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Sedentary BehaviorNCT06119334

Promoting Healthy Exercise to Conscientious Christians

A study testing Online intervention in people with Sedentary Behavior, run by York University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Sedentary Behavior
What is being tested?
Online intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteCanada
Study dates
25 Nov 2023to 9 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
  • -

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Paul G Ritvo, PhD contact

14165808021

pritvo@yorku.ca

Paul G Ritvo, PhD contact

4165808021

pritvo@yorku.ca

Canada1 site
  • York University - School of Kinesiology and Health Science

    Toronto, Ontario, M4E 3C1

Other trials in Canada

About this study

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.

Read the 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:

  1. 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.
  2. 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).
  3. 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.
  4. 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

  1. 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).
  2. 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).
  3. 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.
  4. 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.
Being tested
Online intervention
Keywords
internet-based intervention with health coaching;
Medical subject headings
Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online interventionBehavioural

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

Study groups in NCT06119334
Study groupRoleWhat they receive
ExperimentalExperimentalSixteen 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.
Receives: Behavioral: Online intervention
Wait list controlNo interventionParticipants wait for 16 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Self report of physical activity reflecting current activity

    Measured: Baseline

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

    Change in self report of physical activity

    Measured: 8 weeks

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

    Change in self report of physical activity

    Measured: 16 weeks

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

    Electronic monitoring of steps

    Measured: 8 weeks

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

    Change in Electronic monitoring of steps

    Measured: 16 weeks

Secondary outcomes (16)
  1. Body Mass Index (BMI)

    Weight and height measurements

    Measured: Baseline

  2. Body Mass Index (BMI)

    Change in Weight and height measurements

    Measured: 16 weeks

  3. Patient Health Questionnaire-9 (PHQ - 9) (0-27)

    Brief Measure of Depression

    Measured: Baseline

  4. Patient Health Questionnaire-9 (PHQ - 9) (0-27)

    Change in Brief Measure of Depression

    Measured: 16 weeks

  5. General Anxiety Disorder-7 (GAD-7) (0-21)

    Brief measure of Anxiety

    Measured: Baseline

  6. General Anxiety Disorder-7 (GAD-7) (0-21)

    Change in Brief measure of Anxiety

    Measured: 8 weeks

  7. General Anxiety Disorder-7 (GAD-7) (0-21)

    Change in Brief measure of Anxiety

    Measured: 16 weeks

  8. Duke University Religion Index (DUREL) (5-27)

    Religious committment

    Measured: Baseline

  9. Duke University Religion Index (DUREL) (5-27) Duke University Religion Index

    Change in Duke University Religion Index

    Measured: 8 weeks

  10. Duke University Religion Index (DUREL) (5-27) Duke University Religion Index (5-27)

    Change in Duke University Religon Index

    Measured: 16 weeks

  11. Quality of life (EQ-5D) (0-100)

    Utility-based measure

    Measured: Baseline

  12. Quality of life (EQ-5D) (0-100)

    Change in Quality of life (EQ-5D)

    Measured: 8 weeks

  13. Quality of life (EQ-5D) (0-100)

    Change in Quality of life (EQ-5D)

    Measured: 16 weeks

  14. 12 item Grit Scale (12-60)

    Measure of 'grit' - long term passionate committment

    Measured: Baseline

  15. 12 item Grit Scale (12-60)

    Change in 12 item Grit Scale

    Measured: 8 weeks

  16. 12 item Grit Scale (12-60)

    Change in 12 item Grit Scale

    Change in

    Change in Measure of 'grit' - long term passionate committment

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start25 Nov 2023 (estimated)
  3. Primary completion10 Nov 2025 (estimated)
  4. Study completion9 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Paralell group design with intervention participants compared to wait-list control subjects. 16 weeks intervention.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06119334
Sponsor's protocol ID
3835
Status last verified
Oct 2023
First submitted
9 Jul 2023
Last updated
7 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Posting on website

Questions about this trial

What is this clinical trial studying?

A study testing Online intervention in people with Sedentary Behavior, run by York University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paul G Ritvo, PhD (14165808021, pritvo@yorku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Physical Activity Questionnaire (IPAQ) (low-moderate-high) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.

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Promoting Healthy Exercise to Conscientious Christians | AzTrials