Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes is a chronic disease that affects approximately 13% of Portuguese population and is associated with a high cardiovascular mortality by coronary artery disease and cerebrovascular disease and with a serious decline on well-being. Lifestyle changes are widely recommended to the control of type 2 diabetes and its complications. This study aims to analyse the effects of different community-based lifestyle programs (exercise or exercise plus dietary intervention) on health and well-being in patients with type 2 diabetes.

Official Title
-----------------
Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes: Effects on Health and Well-being

Conditions
-----------------
Type 2 Diabetes Mellitus, Diabetes-Related Complications

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Behavioral: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosed type 2 diabetes at least for six months; Both genders; Aged between 50 and 80 years old; Non-smokers; Not engaged in supervised exercise; Community-dwelling; Medical recommendation for lifestyle intervention; Known medical history; Diabetes complications under medical control (poor metabolic control, diabetic foot, diabetic retinopathy, diabetic nephropathy and diabetic autonomic neuropathy; No cardiovascular, respiratory and musculoskeletal contraindications to exercise; No gait and balance problems; Not taking insulin or sulfonylureas for less than three months; Volunteer participation with signed informed consent. Exclusion Criteria: Participation in another supervised exercise program during the study; Participation in another supervised dietary intervention during the study; Aggravation of a diabetes complication or another major health problem;

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Community-based exercise program | Behavioral: Exercise<br>* Community-based exercise program with 3 weekly exercise sessions<br>|
| Experimental: Exercise plus dietary intervention<br>Community-based exercise and dietary intervention program | Behavioral: Exercise<br>* Community-based exercise program with 3 weekly exercise sessions<br>Behavioral: Dietary intervention<br>* Community-based dietary intervention program<br>|
| No Intervention: Control<br>Habitual physical activity and habitual dietary pattern | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Risk | UKPDS Risk Engine | Baseline, 9 and 21 months | 
| Health-Related Quality of Life | SF-36 Health Survey | Baseline, 9 and 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Literacy | General Nutrition Knowledge Questionnaire for Adults | Baseline, 9 and 21 months | 
| Dietary Pattern | 3-day Food Record | Baseline, 9 and 21 months | 
| Physical Fitness | Physical Fitness Test Battery | Baseline, 9 and 21 months | 
| Diabetic Foot Risk | International Working Group on the Diabetic Foot Risk Classification) | Baseline, 9 and 21 months | 
| Exercise-Related Adverse Events | Number of acute injuries or adverse events during exercise sessions | Baseline, 9 and 21 months | 
| Systolic Blood Pressure | mmHg | Baseline, 9 and 21 months | 
| Diastolic Blood Pressure | mmHg | Baseline, 9 and 21 months | 
| Glycemic Control | Glycated Hemoglobin | Baseline, 9 and 21 months | 
| Fast blood glucose | mg/dL | Baseline, 9 and 21 months | 
| Total Cholesterol | mg/dL | Baseline, 9 and 21 months | 
| Body Fat Mass | Bioelectrical impedance analysis | Baseline, 9 and 21 months | 
| Body Lean Mass | Bioelectrical impedance analysis | Baseline, 9 and 21 months | 
| Quality of Sleep | Pittsburgh Sleep Quality Index | Baseline, 9 and 21 months | 
| Symptoms of Anxiety and Depression | Hospital Anxiety and Depression Scale | Baseline, 9 and 21 months | 
| Chronic Pain | Brief Pain Inventory Questionnaire | Baseline, 9 and 21 months | 
| Diabetes-Dependent Quality of Life | Audit of Diabetes-Dependent Quality of Life Questionnaire | Baseline, 9 and 21 months | 
| Habitual Physical Activity | International Physical Activity Questionnaire | Baseline, 9 and 21 months | 
| Waist Circumference | cm | Baseline, 9 and 21 months | 
| Falls Risk | Timed Up and Go Test | Baseline, 9 and 21 months | 
| Sitting-Time | Hours per day | Baseline, 9 and 21 months | 
| Energy Expenditure | kcal/kg/min | Baseline, 9 and 21 months | 
| Body Mass Index | kg/m2 | Baseline, 9 and 21 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Community-based intervention, Exercise program, Dietary intervention program, Health promotion, Subjective well-being, Cardiovascular risk