Persistence of Physical Activity in People With Type 2 Diabetes Over Time.

NCT ID: NCT05661799

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2023-04-30

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.

Conditions

Diabetes Mellitus, Type 2; Physical Activity; Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Intervention Group

The proposed intervention consists of one hour of adapted physical activity per week for 12 weeks, led by a professional. In addition to this intervention, the intervention includes two 15-minute sessions, one before and one after the session. At the end of each session, a PA challenge and a positive reinforcement exercise will be proposed. The participants will have a week to try to achieve these. In addition to these two 15-minute sessions, participants will benefit from a one-and-a-half hour group session for information and experience sharing. The aim of this session is to discuss different topics related to diabetes.

Group Type: EXPERIMENTAL

Intervention Group

Intervention Type: BEHAVIORAL

The programme is a PA programme consisting of one weekly session for 12 weeks. The one hour of PA is supplemented by two 15-minute periods. At the end of each session, a PA challenge and a positive reinforcement exercise are proposed for the coming week. At the beginning of the next session, the facilitator has a dedicated time to give feedback on these challenges (successes and difficulties encountered). At the end of each session, the facilitator explains the theme of the next challenge and exercise. For the challenge, three options are proposed. Each participant chooses the option he/she prefers. Positive reinforcement exercises are also offered in the same way. They aim to strengthen motivation, hope and the sense of self-efficacy (SEP). In addition to these two 15-minute sessions, participants are offered a one-and-a-half hour group session for information and experience sharing. The aim of this session is to discuss different themes.

Control group

The proposed intervention consists of one hour of adapted physical activity per week for 12 weeks, led by a professional.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: BEHAVIORAL

The programme is a PA programme consisting of one weekly session for 12 weeks.

Interventions

Intervention Group

The programme is a PA programme consisting of one weekly session for 12 weeks. The one hour of PA is supplemented by two 15-minute periods. At the end of each session, a PA challenge and a positive reinforcement exercise are proposed for the coming week. At the beginning of the next session, the facilitator has a dedicated time to give feedback on these challenges (successes and difficulties encountered). At the end of each session, the facilitator explains the theme of the next challenge and exercise. For the challenge, three options are proposed. Each participant chooses the option he/she prefers. Positive reinforcement exercises are also offered in the same way. They aim to strengthen motivation, hope and the sense of self-efficacy (SEP). In addition to these two 15-minute sessions, participants are offered a one-and-a-half hour group session for information and experience sharing. The aim of this session is to discuss different themes.

Intervention Type: BEHAVIORAL

Control Group

The programme is a PA programme consisting of one weekly session for 12 weeks.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siel Bleu

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elise Maudet-Coulomb, Ms

Role: PRINCIPAL_INVESTIGATOR

Université de Lorraine, EA 4360 APEMAC, Metz, France

Charles Martin-Krumm, PhD

Role: STUDY_CHAIR

Université de Lorraine, EA 4360 APEMAC, Metz, France

Jean-Christophe Mino, PhD

Role: STUDY_CHAIR

Institut de recherche Siel Bleu, Paris France

Locations

Elise Maudet-Coulomb

Angers, Maine Et Loire, France

Countries

France

Other Identifiers

PerPA2Temps

Identifier Type: -

Identifier Source: org_study_id