Evaluation of the Effectiveness of Extending the "Passerelle" System for Prescribing Adapted Physical Activity to Patients With Type 2 Diabetes in Nouvelle-AQUItaine (France)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with type 2 diabetes with initial diagnosis of fasting blood glucose > 1.26 g/l on 2 occasions

Patient aged 18 or over

Patient with a Marshall score ≤ 3

Patient residing in the Nouvelle-Aquitaine region

Disqualifiers

Cardiovascular: unstable angina, stress angina, malignant hypertension, recent myocardial infarction, unstabilized heart disease

Pulmonary: uncontrolled asthma, COPD exacerbation

Endocrine: diabetes with HbA1c > 9%, plantar perforator disease

Pregnant patient

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adapted physical activity for 12 months

    Other intervention

    6 additional months of adapted physical activity after the 6 first months

  • Adapted physical activity for 6 months

    Other intervention

    standard 6-month prescription for adapted physical activity

Treatment groups

308 Participants
are divided into 2 treatment groups
Group A: experimental armExperimental treatment 1 intervention
Group B: control armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 months after the end of the intervention

Secondary outcomes

1

Physical activity

changes in physical activity volume at baseline and then every 6 months until the end of the study

Time frame
Month 0 (inclusion) and Month 6, Month 12, Month 18, Month 24 after inclusion
2

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

Time frame
At inclusion and 6 months after inclusion and 12 months after the end of the intervention.
3

Weight change

Difference in weight change between the two groups

Time frame
At inclusion and 6 months after inclusion and 12 months after the end of the intervention.
4

Walk test

6-minute walk test

Time frame
At inclusion and 6 months after inclusion and 12 months after the end of the intervention.

Other outcomes

Sponsors and contacts

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