Exercise Consultation for Type 2 Diabetes Patients in Real Life

Study Overview
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Brief Summary
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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.

Official Title
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Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life?

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Specific consultation for physical activity counseling
* Behavioral: Consultation for physical activity counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A : immediate physical activity counseling<br>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. | Behavioral: Specific consultation for physical activity counseling<br>* Specific consultation<br>|
| Active Comparator: B : later physical activity counseling<br>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. | Behavioral: Consultation for physical activity counseling<br>* Specific consultation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daily physical activity measured by SenseWear Pro3 Armband®. Participants were instructed to wear the monitor for seven days during all waking hours except bathing. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefits obtained after the physical activity counseling | The secondary outcome of this study is to compare the benefits obtained 3 and 6 mounths after the physical activity counseling on : Quality of life scores Anthropometric measurement and Body Mass Index (BMI) Body composition measurement Hand grip strength Blood pressure Glycaemic control and cholesterol Medication | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes