Physical Activity Self-Efficacy

    Weekly (14 weeks); occurring once a week for study weeks 1 through 14.

  • Physical Activity Motivation

    Weekly (14 weeks); occurring once a week for study weeks 1 through 14.

  • Physical Activity Intentions

    Weekly (14 weeks); occurring once a week for study weeks 1 through 14.

Study Arms (2)

Counterfactual Strategy Intervention

EXPERIMENTAL

After participants finish describing past events where they were unable to participate or engage in physical activity and have identified barriers which impacted their events they just described, participants will be randomly assigned to conditions. Participants in the counterfactual strategy condition will engage in counterfactual strategies on barriers they believe they could have reasonably acted on to increase physical activity in their described event(s) that would have led to a better outcome. After identifying the counterfactual strategies, participants will then select three counterfactual strategies they just identified that they could use at some point in the upcoming week, any obstacles to using that counterfactual strategy, ways to overcome those obstacles, their intention to use the counterfactual strategy over the next week, and how likely they think the counterfactual strategy would have happened and led to the better outcome.

Behavioral: Counterfactual Strategy

Control

NO INTERVENTION

Participants will be asked to describe past events where they were unable to participate or engage in physical activity. 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 they just described. After barrier identification, participants will be asked to select three barriers to talk aloud and list out additional details about the barriers identified.

Interventions

Participants in this intervention condition will think about their past and identify how a less than desirable physical activity event could have turned out better using counterfactual thinking (i.e., If only I... then....). After identifying actions they could have taken to reach a better outcome in their physical activity event, they will then apply those thoughts to the future upcoming week so they can be realized.

Also known as: Counterfactual thinking, The functional theory of counterfactual thinking
Counterfactual Strategy Intervention

Eligibility Criteria

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

You may qualify if:

  • years old or older
  • access to the internet
  • has a smartphone capable of syncing with a Fitbit Inspire 2 via Bluetooth
  • and must report low SES by indicating a response of 7 or higher on the Subjective SES Ladder

You may not qualify if:

  • Having any physical or cognitive impairment that would impact one's ability to engage in low to moderate levels of exercise
  • Must not currently be participating or plan to participate in similar studies or programs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

Related Publications (19)

  • Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.

    PMID: 11129362BACKGROUND
  • Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360-5. doi: 10.1037//0278-6133.10.5.360.

    PMID: 1935872BACKGROUND
  • Rodgers, W. M., & Sullivan, M. J. L. (2001). Task, coping, and scheduling self-efficacy in relation to frequency of physical activity. Journal of Applied Social Psychology, 31(4), 741-753. https://doi.org/10.1111/j.1559-1816.2001.tb01411.x

    BACKGROUND
  • Fishbein, M., & Ajzen, I. (2010). Predicting and changing behavior: The reasoned action approach. Psychology Press.

    BACKGROUND
  • Attig, C., & Franke, T. (2019). I track, therefore I walk - Exploring the motivational costs of wearing activity trackers in actual users. International Journal of Human-Computer Studies, 127, 211-224.

    BACKGROUND
  • Alvidrez J, Castille D, Laude-Sharp M, Rosario A, Tabor D. The National Institute on Minority Health and Health Disparities Research Framework. Am J Public Health. 2019 Jan;109(S1):S16-S20. doi: 10.2105/AJPH.2018.304883.

    PMID: 30699025BACKGROUND
  • Ozemek C, Lavie CJ, Rognmo O. Global physical activity levels - Need for intervention. Prog Cardiovasc Dis. 2019 Mar-Apr;62(2):102-107. doi: 10.1016/j.pcad.2019.02.004. Epub 2019 Feb 22.

    PMID: 30802461BACKGROUND
  • Zhang H, Rodriguez-Monguio R. Racial disparities in the risk of developing obesity-related diseases: a cross-sectional study. Ethn Dis. 2012 Summer;22(3):308-16.

    PMID: 22870574BACKGROUND
  • Humbert ML, Chad KE, Spink KS, Muhajarine N, Anderson KD, Bruner MW, Girolami TM, Odnokon P, Gryba CR. Factors that influence physical activity participation among high- and low-SES youth. Qual Health Res. 2006 Apr;16(4):467-83. doi: 10.1177/1049732305286051.

    PMID: 16513991BACKGROUND
  • Bantham A, Taverno Ross SE, Sebastiao E, Hall G. Overcoming barriers to physical activity in underserved populations. Prog Cardiovasc Dis. 2021 Jan-Feb;64:64-71. doi: 10.1016/j.pcad.2020.11.002. Epub 2020 Nov 5.

    PMID: 33159937BACKGROUND
  • Wilson DK, Kirtland KA, Ainsworth BE, Addy CL. Socioeconomic status and perceptions of access and safety for physical activity. Ann Behav Med. 2004 Aug;28(1):20-8. doi: 10.1207/s15324796abm2801_4.

    PMID: 15249256BACKGROUND
  • Roese, N. J., & Epstude, K. (2017). The functional theory of counterfactual thinking: New evidence, new challenges, new insights. Advances in Experimental Social Psychology, 56, 1-79.

    BACKGROUND
  • Kriska AM, Saremi A, Hanson RL, Bennett PH, Kobes S, Williams DE, Knowler WC. Physical activity, obesity, and the incidence of type 2 diabetes in a high-risk population. Am J Epidemiol. 2003 Oct 1;158(7):669-75. doi: 10.1093/aje/kwg191.

    PMID: 14507603BACKGROUND
  • Friedenreich CM, Ryder-Burbidge C, McNeil J. Physical activity, obesity and sedentary behavior in cancer etiology: epidemiologic evidence and biologic mechanisms. Mol Oncol. 2021 Mar;15(3):790-800. doi: 10.1002/1878-0261.12772. Epub 2020 Aug 18.

    PMID: 32741068BACKGROUND
  • Byrne RM. Counterfactual Thought. Annu Rev Psychol. 2016;67:135-57. doi: 10.1146/annurev-psych-122414-033249. Epub 2015 Sep 14.

    PMID: 26393873BACKGROUND
  • Spellman, B. A. & Mandel, D. R. (1999). When possibility informs reality: Counterfactual thinking as a cue to causality. Current Directions in Psychological Science, 8, 120-123.

    BACKGROUND
  • Dyczewski, E. A., & Markman, K. D. (2012).General attainability beliefs moderate the motivational effects of counterfactual thinking. Journal of Experimental Social Psychology, 48, 1217-1220.

    BACKGROUND
  • Epstude K, Roese NJ. The functional theory of counterfactual thinking. Pers Soc Psychol Rev. 2008 May;12(2):168-92. doi: 10.1177/1088868308316091.

    PMID: 18453477BACKGROUND
  • Roese, N. J. (1994). The functional basis of counterfactual thinking. Journal of Personality and Social Psychology, 66, 805-818.

    BACKGROUND

MeSH Terms

Conditions

Financial StressMotor Activity

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Rachel E Smallman, PhD

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 14, 2022

Study Start

March 30, 2022

Primary Completion

December 19, 2022

Study Completion

December 19, 2022

Last Updated

April 12, 2023

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

An outline of the main study hypotheses and statistical analysis plan to analyze the main hypotheses will be provided on the linked OSF page for the study.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
All study materials and protocol will be available upon study completion and completion of initial analysis plan.
Access Criteria
Researchers with a registered OSF account.
More information

Locations