Promoting Healthy Exercise to Conscientious Christians

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sedentary Behavior
• Intervention / Treatment: Behavioral: Online 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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul G Ritvo, PhD; Phone Number: 14165808021; Email: pritvo@yorku.ca
• Study Contact Backup: Name: Paul G Ritvo, PhD; Phone Number: 4165808021; Email: pritvo@yorku.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4E 3C1
      • York University - School of Kinesiology and Health Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Sixteen weeks of phone-based counselling at a rate of 1 session/week and ongoing access to a online platform (Nex J Connected Wellness) that has health promotion text and videos readily accessed in combination with text messaging exchanges between counselor and participant. Participants receive a Fitbit which is connected to the Nex J Connected Wellness such that counselors can monitor steps/day.	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)
No Intervention: Wait list control; Participants wait for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Physical Activity Questionnaire (IPAQ) (low-moderate-high)	Self report of physical activity reflecting current activity	Baseline
International Physical Activity Questionnaire (IPAQ) (low-moderate-high)	Change in self report of physical activity	8 weeks
International Physical Activity Questionnaire (IPAQ) (low-moderate-high)	Change in self report of physical activity	16 weeks
Fitbit Versa 2 Fitness Tracker connected to the NexJ Connected Wellness platform.	Electronic monitoring of steps	8 weeks
Fitbit Versa 2 Fitness Tracker connected to the NexJ Connected Wellness platform.	Change in Electronic monitoring of steps	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	Weight and height measurements	Baseline
Body Mass Index (BMI)	Change in Weight and height measurements	16 weeks
Patient Health Questionnaire-9 (PHQ - 9) (0-27)	Brief Measure of Depression	Baseline
Patient Health Questionnaire-9 (PHQ - 9) (0-27)	Change in Brief Measure of Depression	16 weeks
General Anxiety Disorder-7 (GAD-7) (0-21)	Brief measure of Anxiety	Baseline
General Anxiety Disorder-7 (GAD-7) (0-21)	Change in Brief measure of Anxiety	8 weeks
General Anxiety Disorder-7 (GAD-7) (0-21)	Change in Brief measure of Anxiety	16 weeks
Duke University Religion Index (DUREL) (5-27)	Religious committment	Baseline
Duke University Religion Index (DUREL) (5-27) Duke University Religion Index	Change in Duke University Religion Index	8 weeks
Duke University Religion Index (DUREL) (5-27) Duke University Religion Index (5-27)	Change in Duke University Religon Index	16 weeks
Quality of life (EQ-5D) (0-100)	Utility-based measure	Baseline
Quality of life (EQ-5D) (0-100)	Change in Quality of life (EQ-5D)	8 weeks
Quality of life (EQ-5D) (0-100)	Change in Quality of life (EQ-5D)	16 weeks
12 item Grit Scale (12-60)	Measure of 'grit' - long term passionate committment	Baseline
12 item Grit Scale (12-60)	Change in 12 item Grit Scale	8 weeks
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

Collaborators and Investigators

• Sponsor: York University

Study record dates

Study Major Dates

• Study Start (Estimated): November 25, 2023
• Primary Completion (Estimated): November 10, 2025
• Study Completion (Estimated): December 9, 2025

Study Registration Dates

• First Submitted: July 9, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: internet-based intervention with health coaching
• Other Study ID Numbers: 3835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Posting on website
• IPD Sharing Time Frame: 2023-2025 - 2 years
• IPD Sharing Access Criteria: all interested investigators
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No