Promoting Healthy Exercise to Conscientious Christians

Sedentary Behavior Clinical Trial

Official title:

Promoting Healthy Exercise to Conscientious Christians

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06119334
• Other study ID #: 3835
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 25, 2023
• Est. completion date: December 9, 2025

Study information

• Verified date: October 2023
• Source: York University
• Contact: Paul G Ritvo, PhD
• Phone: 14165808021
• Email: pritvo[@]yorku.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 9, 2025
• Est. primary completion date: November 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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: 1) 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.

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Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

Behavioral:
• Online intervention
Phone counselling for 1 hour/week over 16 weeks and access to the online platform with health promotion materials (videos, text, audios)

Locations

Country	Name	City	State
Canada	York University - School of Kinesiology and Health Science	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
York University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Physical Activity Questionnaire (IPAQ) (low-moderate-high)	Self report of physical activity reflecting current activity	Baseline
Primary	International Physical Activity Questionnaire (IPAQ) (low-moderate-high)	Change in self report of physical activity	8 weeks
Primary	International Physical Activity Questionnaire (IPAQ) (low-moderate-high)	Change in self report of physical activity	16 weeks
Primary	Fitbit Versa 2 Fitness Tracker connected to the NexJ Connected Wellness platform.	Electronic monitoring of steps	8 weeks
Primary	Fitbit Versa 2 Fitness Tracker connected to the NexJ Connected Wellness platform.	Change in Electronic monitoring of steps	16 weeks
Secondary	Body Mass Index (BMI)	Weight and height measurements	Baseline
Secondary	Body Mass Index (BMI)	Change in Weight and height measurements	16 weeks
Secondary	Patient Health Questionnaire-9 (PHQ - 9) (0-27)	Brief Measure of Depression	Baseline
Secondary	Patient Health Questionnaire-9 (PHQ - 9) (0-27)	Change in Brief Measure of Depression	16 weeks
Secondary	General Anxiety Disorder-7 (GAD-7) (0-21)	Brief measure of Anxiety	Baseline
Secondary	General Anxiety Disorder-7 (GAD-7) (0-21)	Change in Brief measure of Anxiety	8 weeks
Secondary	General Anxiety Disorder-7 (GAD-7) (0-21)	Change in Brief measure of Anxiety	16 weeks
Secondary	Duke University Religion Index (DUREL) (5-27)	Religious committment	Baseline
Secondary	Duke University Religion Index (DUREL) (5-27) Duke University Religion Index	Change in Duke University Religion Index	8 weeks
Secondary	Duke University Religion Index (DUREL) (5-27) Duke University Religion Index (5-27)	Change in Duke University Religon Index	16 weeks
Secondary	Quality of life (EQ-5D) (0-100)	Utility-based measure	Baseline
Secondary	Quality of life (EQ-5D) (0-100)	Change in Quality of life (EQ-5D)	8 weeks
Secondary	Quality of life (EQ-5D) (0-100)	Change in Quality of life (EQ-5D)	16 weeks
Secondary	12 item Grit Scale (12-60)	Measure of 'grit' - long term passionate committment	Baseline
Secondary	12 item Grit Scale (12-60)	Change in 12 item Grit Scale	8 weeks
Secondary	12 item Grit Scale (12-60)	Change in 12 item Grit Scale; Change in; Change in Measure of 'grit' - long term passionate committment	16 weeks