Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2025-12-17 @ 6:17 AM
Study NCT ID:
NCT05661799
Status:
None
Last Update Posted:
2022-12-22 00:00:00
First Post:
2022-11-09 00:00:00
Brief Title:
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
Sponsor:
Siel Bleu
Organization:
Siel Bleu
Study Overview
Official Title:
Psychological Levers of Commitment and Persistence in Physical Activity in People With Type 2 Diabetes. PerPA2Temps Study
Status:
None
Status Verified Date:
2022-12
Last Known Status:
ACTIVE_NOT_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:
PerPA2Temps
Brief Summary:
Type 2 diabetes is one of the chronic pathologies that can be treated, in part or in full, by respecting hygienic-dietary rules (i.e. recommendations on dietary balance and physical activity). Numerous studies have demonstrated the benefits of physical activity (Duclos et al., 2012; Sigal et al., 2013) but few patients change their behaviour over the long term. A field of psychology has put forward certain notions that can be levers for practice: the theory of hope, the feeling of personal efficacy (SEP), motivation and basic psychological needs. Some motivational programmes for physical activity (PA) have been developed on the basis of these concepts in different fields (i.e. work, school) but, to our knowledge, in France, none has yet been developed in the field of health and a fortiori in the management of people with diabetes.
The main objective of this study is to develop and implement an innovative motivational intervention programme in adapted physical activity (APA) for type 2 diabetic patients (T2DM). The aim of this programme is to enable them to improve their chances of engagement and persistence in physical activity. To this end, the investigators would like to study the effect of this type of programme on physical activity.
Secondly, the investigators would like to study, on the one hand, the evolution and the interactions between the different psychological variables in the framework of this innovative intervention programme. On the other hand, the investigators want to study the impact of the intervention on physical fitness, commitment and satisfaction with physical activity.
The study will be set up within the framework of the APA sessions provided by the Siel Bleu association. The subjects will be new exercisers, type 2 diabetics not treated with insulin, having been included through the various partners of Siel Bleu.
the investigators will have an intervention group and a control group. The control group will benefit from a standard APA programme offered by Siel Bleu. A standard APA programme consists of one-hour sessions in a group of up to 15 people. The objective of these Siel Bleu programmes is to maintain or improve the physical capacities of the participants. To achieve this, several session themes are addressed (i.e. endurance, muscular strength of upper and lower limbs, balance, flexibility, coordination). The intervention group will participate in this APA programme with an information and experience sharing session as well as APA challenges and various positive reinforcement exercises. Data will be collected in the form of questionnaires at inclusion, at the end of the programme and at 3, 6 and 12 months after the programme.
For this study, with a risk α=5%, a guaranteed power of 80%, a delta of 25% and a standard deviation of 22.5 minutes, the investigators will need 298 subjects equally distributed in the two groups.
Our primary endpoint will be the amount of physical activity. This will be measured by the Global Physical Activity Questionnaire (GPAQ), which will allow us to differentiate between the various intensities of physical activity and the contexts in which it is performed.
Thanks to our innovative physical activity programme combining weekly PA practice with PA challenges and positive reinforcement exercises, the investigators expect an increase in the amount of physical activity, 12 months after the programme, twice as high as in the control group. We also expect to see changes in feelings of self-efficacy (SEP) and levels of trait and state hope as well as more self-determined motivation.
The investigators also hope that the results will allow us to determine the statistical power of the correlations between the variables as well as to identify typical profiles to predict the evolution of the amount of physical activity.
The main objective of this study is to develop and implement an innovative motivational intervention programme in adapted physical activity (APA) for type 2 diabetic patients (T2DM). The aim of this programme is to enable them to improve their chances of engagement and persistence in physical activity. To this end, the investigators would like to study the effect of this type of programme on physical activity.
Secondly, the investigators would like to study, on the one hand, the evolution and the interactions between the different psychological variables in the framework of this innovative intervention programme. On the other hand, the investigators want to study the impact of the intervention on physical fitness, commitment and satisfaction with physical activity.
The study will be set up within the framework of the APA sessions provided by the Siel Bleu association. The subjects will be new exercisers, type 2 diabetics not treated with insulin, having been included through the various partners of Siel Bleu.
the investigators will have an intervention group and a control group. The control group will benefit from a standard APA programme offered by Siel Bleu. A standard APA programme consists of one-hour sessions in a group of up to 15 people. The objective of these Siel Bleu programmes is to maintain or improve the physical capacities of the participants. To achieve this, several session themes are addressed (i.e. endurance, muscular strength of upper and lower limbs, balance, flexibility, coordination). The intervention group will participate in this APA programme with an information and experience sharing session as well as APA challenges and various positive reinforcement exercises. Data will be collected in the form of questionnaires at inclusion, at the end of the programme and at 3, 6 and 12 months after the programme.
For this study, with a risk α=5%, a guaranteed power of 80%, a delta of 25% and a standard deviation of 22.5 minutes, the investigators will need 298 subjects equally distributed in the two groups.
Our primary endpoint will be the amount of physical activity. This will be measured by the Global Physical Activity Questionnaire (GPAQ), which will allow us to differentiate between the various intensities of physical activity and the contexts in which it is performed.
Thanks to our innovative physical activity programme combining weekly PA practice with PA challenges and positive reinforcement exercises, the investigators expect an increase in the amount of physical activity, 12 months after the programme, twice as high as in the control group. We also expect to see changes in feelings of self-efficacy (SEP) and levels of trait and state hope as well as more self-determined motivation.
The investigators also hope that the results will allow us to determine the statistical power of the correlations between the variables as well as to identify typical profiles to predict the evolution of the amount of physical activity.
Detailed Description:
Type 2 diabetes is one of the chronic pathologies that can be treated in part or in full by respecting hygienic-dietary rules ie recommendations on dietary balance and physical activity Numerous studies have demonstrated the benefits of physical activity Duclos et al 2012 Sigal et al 2013 but few patients change their behaviour over the long term A field of psychology has put forward certain notions that can be levers for practice the theory of hope the feeling of personal efficacy SEP motivation and basic psychological needs Some motivational programmes for physical activity PA have been developed on the basis of these concepts in different fields ie work school but to our knowledge in France none has yet been developed in the field of health and a fortiori in the management of people with diabetes
The main objective of this study is to develop and implement an innovative motivational intervention programme in adapted physical activity APA for type 2 diabetic patients T2DM The aim of this programme is to enable them to improve their chances of engagement and persistence in physical activity To this end the investigators would like to study the effect of this type of programme on physical activity
Secondly the investigators would like to study on the one hand the evolution and the interactions between the different psychological variables in the framework of this innovative intervention programme On the other hand the investigators want to study the impact of the intervention on physical fitness commitment and satisfaction with physical activity
The study will be set up within the framework of the APA sessions provided by the Siel Bleu association The subjects will be new exercisers type 2 diabetics not treated with insulin having been included through the various partners of Siel Bleu
the investigators will have an intervention group and a control group The control group will benefit from a standard APA programme offered by Siel Bleu A standard APA programme consists of one-hour sessions in a group of up to 15 people The objective of these Siel Bleu programmes is to maintain or improve the physical capacities of the participants To achieve this several session themes are addressed ie endurance muscular strength of upper and lower limbs balance flexibility coordination The intervention group will participate in this APA programme with an information and experience sharing session as well as APA challenges and various positive reinforcement exercises Data will be collected in the form of questionnaires at inclusion at the end of the programme and at 3 6 and 12 months after the programme
For this study with a risk α5 a guaranteed power of 80 a delta of 25 and a standard deviation of 225 minutes the investigators will need 298 subjects equally distributed in the two groups
Our primary endpoint will be the amount of physical activity This will be measured by the Global Physical Activity Questionnaire GPAQ which will allow us to differentiate between the various intensities of physical activity and the contexts in which it is performed
Thanks to our innovative physical activity programme combining weekly PA practice with PA challenges and positive reinforcement exercises the investigators expect an increase in the amount of physical activity 12 months after the programme twice as high as in the control group We also expect to see changes in feelings of self-efficacy SEP and levels of trait and state hope as well as more self-determined motivation
The investigators also hope that the results will allow us to determine the statistical power of the correlations between the variables as well as to identify typical profiles to predict the evolution of the amount of physical activity
The main objective of this study is to develop and implement an innovative motivational intervention programme in adapted physical activity APA for type 2 diabetic patients T2DM The aim of this programme is to enable them to improve their chances of engagement and persistence in physical activity To this end the investigators would like to study the effect of this type of programme on physical activity
Secondly the investigators would like to study on the one hand the evolution and the interactions between the different psychological variables in the framework of this innovative intervention programme On the other hand the investigators want to study the impact of the intervention on physical fitness commitment and satisfaction with physical activity
The study will be set up within the framework of the APA sessions provided by the Siel Bleu association The subjects will be new exercisers type 2 diabetics not treated with insulin having been included through the various partners of Siel Bleu
the investigators will have an intervention group and a control group The control group will benefit from a standard APA programme offered by Siel Bleu A standard APA programme consists of one-hour sessions in a group of up to 15 people The objective of these Siel Bleu programmes is to maintain or improve the physical capacities of the participants To achieve this several session themes are addressed ie endurance muscular strength of upper and lower limbs balance flexibility coordination The intervention group will participate in this APA programme with an information and experience sharing session as well as APA challenges and various positive reinforcement exercises Data will be collected in the form of questionnaires at inclusion at the end of the programme and at 3 6 and 12 months after the programme
For this study with a risk α5 a guaranteed power of 80 a delta of 25 and a standard deviation of 225 minutes the investigators will need 298 subjects equally distributed in the two groups
Our primary endpoint will be the amount of physical activity This will be measured by the Global Physical Activity Questionnaire GPAQ which will allow us to differentiate between the various intensities of physical activity and the contexts in which it is performed
Thanks to our innovative physical activity programme combining weekly PA practice with PA challenges and positive reinforcement exercises the investigators expect an increase in the amount of physical activity 12 months after the programme twice as high as in the control group We also expect to see changes in feelings of self-efficacy SEP and levels of trait and state hope as well as more self-determined motivation
The investigators also hope that the results will allow us to determine the statistical power of the correlations between the variables as well as to identify typical profiles to predict the evolution of the amount of physical activity
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