Clinical trial NCT06119334: Promoting Healthy Exercise to Conscientious Christians
Official title: Promoting Healthy Exercise to Conscientious Christians
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sedentary Behavior
Keywords: internet-based intervention with health coaching;
Lead sponsor: York University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Paralell group design with intervention participants compared to wait-list control subjects. 16 weeks intervention.
Primary purpose: TREATMENT

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.

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: 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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Primary outcomes:
measure: International Physical Activity Questionnaire (IPAQ) (low-moderate-high)
timeFrame: Baseline
measure: International Physical Activity Questionnaire (IPAQ) (low-moderate-high)
timeFrame: 8 weeks
measure: International Physical Activity Questionnaire (IPAQ) (low-moderate-high)
timeFrame: 16 weeks
measure: Fitbit Versa 2 Fitness Tracker connected to the NexJ Connected Wellness platform.
timeFrame: 8 weeks
measure: Fitbit Versa 2 Fitness Tracker connected to the NexJ Connected Wellness platform.
timeFrame: 16 weeks
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: 16 weeks
measure: Patient Health Questionnaire-9 (PHQ - 9) (0-27)
timeFrame: Baseline
measure: Patient Health Questionnaire-9 (PHQ - 9) (0-27)
timeFrame: 16 weeks
measure: General Anxiety Disorder-7 (GAD-7) (0-21)
timeFrame: Baseline
measure: General Anxiety Disorder-7 (GAD-7) (0-21)
timeFrame: 8 weeks
measure: General Anxiety Disorder-7 (GAD-7) (0-21)
timeFrame: 16 weeks
measure: Duke University Religion Index (DUREL) (5-27)
timeFrame: Baseline
measure: Duke University Religion Index (DUREL) (5-27) Duke University Religion Index
timeFrame: 8 weeks
measure: Duke University Religion Index (DUREL) (5-27) Duke University Religion Index (5-27)
timeFrame: 16 weeks
measure: Quality of life (EQ-5D) (0-100)
timeFrame: Baseline
measure: Quality of life (EQ-5D) (0-100)
timeFrame: 8 weeks
measure: Quality of life (EQ-5D) (0-100)
timeFrame: 16 weeks
measure: 12 item Grit Scale (12-60)
timeFrame: Baseline
measure: 12 item Grit Scale (12-60)
timeFrame: 8 weeks
measure: 12 item Grit Scale (12-60)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: York University - School of Kinesiology and Health Science
state: Ontario
Study officials:
References: