Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142688
Status:
COMPLETED
Last Update Posted:
2015-10-29
First Post:
2005-09-01
Brief Title:
Examining Psychosocial Mediators of Exercise Behavior
Sponsor:
HealthPartners Institute
Organization:
HealthPartners Institute
Study Overview
Official Title:
Examining Psychosocial Mediators of Exercise Behavior
Status:
COMPLETED
Status Verified Date:
2015-10
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:
The purpose of this study is to examine psychosocial mediators of exercise behavior
Detailed Description:
BACKGROUND
Physical inactivity is related to many health problems including increased risk of cardiovascular disease hypertension and cancer Despite the health consequences of a sedentary lifestyle only 25 percent of Americans meet the recommended levels of physical activity Researchers postulate that theory-based interventions effectively influence physical activity behavior by changing theoretical constructs believed to be important for behavior change ie potential mediators such as self-efficacy ie confidence in ones ability to be physically active Unfortunately previous studies have generally failed to adequately test the mediating effect of theoretical constructs using appropriate statistical mediator analyses as recommended by leading behavioral scientists and statisticians
DESIGN NARRATIVE
The study will examine the mediating effect of theoretical constructs based on the Transtheoretical Model TTM and Social Cognitive Theory SCT The study will address the methodological measurement and statistical limitations of previous studies The investigators will randomly assign 420 healthy sedentary individuals to either a theory-based physical activity intervention or a contact control group Physical activity behavior and the potential mediators will be assessed monthly over 12 months They hypothesize that constructs based on the TTM and SCT ie behavioral processes cognitive processes self-efficacy and decisional balance will mediate the relationship between group assignment intervention vs contact control and physical activity behavior such that the effect of the intervention on physical activity behavior relative to the contact control group will be attenuated when controlling for the mediators They will also examine the importance of particular mediators for different population groups eg age gender which will help to create more effective interventions for these groups Finally they will conduct a cost analysis to not only inform policy makers of the cost of delivering the intervention within our study but also to estimate the cost of delivering each component of the intervention ie mediator The analysis will estimate the cost of future refined interventions that incorporate those active components that affect the mediators and physical activity in this study In summary the study will identify which mediators ie theoretical constructs are most effective for increasing physical activity which will have an important public health impact given that this will likely lead to more efficacious and less costly interventions
Physical inactivity is related to many health problems including increased risk of cardiovascular disease hypertension and cancer Despite the health consequences of a sedentary lifestyle only 25 percent of Americans meet the recommended levels of physical activity Researchers postulate that theory-based interventions effectively influence physical activity behavior by changing theoretical constructs believed to be important for behavior change ie potential mediators such as self-efficacy ie confidence in ones ability to be physically active Unfortunately previous studies have generally failed to adequately test the mediating effect of theoretical constructs using appropriate statistical mediator analyses as recommended by leading behavioral scientists and statisticians
DESIGN NARRATIVE
The study will examine the mediating effect of theoretical constructs based on the Transtheoretical Model TTM and Social Cognitive Theory SCT The study will address the methodological measurement and statistical limitations of previous studies The investigators will randomly assign 420 healthy sedentary individuals to either a theory-based physical activity intervention or a contact control group Physical activity behavior and the potential mediators will be assessed monthly over 12 months They hypothesize that constructs based on the TTM and SCT ie behavioral processes cognitive processes self-efficacy and decisional balance will mediate the relationship between group assignment intervention vs contact control and physical activity behavior such that the effect of the intervention on physical activity behavior relative to the contact control group will be attenuated when controlling for the mediators They will also examine the importance of particular mediators for different population groups eg age gender which will help to create more effective interventions for these groups Finally they will conduct a cost analysis to not only inform policy makers of the cost of delivering the intervention within our study but also to estimate the cost of delivering each component of the intervention ie mediator The analysis will estimate the cost of future refined interventions that incorporate those active components that affect the mediators and physical activity in this study In summary the study will identify which mediators ie theoretical constructs are most effective for increasing physical activity which will have an important public health impact given that this will likely lead to more efficacious and less costly interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A04-102 | OTHER | HealthPartners Institute | httpsreporternihgovquickSearchR01HL072947 |
| R01HL072947 | NIH | None | None |