Exercise Consultation for Type 2 Diabetes Patients in Real Life (APDT 2)

University Hospital Center of Martinique

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Consultation for physical activity counseling; Behavioral: Specific consultation for physical activity counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01264809

2010-A00450-39 (Other Identifier)

09/B/07

Details and patient eligibility

About

The prevalence of type 2 diabetes is high and expected to increase dramatically in worldwide, in France and especially in the French West Indies.This chronic disease is associated with premature mortality and various debilitating complications which can be prevented by optimal control of glycaemia, blood pressure and lipids. Diabetes management includes lifestyle modification and medication. Despite numerous studies supporting the benefits of frequent physical activity for people with Type 2 diabetes, an estimated 60±80% of this population remain sedentary. Promotion of physical activity in current diabetes care seems to be inadequate.

The aim of this randomized controlled trial is to evaluate the medium-term effectiveness (after 3 and 6months) of exercise consultation in promoting physical activity in outpatients with Type 2 diabetes.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 DM diagnosed within 10 years prior the inclusion

• 18-70 years old

• Signed written informed consent

• Diabetes treatment regimens :

  • diet only
  • oral antidiabetic drug
  • oral antidiabetic drugs with long acting insulin analog
  • oral antidiabetic drugs with GLP 1 analog

Exclusion criteria

• Minors
• Patients with concurrent medical conditions preventing exercise
• Pregnancy or intention to become pregnant during the study
• Inability to read and write French
• History of participating in our education program during the past two years
• Usual sporty activities
• Change in diabetes treatment during the three months prior to study enrollment
• No written informed consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

A : immediate physical activity counseling

Experimental group

Description:

Participants randomized in the experimental group (group A) will receive physical activity counseling during a one-to-one consultation at both baseline and 3 months.

Treatment:

Behavioral: Specific consultation for physical activity counseling

B : later physical activity counseling

Active Comparator group

Description:

Exercise consultation will be realised only at 3 months in the control group(group B). Furthermore, patients of group B will not received any physical activity counseling at baseline.

Treatment:

Behavioral: Consultation for physical activity counseling