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Clinical Trials/NCT06119334
NCT06119334
Not Yet Recruiting
N/A

Promoting Healthy Exercise to Conscientious Christians

York University1 site in 1 country90 target enrollmentNovember 25, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sedentary Behavior
Sponsor
York University
Enrollment
90
Locations
1
Primary Endpoint
Fitbit Versa 2 Fitness Tracker connected to the NexJ Connected Wellness platform.
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Given the importance of reducing mortality-morbidity, more effective Physical Activity (PA) interventions are important, and the recently observed stabilizations of PI levels suggest that novel methods must be explored (Ozemek et al., 2019).

This study aims to provide a select sedentary subpopulation with a customized intervention hypothesized to increase their PA adoption. Novel recruiting methods are used to identify a target subpopulation (based on multiple characteristics) that can be contacted in multiple sections of North America. We will intervene online and rigorously test the theoretical formulations that identify the subpopulation and the customized intervention.

Detailed Description

Physical inactivity (PI) in North America (NA) is associated with high levels of excess morbidity-mortality (Arraiz et al., 1992; Knight, 2012; Villeneuve et al., 1998) with significant decreases in morbidity-mortality predicted with increased physical activity (PA) in recent literature (del Pozo Cruz, et al., 2022; Fogelholm, 2010; Katzmarzyk \& Mason, 2009; Peterson et al., 2014; Warburton \& Bredin, 2017). The lower range of prevalence indicators of PI suggest that 47% of Americans (Centers for Disease Control and Prevention \[CDC\], n.d.) and 51% of Canadians (Statistics Canada, 2021) do not reach the PA guidelines of 150 minutes of moderate-to-vigorous physical activity (MVPA) weekly. The upper end estimates point to approximately 80% of adults being too sedentary to gain health benefits (Piercy et al., 2018). Recent evidence analyzed by the US 2018 Physical Activity Guidelines Advisory Committee (US Department of Health and Human Services \[HHS\], 2018), based on extensive literature review, indicates strong PI associations with increased all-cause mortality. Also noteworthy were specifically increased incidences of: 9.9% for cardiovascular diseases; 6.5% for stroke; 2.2% for hypertension; and 5.9% for Type 2 diabetes. Increased incidences were also associated with cancer-related diseases (2.9% for bladder cancer; 3.6% for breast cancer; and 3.9% for colon cancer) (Katzmarzyk et al., 2022). The estimated healthcare costs attributable to PI in Canada were $2.1 billion (1999) and $2.4 billion (2009), the latter figure associated with indirect costs of $4.3 billion and total costs of $6.8 billion (Katzmarzyk et al., 2000). Given the importance of reducing mortality-morbidity, more effective Physical Activity (PA) interventions are important, and the recently observed stabilizations of PI levels suggest that novel methods must be explored (Ozemek et al., 2019). This study aims to provide a select sedentary subpopulation with a customized intervention hypothesized to increase their PA adoption. Novel recruiting methods are used to identify a target subpopulation (based on multiple characteristics) that can be contacted in multiple sections of North America. We will intervene online and rigorously test the theoretical formulations that identify the subpopulation and the customized intervention. Physical inactivity (PI) in North America (NA) is associated with high levels of excess morbidity-mortality (Arraiz et al., 1992; Knight, 2012; Villeneuve et al., 1998) with significant decreases in morbidity-mortality predicted with increased physical activity (PA) in recent literature (del Pozo Cruz, et al., 2022; Fogelholm, 2010; Katzmarzyk \& Mason, 2009; Peterson et al., 2014; Warburton \& Bredin, 2017). The lower range of prevalence indicators of PI suggest that 47% of Americans (Centers for Disease Control and Prevention \[CDC\], n.d.) and 51% of Canadians (Statistics Canada, 2021) do not reach the PA guidelines of 150 minutes of moderate-to-vigorous physical activity (MVPA) weekly. The upper end estimates point to approximately 80% of adults being too sedentary to gain health benefits (Piercy et al., 2018). Recent evidence analyzed by the US 2018 Physical Activity Guidelines Advisory Committee (US Department of Health and Human Services \[HHS\], 2018), based on extensive literature review, indicates strong PI associations with increased all-cause mortality. Also noteworthy were specifically increased incidences of: 9.9% for cardiovascular diseases; 6.5% for stroke; 2.2% for hypertension; and 5.9% for Type 2 diabetes. Increased incidences were also associated with cancer-related diseases (2.9% for bladder cancer; 3.6% for breast cancer; and 3.9% for colon cancer) (Katzmarzyk et al., 2022). The estimated healthcare costs attributable to PI in Canada were $2.1 billion (1999) and $2.4 billion (2009), the latter figure associated with indirect costs of $4.3 billion and total costs of $6.8 billion (Katzmarzyk et al., 2000). Given the importance of reducing mortality-morbidity, more effective Physical Activity (PA) interventions are important, and the recently observed stabilizations of PI levels suggest that novel methods must be explored (Ozemek et al., 2019). This study aims to provide a select sedentary subpopulation with a customized intervention hypothesized to increase their PA adoption. Novel recruiting methods are used to identify a target subpopulation (based on multiple characteristics) that can be contacted in multiple sections of North America. We will intervene online and rigorously test the theoretical formulations that identify the subpopulation and the customized intervention. Aims and Objectives: A. To estimate the approximate number of North American individuals who visit Christian - oriented online programs and dialogue on these programs about personally meaningful issues. This estimate is relevant to the potential for online PA interventions to reach ample populations and deliver adoption stimulating, reinforcing effects that result in increased MVPA. B. To assess within a randomized controlled trial (RCT) whether an online Christianbased CBT-PA intervention is more effective than a comparison wait list control condition, in terms of increased MVPA as assessed by self-report (IPAQ), Fitbit (online\] tracked steps, and self-reported changes in body mass index (BMI). C. To assess within a RCT whether engagement with and/or adherence to the online Christian-based PA intervention (i.e. online workbooks completed, online text messages exchanged, phone sessions completed) predicts increased MVPA. D. To compare the cost-effectiveness of the online Christian-based PA intervention to the comparison wait-list control condition at post-intervention (4 months) and at 2 months post-follow up (6 months). Hypotheses A. An increasing number of North Americans visit Christian online groups and programs and exchange dialogues on personally meaningful Christianity issues. Amidst the \~231 million Christians estimated to reside in North America, we believe an increasing proportion (30% to 40%) are engaging in online visits per month (Johnson et al., 2018). B. The Christian-based CBT-PA intervention is more effective than the comparison (wait list control) condition in terms of significantly increased MVPA as assessed by self-report (IPAQ), Fitbit (online) tracked steps, and self-reported changes in body mass index (BMI). C. Engagement in and adherence to the online Christian-based PA intervention (i.e. online workbooks completed, online text messages exchanged, phone sessions completed) will predict significantly increased MVPA in the experimental group. D. The online Christian-based PA intervention program will be significantly more cost effective when compared to the comparison condition at postintervention and at 2 months follow up.

Registry
clinicaltrials.gov
Start Date
November 25, 2023
End Date
December 9, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul Ritvo

Principal Investigator

York University

Eligibility Criteria

Inclusion Criteria

  • (1) 25 to 55 years old; (2) self-identification as a regular church attendee (Lazerwitz, 1962); (3) willingness to complete the Big Five Inventory (BFI) (John et al., 2008; John \& Srivastava, 1999; (4) BFI scores that are 1 SD \> the mean score typically derived in most published studies; (5) willingness to receive and use a loaned Fitbit Versa 2 delivered by FedEx and commit to wearing it during daytime hours on a daily basis for the duration of the 16 week intervention (6) BMI between 27 and 33; (7) fluent in English; (8) approval from a primary care physician for initiating a graded-incremental walking exercise routine; (9) ability to walk for 30 minutes at a time without significant self-identification of pain and/or orthopedic dysfunction.

Exclusion Criteria

  • Individuals who self-report a past or present diagnosis of Bipolar Disorder, Borderline Personality Disorder, Obsessive-Compulsive Disorder, Schizophrenia, Substance Abuse/Addiction in the past three months will be excluded; suicidal ideation or attempted suicide in the past six months prior to the study are also exclusion factors; (2) individuals with a self-reported co-morbid illness or condition that could be negatively affected by walking exercise; 3) individuals who report walking 20 minutes per day (on average) or more.

Outcomes

Primary Outcomes

Fitbit Versa 2 Fitness Tracker connected to the NexJ Connected Wellness platform.

Time Frame: 16 weeks

Change in Electronic monitoring of steps

International Physical Activity Questionnaire (IPAQ) (low-moderate-high)

Time Frame: 16 weeks

Change in self report of physical activity

Secondary Outcomes

  • Duke University Religion Index (DUREL) (5-27)(Baseline)
  • 12 item Grit Scale (12-60)(16 weeks)
  • Body Mass Index (BMI)(16 weeks)
  • Patient Health Questionnaire-9 (PHQ - 9) (0-27)(16 weeks)
  • General Anxiety Disorder-7 (GAD-7) (0-21)(16 weeks)
  • Duke University Religion Index (DUREL) (5-27) Duke University Religion Index(8 weeks)
  • Duke University Religion Index (DUREL) (5-27) Duke University Religion Index (5-27)(16 weeks)
  • Quality of life (EQ-5D) (0-100)(16 weeks)

Study Sites (1)

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