Exercise Consultation for Type 2 Diabetes Patients in Real Life (APDT 2)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Specific consultation for physical activity counseling
Consultation for physical activity counseling
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring diabetes
Eligibility Criteria
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
Sites / Locations
- CHU de Fort-de-France- Hôpital Pierre Zobda Quitman
- CHU de Bordeaux - Hôpital Haut Lévêque
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A : immediate physical activity counseling
B : later physical activity counseling
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01264809
First Posted
December 20, 2010
Last Updated
December 21, 2010
Sponsor
University Hospital Center of Martinique
Collaborators
Clinique Antilles-Guyane
1. Study Identification
Unique Protocol Identification Number
NCT01264809
Brief Title
Exercise Consultation for Type 2 Diabetes Patients in Real Life
Acronym
APDT 2
Official Title
Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Center of Martinique
Collaborators
Clinique Antilles-Guyane
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A : immediate physical activity counseling
Arm Type
Experimental
Arm 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.
Arm Title
B : later physical activity counseling
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Specific consultation for physical activity counseling
Intervention Description
Specific consultation
Intervention Type
Behavioral
Intervention Name(s)
Consultation for physical activity counseling
Intervention Description
Specific consultation
Primary Outcome Measure Information:
Title
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Benefits obtained after the physical activity counseling
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyne CRASPAG
Phone
(0)596592698
Ext
+596
Email
jocelyne.craspag@chu-fortdefrance.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mickaëlle ROSE
Phone
(0) 596592698
Ext
+596
Email
mickaelle.rose@chu-fortdefrance.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cédric FAGOUR, MD
Organizational Affiliation
CHU de Fort-de-France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Fort-de-France- Hôpital Pierre Zobda Quitman
City
Fort-de-France
State/Province
Martinique
ZIP/Postal Code
97261
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric FAGOUR, MD
Phone
(0)596552241
Ext
+596
Email
cedric.fagour@chu-fortdefrance.fr
First Name & Middle Initial & Last Name & Degree
Miguelle ROSETTE-NARECE, MD
Phone
(0)596552241
Ext
+596
Email
miguelle.rosette-narece@chu-fortdefrance.fr
First Name & Middle Initial & Last Name & Degree
Cedric FAGOUR, MD
First Name & Middle Initial & Last Name & Degree
Miguelle ROSETTE-NARECE, MD
Facility Name
CHU de Bordeaux - Hôpital Haut Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent RIGALLEAU, MD-PhD
Phone
(0)556795679
Ext
+33
Email
vincent.rigalleau@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Henri GIN, MD-PhD
Phone
(0)556795679
Ext
+33
Email
henri.gin@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Vincent RIGALLEAU, MD-PhD
First Name & Middle Initial & Last Name & Degree
Henri GIN, MD-PhD
12. IPD Sharing Statement
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Exercise Consultation for Type 2 Diabetes Patients in Real Life
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