Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04863235
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-04-23
Brief Title:
Examining the Impact of a Self-compassion Intervention on Physical Activity Behaviour Among People With Prediabetes
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Examining the Impact of a Self-compassion Intervention on Physical Activity Behaviour An Efficacy Trial
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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 investigators plan to examine whether teaching people at risk for type two diabetes to use self-compassion orientation to care for oneself during difficult situations helps them self-manage and increase their physical activity People at risk for type 2 diabetes will learn about their type 2 diabetes risk and strategies to increase their physical activity which represents the recommended information that people at risk for type two diabetes should receive In addition to this some participants but not all will be taught to be self-compassionate in relation to their type two diabetes risk and their efforts to increase their physical activity The investigators expect that people who receive the additional training about how to be self-compassionate will engage in more physical activity than people who do not and they will do so because of self-compassions positive effect on aspects of self-management - adaptive reactions and a tendency to use strong self-management skills This study is important for health promotion because it allows the investigators to determine whether they can improve how they currently help people prevent type 2 diabetes through engaging in physical activity
Detailed Description:
The primary research objective of this efficacy trial is to determine if a self-compassion intervention can lead to a clinically significant increase in engagement in physical activity as compared to usual care best behaviour change practice in individuals with prediabetes
Primary research question Will a self-compassion intervention that augments usual care lead to greater increases in physical activity over 12 weeks post-intervention follow-up than usual care alone among people with prediabetes Primary hypothesis Self-compassion will lead to greater increases in physical activity than usual care at intervention-end and at 6- and 12-weeks
Secondary research question Will the effects of a self-compassion intervention on physical activity at 6- and 12-weeks post intervention be mediated by i negative affect ii physical activity self-regulatory skills and iii personal growth at baseline and intervention-end Secondary hypothesis The effects of self-compassion on physical activity behaviour at 6- and 12-weeks will be mediated by i affect and ii self-regulatory skill use assessed at baseline and intervention-end
Tertiary research question Will a self-compassion intervention that augments usual care lead to greater increases in other health-promoting behaviours eg nutrition stress management seeking medical attention Tertiary hypothesis Self-compassion will lead to greater increases in health-promoting behaviours than usual care at intervention end 6-weeks and 12-weeks post intervention
This efficacy trial is a single centre randomized active controlled eight week intervention with baseline and follow-up assessment at intervention-end 6- and 12-weeks post-intervention It follows a quantitative-dominant mixed-methods design The investigators will compare the change in physical activity of community-dwelling people with prediabetes randomized to usual care in the form of behaviour change attention control condition to that of participants who receive usual care self-compassion training intervention condition The investigators will also examine potential mediators of the intervention ie negative affect physical activity self-regulatory skill use
They will supplement this trial with interviews after follow-up testing with a subsample of self-compassion intervention participants These interviews will provide feasibility information from participants eg receptivity as well as provide a qualitative assessment of the investigators outcome measures
Primary research question Will a self-compassion intervention that augments usual care lead to greater increases in physical activity over 12 weeks post-intervention follow-up than usual care alone among people with prediabetes Primary hypothesis Self-compassion will lead to greater increases in physical activity than usual care at intervention-end and at 6- and 12-weeks
Secondary research question Will the effects of a self-compassion intervention on physical activity at 6- and 12-weeks post intervention be mediated by i negative affect ii physical activity self-regulatory skills and iii personal growth at baseline and intervention-end Secondary hypothesis The effects of self-compassion on physical activity behaviour at 6- and 12-weeks will be mediated by i affect and ii self-regulatory skill use assessed at baseline and intervention-end
Tertiary research question Will a self-compassion intervention that augments usual care lead to greater increases in other health-promoting behaviours eg nutrition stress management seeking medical attention Tertiary hypothesis Self-compassion will lead to greater increases in health-promoting behaviours than usual care at intervention end 6-weeks and 12-weeks post intervention
This efficacy trial is a single centre randomized active controlled eight week intervention with baseline and follow-up assessment at intervention-end 6- and 12-weeks post-intervention It follows a quantitative-dominant mixed-methods design The investigators will compare the change in physical activity of community-dwelling people with prediabetes randomized to usual care in the form of behaviour change attention control condition to that of participants who receive usual care self-compassion training intervention condition The investigators will also examine potential mediators of the intervention ie negative affect physical activity self-regulatory skill use
They will supplement this trial with interviews after follow-up testing with a subsample of self-compassion intervention participants These interviews will provide feasibility information from participants eg receptivity as well as provide a qualitative assessment of the investigators outcome measures
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