Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06119334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-07-09
Brief Title:
Promoting Healthy Exercise to Conscientious Christians
Sponsor:
York University
Organization:
York University
Study Overview
Official Title:
Promoting Healthy Exercise to Conscientious Christians
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 nd 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 99 for cardiovascular diseases 65 for stroke 22 for hypertension and 59 for Type 2 diabetes Increased incidences were also associated with cancer-related diseases 29 for bladder cancer 36 for breast cancer and 39 for colon cancer Katzmarzyk et al 2022 The estimated healthcare costs attributable to PI in Canada were 21 billion 1999 and 24 billion 2009 the latter figure associated with indirect costs of 43 billion and total costs of 68 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 nd 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 99 for cardiovascular diseases 65 for stroke 22 for hypertension and 59 for Type 2 diabetes Increased incidences were also associated with cancer-related diseases 29 for bladder cancer 36 for breast cancer and 39 for colon cancer Katzmarzyk et al 2022 The estimated healthcare costs attributable to PI in Canada were 21 billion 1999 and 24 billion 2009 the latter figure associated with indirect costs of 43 billion and total costs of 68 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 andor adherence to the online Christian-based PA intervention ie 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 ie 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
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 nd 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 99 for cardiovascular diseases 65 for stroke 22 for hypertension and 59 for Type 2 diabetes Increased incidences were also associated with cancer-related diseases 29 for bladder cancer 36 for breast cancer and 39 for colon cancer Katzmarzyk et al 2022 The estimated healthcare costs attributable to PI in Canada were 21 billion 1999 and 24 billion 2009 the latter figure associated with indirect costs of 43 billion and total costs of 68 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 andor adherence to the online Christian-based PA intervention ie 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None