Clinical trial NCT05661799: Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
Official title: Psychological Levers of Commitment and Persistence in Physical Activity in People With Type 2 Diabetes. PerPA2Temps Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Physical Activity
Psychological
Lead sponsor: Siel Bleu
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many programmes exist to enable patients to engage in physical activity, but it is clear that the objectives are often not achieved in terms of quality, quantity or intensity of practice. In this study, the aim is to find alternatives, assuming that strengthening patients' self-efficacy, meeting their basic needs and increasing their level of hope will have an impact on their motivation to practice, which in turn will have an impact on their actual practice. The aim is to develop and implement an innovative intervention programme and to identify the interactions between the variables that are assumed to predict engagement in practice.

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 (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.

Eligibility criteria: Inclusion Criteria:

* Subject over 18 years of age
* Subject who has given signed consent to participate in the protocol
* Type 2 diabetic subject not treated with insulin
* Subject participating for the first time in adapted physical activity sessions provided by Siel Bleu
* Subject understanding and reading French

Exclusion Criteria:

* Subjects with major health problems that prevent them from continuing the programme.
* Subjects who have withdrawn their consent.

Primary outcomes:
measure: Change in amount of physical activity assessed by the French Version of GPAQ
timeFrame: Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention
Secondary outcomes:
measure: Change in the subjects' motivational profile towards a more self-determined motivation assessed by the French Version of the Motivation for Physical Activity for Health Scale
timeFrame: Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention
measure: Change in the satisfaction of basic psychological needs assessed by the French Version of The Basic Psychological Needs.
timeFrame: Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention
measure: Change in self-efficacy assessed by the French Version of The Self-Efficacy Questionnaire
timeFrame: Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention
measure: Change of initial state hope level assessed by the French Version of the State Hope Scale
timeFrame: Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention
measure: Change in dispositional hope level assessed by the French Version of the Adult Dispositional Hope Scale
timeFrame: Pre-intervention/immediately after the intervention
measure: Change in dispositional optimism level assessed by the French Version of The Life Orientation Test-Revised
timeFrame: Pre-intervention/immediately after the intervention
measure: Change in physical condition assessed by The 6-Minute Walk Test
timeFrame: Pre-intervention/immediately after the intervention
measure: Subject attendance assessed by an attendance grid
timeFrame: Through intervention completion, that is, 12 weeks
measure: Participant satisfaction assessed by a study-specific questionnaire
timeFrame: Immediately after the intervention
measure: Individual demographic and socio-economic data assessed by a specific form for the study
timeFrame: Pre-intervention
measure: Initial medical data assessed by a specific form for the study
timeFrame: Pre-intervention
measure: Progressive medical data assessed by a specific form for the study
timeFrame: Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention
Other outcomes:
Locations:
city: Angers
country: France
facility: Elise Maudet-Coulomb
state: Maine Et Loire
Study officials:
affiliation: Université de Lorraine, EA 4360 APEMAC, Metz, France
name: Elise Maudet-Coulomb, Ms
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Lorraine, EA 4360 APEMAC, Metz, France
name: Charles Martin-Krumm, PhD
role: STUDY_CHAIR
affiliation: Institut de recherche Siel Bleu, Paris France
name: Jean-Christophe Mino, PhD
role: STUDY_CHAIR
References: