Evaluation of the Effectiveness of Extending the "Passerelle" System for Prescribing Adapted Physical Activity to Patients With Type 2 Diabetes in Nouvelle-AQUItaine (France)
NCT Number: NCT06493955
Acronym: PAPA-NAQUI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2
Interventions: OTHER: Adapted physical activity for 12 months|OTHER: Adapted physical activity for 6 months
Sponsor: University Hospital, Bordeaux
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 308
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2027-03
Locations: Cabinet Médical Bergerac, Bergerac, France

Summary:
Type 2 diabetes is on the increase worldwide. Two major risk factors have been identified: overweight and physical inactivity. National and international recommendations encourage general practitioner to guide patients in changing their lifestyle. As regards physical activity in France, general practitioner have been able to prescribe adapted physical activity (APA) for their patients since 2016. In type 2 diabetes, it is known that physical activity interventions are cost-effective. However, these interventions are often too expensive and far removed from real life. It is also known that the benefits of intervention increase up to 18 months, then diminish to zero at 36 months. In Nouvelle-Aquitaine, France, the "PEPS Sport-santé network", offers physical activity coaching for patients who are not sufficiently active: the "Passerelle" program. Patients can benefit from a weekly physical activity session for 6 months.

The investigators would therefore like to assess whether extending the existing "Passerelle program" by 6 months, with one session every 15 days, is effective in maintaining the volume of physical activity 12 months after the end of the intervention.

Primary Outcome Measures: ONAPS-PAQ questionnaire,, Measurement of weekly physical activity volume using the " national observatory on physical activity and sedentariness - physical activity questionnaire" (ONAPS-PAQ), score given in minutes per week : under 150 min/week : Higher early mortality risk, associated with a sharp increase in the risk of chronic diseases above 150min/week : reduced risk of early mortality risk of developing chronic diseases, 12 months after the end of the intervention
Secondary Outcome Measures: Physical activity, changes in physical activity volume at baseline and then every 6 months until the end of the study, Month 0 (inclusion) and Month 6, Month 12, Month 18, Month 24 after inclusion|Sedentariness, ONAPS PAQ sedentariness score :

score in minutes of activity : under 150 min/week : Higher early mortality risk, associated with a sharp increase in the risk of chronic diseases above 150min/week : reduced risk of early mortality risk of developing chronic diseases, At inclusion and 6 months after inclusion and 12 months after the end of the intervention.|Weight change, Difference in weight change between the two groups, At inclusion and 6 months after inclusion and 12 months after the end of the intervention.|Walk test, 6-minute walk test, At inclusion and 6 months after inclusion and 12 months after the end of the intervention.|Therapeutic escalation, Difference in therapeutic escalation level between the two groups, 12 months after the end of the intervention.|HbA1c, Difference in HbA1c between the two groups, At inclusion and 6 months after inclusion and 12 months after the end of the intervention.|Quality of life (SF-36), Difference in quality of life score between the two groups, measured by the SF-36 quality of life scale.

The SF-36 scale ranges from 0 to 100. A low score reflects a perception of poor health, loss of function and the presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain., At inclusion and 6 months after inclusion and 12 months after the end of the intervention.