Promoting Physical Activity in Patients With Type 2 Diabetes (DIAfit)

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effects of a physical activity intervention in patients with type 2 diabetes in a community setting.

Detailed Description
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The aim of this study is to evaluate the effects (before and after) of a physical activity program (DIAfit program) which contains 36 sessions of structured PA and also encourages unstructured PA in an unselected population of patients with type 2 diabetes independent of the selected variant of the program to compare the effects of a standard DIAfit program (3 times per week for 12 weeks) with and alternative program which suggests a more progressive PA activity intensity (starting with one PA session per week during 4 weeks and then twice a week over a period of 16 more weeks (20 weeks total). In total the program also consist of 36 sessions)

Official Title
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Efficacy and Feasibility of a Program to Promote Physical Activity in Patients With Type 2 Diabetes (DIAfit)

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Physical activity intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of type 2 diabetes Exclusion Criteria: Orthopedic complications Diabetic foot ulceration Active  cardiac (ischemia during the exercise test) or stade III peripheral vascular disease Untreated proliferative retinopathy Autonomic neuropathy Active psychiatric, neurological, orthopedic, muscular or rheumatic disease interfering with a participation in a physical activity program Pregnancy

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alternative frequency variant<br>An alternative variant of the DIAfit program (progressive increase of the number of administered PA sessions per week, namely one PA session per week during 4 weeks and then twice a week over a period of 16 weeks) | Behavioral: Physical activity intervention<br>* 36 sessions of physical activity offered at different frequencies<br>|
| Active Comparator: Standard frequency program<br>Standard usual program (3 times per week over a period of 12 weeks) | Behavioral: Physical activity intervention<br>* 36 sessions of physical activity offered at different frequencies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic fitness | Change in aerobic fitness | End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Change in body composition | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | 
| BMI | Change in BMI | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | 
| HbA1c | Change in HbA1c | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | 
| Lipid values | Change in Lipid values | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | 
| Motor performance | Change in motor performance | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | 
| Physical activity | Change in physical activity | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | 
| Well-being | Change in well-being (validated questionnaire) | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | 
| Self-efficacy | Change in self-efficacy (questionnaire) | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | 
| Qualitative evaluation (satisfaction of achievement of personal objectives, evaluation of group session) |  | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | 
| Adherence/Attendance: Number of physical activity sessions attended |  | During the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Physical activity, Body composition, Aerobic fitness, Metabolic control